Decision Support in California

ResearchDx is a comprehensive diagnostic development and contract research organization (CRO) specializing in in vitro diagnostic (IVD) test development, validation, and commercialization. The company operates three integrated divisions: Contract Services (biomarker discovery, assay development, regulatory filings); Diagnostic Laboratory (CLIA/CAP/ISO 15189 accredited clinical testing under the PacificDx brand); and Diagnostic Manufacturing (ISO 13485:2016 and GMP-compliant kit manufacturing under the CustomDx brand). Core capabilities include custom molecular assay development (PCR, qPCR, ddPCR, NGS, microRNA, protein, flow cytometry, ELISA), analytical and clinical validation, companion diagnostic development, and complete laboratory accreditation consulting. The company is ISO 13485:2016 certified, CLIA approved, CAP accredited, and FDA registered. Recent achievements include FDA 510(k) clearances for GlutenID celiac genetic health risk test and regulatory approvals for companion diagnostics (ProMarkerD for diabetic kidney disease, FibroSIGHT for MASH liver fibrosis detection). ResearchDx serves pharmaceutical companies, diagnostic startups, and established laboratories requiring integrated IVD development from concept through commercialization and contract manufacturing.

Guardant Health is a precision oncology company specializing in blood-based liquid biopsy testing for cancer detection, staging, and treatment monitoring. The company develops and commercializes circulating tumor DNA (ctDNA) tests that enable early cancer screening and inform treatment decisions across all stages of disease. Their primary product lines include Shield (cancer screening via blood test), Guardant Complete (advanced cancer oncology testing), and BioPharma Solutions for drug development and clinical trials. With over 500,000 tests performed and 12,000 physicians utilizing their platform, Guardant Health provides data-driven insights to improve clinical outcomes through biomarker analysis and minimal residual disease (MRD) detection. The company operates a CLIA-certified laboratory in the Bay Area and maintains regulatory compliance for commercialized diagnostics. Their technology supports personalized cancer care by identifying genetic mutations, tumor characteristics, and treatment response markers from blood samples, reducing reliance on invasive tissue biopsies and enabling earlier intervention.

Simple HealthKit is a healthcare infrastructure platform that delivers end-to-end solutions for member engagement, health screening programs, and connected care delivery. The company operates CLIA-certified laboratory infrastructure and provides vertically integrated screening services paired with digital patient engagement tools. Their platform serves health plans, biopharma companies, public health agencies, and retail pharmacy partners. Simple HealthKit specializes in closing HEDIS gaps, improving Star Ratings, and launching preventive care programs rapidly—typically deployable within weeks. The platform combines AI-driven digital-first tools with high-touch, at-home screening programs, supporting enrollment, screening workflows, and longitudinal patient engagement. Their enterprise-ready software integrates with existing health systems and provides real-time analytics, participation tracking, and audit-ready reporting. Clients include major health plans, insurers, retailers (Walmart, Amazon, CVS Pharmacy), state health departments, and public health organizations. The company emphasizes clinical accuracy through CLIA-certified lab operations while maintaining consumer-friendly, accessible healthcare experiences.

Soundable Health develops proprietary AI-based sound analysis technology that transforms ambient sounds and acoustic signals into digital audio biomarkers for clinical decision-making. The company's platform captures, analyzes, and converts sound data into actionable medical insights to support non-invasive diagnostics across multiple clinical fields. Their technology enables healthcare providers to leverage audio biomarkers—measurable acoustic indicators derived from patient sounds—to improve diagnostic accuracy, patient outcomes, and clinical workflows. The platform is designed for global deployment across healthcare settings, with applications spanning multiple specialties. Soundable Health has presented at major medical and technology conferences including the AUA Annual Meeting and SK AI Summit, and has been recognized as part of SK Telecom's K-AI Alliance, indicating growing clinical and commercial validation. The company positions itself at the intersection of audio signal processing, machine learning, and clinical diagnostics, addressing a gap in non-invasive, standardized acoustic measurement for healthcare.

CliniComp International is a healthcare IT vendor specializing in integrated electronic health record (EHR) solutions with native artificial intelligence capabilities. The company provides a comprehensive System as a Service (SYaaS) model that bundles software, hardware, implementation services, training, ongoing support, and continuous optimization into a single transparent contract. CliniComp's New Era EHR Solution Suite covers inpatient, ambulatory, ancillary operations, and revenue cycle management (RCM) within a single unified platform. The system features native AI embedded throughout clinical workflows, real-time advanced analytics, and comprehensive medical device integration that automates data capture from hundreds of bedside devices directly into patient records. Key differentiators include: (1) true interoperability built into core architecture for longitudinal patient records; (2) all integration and services included upfront with no hidden costs; (3) rapid implementation achievable in months rather than years; (4) proven reliability with decades of continuous operation, including documented zero-downtime records exceeding 25 years at some facilities. CliniComp serves health systems of all sizes, including Veterans Affairs facilities, rural hospitals, and large academic medical centers. The company emphasizes reducing clinician administrative burden, improving care coordination, enhancing patient safety, and delivering measurable ROI. CliniComp has received industry recognition including the 2025 MedTech Breakthrough Award, Healthcare Technology Review Top 50 award, and the 2026 Trailblazer in Healthcare Technology Pinnacle Award for its SYaaS model innovation.

VivoSense Inc. is a wearable sensor Contract Research Organization (CRO) specializing in digital health technology (DHT) for clinical trials. Founded 14+ years ago, the company provides end-to-end wearable sensor services across 20+ therapeutic areas, serving pharmaceutical sponsors, contract research organizations, and digital health innovators in 30+ countries. The company's core offering includes DHT strategy consultation, wearable device selection and vendor management, protocol development, data collection operationalization, data cleaning and analysis, and clinical validation. VivoSense operates a proprietary DHT platform designed for compliance and auditability in clinical trial environments. The platform enables collection and processing of high-volume, complex sensor data into structured, actionable insights. The company has deployed 70+ wearable sensors to date across diverse disease areas. Clinical operations and data science teams leverage decades of combined experience in digital health technology implementation and sensor data analytics. Recent regulatory engagement includes qualification discussions with the European Medicines Agency (EMA) regarding MEADOW-RETT-BR, a DHT-based measure of apnea events in Rett syndrome patients. Notable partnerships include Biogen, Roche, argenx, Mayo Clinic, and GSK. Services span three phases: study startup (DHT strategy and measure selection), study conduct (operationalization and data collection), and study closeout (data investigation and statistical validation).

CogniFit is a digital health platform offering scientifically validated cognitive assessment and brain training software. The company develops computerized cognitive testing batteries (CAB) and adaptive brain training games targeting 20+ cognitive domains including memory, attention, executive function, perception, and coordination. CogniFit serves multiple market segments: healthcare professionals (neuropsychological assessment and rehabilitation), clinical research (cognitive endpoints in trials), educational institutions (student cognitive evaluation), corporate wellness (employee mental health), and direct-to-consumer users. The platform includes personalized, difficulty-adaptive training programs backed by 20+ years of published research. CogniFit maintains clinical validation through partnerships with 6,501+ clinics and research institutions, generating detailed progress reports and cognitive age assessments. The software is available via web and mobile applications (iOS/Android). The company supports multiple account types for patient management, research participants, educational cohorts, family use, and employee wellbeing programs. CogniFit does not manufacture hardware devices but operates as a SaaS provider of cognitive health software with regulatory claims regarding cognitive training efficacy and digital therapeutics validation.

JLK Inc is a medical artificial intelligence company headquartered in Santa Clara, CA, specializing in AI-driven diagnostic solutions for neurological and oncological conditions. The company develops MEDIHUB, a comprehensive AI-based platform suite that processes multiple imaging modalities—including CT, CTA, MRI, MRA, digital pathology, endoscopy, X-ray, and mammography—to support clinical decision-making across stroke management and cancer detection. The MEDIHUB Stroke platform addresses the complete care continuum from acute-phase intervention to chronic-phase prognostic prediction, with integrated mobile applications enabling rapid diagnosis and treatment planning. MEDIHUB also covers dementia assessment and brain aging analysis, plus detection and analysis of 12 cancer types including prostate, breast, gastric, and colorectal cancers. JLK positions its technology as a workflow optimization tool designed to reduce door-to-treatment time in stroke management and improve patient outcomes through early, accurate disease detection. The company targets hospital systems, imaging centers, and diagnostic facilities requiring AI-powered image analysis and clinical decision support. No specific FDA 510(k) clearances, ISO certifications, or regulatory credentials are mentioned on the website.

Athelas is a healthcare software company providing an integrated platform for revenue cycle management (RCM), electronic health records (EHR), and AI-powered clinical documentation. The company offers four primary products: (1) Athelas RCM (formerly RCM Insights), an AI-driven platform for claim management, denial defense, and revenue optimization through automated claim processing and predictive analytics; (2) Ambient AI, an intelligent medical scribe and copilot system that automatically generates clinical notes, CPT/ICD-10 codes, and compliance checks with real-time EMR integration; (3) Athelas Air, a modern EHR designed for ambulatory practices with features including AI-powered patient intake, autonomous receptionist, patient portal, pre-visit workflows, and integrated documentation; and (4) Athelas Agents, customizable AI assistants for scheduling, insurance authorizations, appeals, and data retrieval from external systems. The platform serves diverse healthcare organizations including urgent care, physical therapy, orthopedics, dermatology, ENT, and specialty practices. Key capabilities include automated remittance reconciliation, AI-powered portal data extraction, revenue analytics dashboards, parallel scribing for overlapping patient encounters, compliance nudges, and autonomous patient engagement. Customers report measurable outcomes including improved first-pass claim rates (95%+), increased collections ($17–$3.6M monthly), reduced denial rates (1–1.5%), and significant time savings (2+ hours per provider daily). The company emphasizes security, customization, and seamless EHR integration across major platforms.

Sirona Medical is a cloud-native software company specializing in radiology image management, diagnostic reporting, and AI-driven workflows. The company develops Rad OS™, an integrated platform that unifies PACS (Picture Archiving and Communication System), reporting, viewer, and worklist functionality into a single browser-based operating system for radiologists. The platform leverages AWS cloud infrastructure to enable radiologists to read studies from anywhere without legacy on-premise servers or software downloads. Sirona's core offering includes: (1) PACS Archive—a fully managed AWS-backed system with 99.99% availability and no maintenance overhead; (2) Pixel-Powered Reporter—an AI-driven reporting engine using agentic AI, proprietary NLP, and a radiology-specific large language model (LLM) to auto-generate impressions and pre-draft structured reports; (3) Integrated Viewer with patented Ontology classification that organizes studies and auto-places measurements into reports; and (4) Unified Worklist aggregating multiple sites and systems with embedded AI for context prioritization. The company integrates all clinical data feeds (DICOM, HL7, speech) and employs multimodal AI capabilities including speech-to-action agentic agents that execute workflow tasks. Pixel-to-report functionality (auto-placement of findings into appropriate report sections) is noted as undergoing regulatory review. Sirona operates a business model serving radiology practices, imaging centers, and health systems. The company has raised $110M since inception, has 30+ contracted customers across 110+ integrated sites, and maintains partnerships with AI vendors (RevealDX, Koios) for specialized diagnostic capabilities such as lung cancer screening. The platform supports remote access via SpaceX Starlink and operates with HIPAA compliance on AWS infrastructure.

LVIS Corporation is a San Francisco Bay Area–based medical technology company specializing in neural information analysis and EEG diagnostics software. The company develops patented brain-imaging visualization and analysis technologies that decode brain network activity to support neurological disease diagnosis and clinical workflows. LVIS's flagship product is NeuroMatch®, a cloud-based SaaS platform that automates and enhances EEG examination, source localization, and 3D/4D brain visualization. NeuroMatch has received FDA 510(k) clearance (K250239) in the United States and MFDS regulatory clearance in South Korea. The platform addresses critical gaps in neurological healthcare capacity: the shortage of neurologists (1 per 23,259 people), sub-optimal clinical workflows, and surging demand for neurological diagnosis. LVIS is backed by prestigious academic partnerships, including Stanford Byers Center for Biodesign Faculty Fellowship, Stanford StartX incubator, and NVIDIA Inception Program support. The company has received research grants from the Stanford Spectrum Center, LivaNova, and the Epilepsy Foundation. Leadership includes neuroscience and engineering experts; the company was founded by Jin Hyung Lee, PhD. NeuroMatch was named a 2026 Edison Awards finalist. The company operates with headquarters in Palo Alto, California, and additional offices in Gangnam and Daegu, South Korea, serving both US and international markets.

Ceribell develops point-of-care EEG systems for rapid seizure detection and monitoring in critical care settings. The company's flagship product, a portable EEG platform integrated with the CLARITY® AI algorithm, enables bedside detection of seizure activity, including non-convulsive seizures, in ICUs, emergency departments, and neurology units. CLARITY® is FDA-cleared for pediatric and neonatal patients, representing the first and only FDA-cleared seizure detection algorithm for newborns preterm and up. The system delivers 95% sensitivity and 97% specificity for status epilepticus detection with 99.9% negative predictive value. Ceribell's secure cloud portal features FedRAMP High cybersecurity authorization for telemedicine consultation and remote EEG interpretation. Clinical evidence demonstrates the platform is associated with 4.1-day shorter median ICU stays and improved neurological outcomes compared to conventional EEG workflows. The company supports hospitals with ongoing in-person and virtual training. Target markets include intensive care units, emergency departments, and neurology departments in acute-care hospitals. Ceribell holds multiple FDA clearances (510(k)), CE mark certification, and has published 45+ peer-reviewed publications validating diagnostic accuracy and clinical utility in critical care populations.

Vivid Vision Inc develops digital vision care solutions for diagnosis and therapeutic training of binocular vision disorders and visual field assessment. The company manufactures two core platforms: Vivid Vision (VV), an advanced vision training system for amblyopia, strabismus, and convergence insufficiency delivered via VR-based home training; and Vivid Vision Perimetry (VVP), a precision at-home microperimetry system for clinical visual field testing in retinal and glaucoma disorders. VVP is validated for use as a functional vision endpoint in clinical trials for geographic atrophy, age-related macular degeneration, and glaucoma therapeutics. The company also offers EYEBAB VT, a therapeutic exercise platform with dozens of vision activities for clinic-based intervention. With over 100,000 patients in 50+ countries since 2014, Vivid Vision systems are used by major ophthalmic pharmaceutical companies and leading research institutions. Published studies demonstrate VVP achieves 6.8× better precision than standard automated perimetry, 2× better fixation stability, and 99% adherence to at-home testing protocols. The platform has been evaluated by premier institutions including the Retina Foundation of the Southwest and Duke University Medical Center. Vivid Vision Perimetry is clinically validated and industry-ready for phase I and II ophthalmology trials.

Q Bio operates a preventive health clinic offering comprehensive diagnostic assessment and longitudinal health monitoring through an integrated platform combining MRI imaging, EKG, biometric measurement, genetic analysis, and wearable data integration. The company has developed a proprietary digital health platform that creates a 3D digital twin of patient biology, presenting nine biological subsystems through an interactive dashboard. The Q Exam, conducted at their Redwood City, California clinic, is a 75-minute comprehensive assessment that includes full-body MRI, ECG/EKG, biometric and vital signs collection, genetic measurements, and integration of wearable device data. The platform delivers AI-assisted analytics to support clinical decision-making and trend analysis from longitudinal patient data. Q Bio positions itself as a platform provider for clinics and longevity-focused partners seeking to offer preventive health services beyond standard physical examinations. The company has deployed its system at its own clinic and reports successful integration at other major longevity partners. The team comprises PhDs, MScs, and MDs from world-class institutions. The service model includes concierge scheduling, fast results delivery via personalized health dashboard, and post-exam consultation with Q Bio physicians. The platform is designed to be embedded into existing clinic workflows and integrated health stacks.

Signos is an AI-powered metabolic health platform that combines continuous glucose monitoring (CGM) with personalized weight management guidance for non-diabetic and metabolically-conscious consumers. The platform integrates Dexcom G7 CGM sensors with a proprietary mobile application that uses machine learning to analyze glucose patterns and predict individual metabolic responses to food, exercise, sleep, and stress. Members receive real-time glucose tracking, personalized eating and movement recommendations, registered dietitian support, and weekly metabolic reporting. The service is FDA-cleared and HSA/FSA-eligible, offered through direct consumer channels and employer-sponsored wellness programs. Clinical outcomes show 86% of members report success in their first month, with significant weight loss and improved metabolic stability.

EntroGen, Inc. is a molecular diagnostics company specializing in oncology and personalized medicine solutions. The company develops and manufactures FDA-approved and research-use-only (RUO) PCR-based assays for cancer biomarker detection, companion diagnostics, and minimal residual disease (MRD) monitoring. Core product portfolio includes the CRCdx® RAS Mutation Detection Kit (FDA-approved companion diagnostic for KRAS and NRAS mutations in colorectal cancer), NPM1 One-Step MRD Kit for acute myeloid leukemia detection, DPYD Genotyping Kit for pharmacogenomic assessment, and Microsatellite Instability (MSI) Detection Kit. EntroGen manufactures the Benchbot® 4800 laboratory automation platform designed to streamline workflow from sample preparation to PCR plate setup in four steps. The company offers three integrated product lines: automation equipment, molecular reagents/assays, and analysis software. All products are manufactured to ISO 13485 quality standards. EntroGen serves clinical laboratories, hospital pathology departments, and oncology centers globally, supporting treatment decision-making through molecular testing. The company participates in industry conferences including the World Clinical Biomarkers & Companion Diagnostics Summit, indicating active engagement in the molecular diagnostics and precision oncology markets.

Universal Brain Inc. develops a medical-grade EEG system designed for precision psychiatry, focusing on objective, brain-based diagnosis and treatment of psychiatric conditions, primarily depression. The company has engineered a next-generation EEG wearable headset that captures event-related potentials (ERPs)—brain responses to cognitive and emotional stimuli—and pairs it with Neurotique™, a proprietary digital interface and AI-driven software algorithm that translates raw EEG data into actionable clinical insights. The platform enables neurotyping: the classification of patients based on functional brain measures derived from EEG, allowing clinicians to identify subtypes of psychiatric disorders and tailor treatment accordingly. Universal Brain's approach addresses the heterogeneity of psychiatric conditions by examining core neural systems including attention, memory, and emotional processing. The system is currently investigational and intended for use in clinical settings to aid treatment decision-making and support psychiatric clinical drug trials. The company's leadership includes a psychiatrist founder/CEO (Kazu Okuda, M.D.) and Chief Scientist with expertise in clinical neuroscience (Greg Hajcak, Ph.D.), indicating strong research-clinical integration. The platform represents a shift toward objective, neurobiological markers rather than symptom-based diagnosis alone.

New Lantern is a cloud-native unified radiology platform that combines worklist management, PACS image viewing, and AI-powered reporting into a single browser-based workspace. The platform eliminates the need for radiologists to log into multiple separate systems; instead, all clinical functions—case selection, image analysis, and report generation—occur within one integrated application. The platform features three core components: (1) Intelligent Worklist, which automatically prioritizes cases by STAT status, modality, and assignment across multiple sites with zero manual intervention and automatic study precaching; (2) Ultra-fast Cloud Viewer, a sub-second DICOM viewer with intelligent precaching, hanging protocol learning, and full 3D and specialty modality support accessible from any browser on any device without VPN or local installation; and (3) Curie AI Reporting, a clinical decision-support tool that pre-drafts structured radiology reports in the radiologist's own dictation style, learning from edits over time while keeping the radiologist fully in control of review and sign-off. New Lantern is a complete PACS replacement, not an overlay system. Historical imaging data migrates with full continuity, preserving prior studies and reports. The platform integrates natively with major EHR systems including Epic and Oracle Health via HL7 and FHIR standards, with reports flowing directly into the EHR upon radiologist sign-off. Implementation is rapid (4–8 weeks for full deployment) with no on-premises server provisioning or hardware installation required. New locations can go live in days. The company is FDA-registered as a medical device and maintains enterprise-grade security controls and Business Associate Agreements. Radiologists report approximately $200K in incremental annual revenue per practitioner through improved workflow efficiency and TAT reduction.

UpDoc is a Remote Patient Intervention (RPI) platform combining agentic AI with physician oversight to deliver proactive, evidence-based care for chronic disease management. The platform enables continuous, personalized patient monitoring and intervention between clinical visits through EHR integration and mobile application interfaces. UpDoc's technology operates under physician supervision, automatically monitoring patient metrics (including blood glucose and other chronic disease indicators), driving timely patient engagement, and triggering clinical escalations before deterioration occurs. The platform is designed to increase medication adherence, improve chronic disease outcomes, and expand clinical capacity without proportional increases in labor costs. Clinical validation, published in JAMA Network Open, demonstrated 3x improvement in chronic disease metrics, 65% increase in medication adherence, and 5x expansion of clinical capacity using equivalent staffing. The system targets healthcare organizations, health plans, employers, and healthcare systems seeking to address care gaps between patient visits and reduce both clinical burden and total cost of care. UpDoc is trusted by major medical institutions including Mayo Clinic, UCSF, and University of Minnesota, and has backing from technology and healthcare leaders.

AgileMD is a clinical decision support software company providing FDA-cleared AI and workflow integration solutions for hospital systems. The platform consists of two primary product lines: eCART™, an FDA-cleared clinical deterioration early warning system that uses machine learning to predict patient risk and guide ICU transfer decisions, and Clinical Pathways, a highly integrated guidance system that standardizes clinical protocols and reduces variation across care settings. eCART leverages nearly 3 million patient encounters from 28 hospitals across 6 health systems for training and validation, with peer-reviewed publications demonstrating reduced mortality, decreased length of stay, and lower direct variable costs. Clinical Pathways enable rapid deployment of evidence-based protocols directly into EHR workflows without extensive IT support, covering 4,800+ active pathways across adult, pediatric, and neonatal settings in ambulatory, emergency, inpatient, ICU, and women's health domains. The platform is SOC-II and HIPAA compliant, operates as a cloud-based hosted service requiring no on-site hardware, and serves 400+ hospitals with 150,000+ clinical users across 4.4+ million patient encounters. AgileMD's solutions focus on reducing clinical burden, standardizing care delivery, and enabling real-time clinical decision support embedded seamlessly within existing EHR workflows.

Fortuna Helix is a genomic analysis and disease risk prediction company specializing in polygenic risk score (PRS) modeling for proactive disease prevention and personalized health management. The company provides comprehensive DNA analysis to assess individual susceptibility to 37 major diseases and BMI obesity risk, leveraging advanced statistical modeling and genetic data analysis techniques. Fortuna Helix delivers actionable genomic insights to both healthcare providers and patients, enabling early intervention and informed lifestyle modifications. Their product portfolio includes Disease Prediction analysis, Obesity Prediction and Prevention modules, Height Prediction, and Genetic Health Indicators. The platform functions as a clinical decision-support tool, translating complex genetic data into personalized preventive guidance. Fortuna Helix serves both B2C patients seeking proactive health management and B2B healthcare providers integrating genomic risk assessment into preventive care workflows. The company operates from Irvine, California, and focuses on advancing precision medicine through accessible genomic insights that empower individuals to make informed decisions about disease prevention and self-care based on their unique genetic profiles.

Thirdwayv is an IoT connectivity and cybersecurity software company specializing in secure, connected medical devices and healthcare applications. The company provides end-to-end security solutions—from hardware root of trust through cloud infrastructure—for safety-critical IoT deployments in consumer medical devices, connected hospitals, home healthcare, electrical stimulation and drug delivery systems, and biometric monitoring. Core product lines include AppAuth™ (device and customer authentication, remote attestation), SecureConnectivity™ (application-layer encryption across Bluetooth, NFC, LTE, Ethernet), SeamlessConnect™ (seamless device-to-gateway connectivity), and RecordAuth™ (blockchain-based data authenticity for supply chains). Thirdwayv holds FDA clearances enabling partners to meet FDA cybersecurity guidelines for medical devices and has demonstrated expertise in connected diabetes management, pacemakers, nerve stimulators, defibrillators, insulin pumps, thermometers, blood pressure monitors, glucose meters, and pulse oximeters. The company also serves connected car (OTA firmware updates, infotainment security, smartphone keyless entry) and asset-tracking markets (cold chain, surgical implant track-and-trace, hospital inventory management, retail item tracking). Leadership includes executives from Motorola, Broadcom, and GE; the advisory board includes former Qualcomm, Google, BlackBerry, and FDA officials. Thirdwayv positions itself as a "nucleus of trust" for IoT ecosystems, emphasizing security-by-design from the semiconductor level upward.

Endonovo Therapeutics is a commercial-stage developer of non-invasive wearable medical devices delivering proprietary Electroceutical® Therapy for inflammatory conditions, cardiovascular diseases, and central nervous system disorders. The company's flagship product, SofPulse®, harnesses bioelectricity to restore electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing. Endonovo's Electroceutical® Therapy is FDA-Cleared for palliative treatment of pain and post-surgical edema, with CE Mark for wound healing promotion and pain/edema treatment. The company holds CMS National Coverage for chronic wound treatment. Current pipeline includes clinical-stage therapies targeting ischemic heart disease, acute concussions, post-concussion syndrome, traumatic brain injury (TBI), and multiple sclerosis. The technology platform operates through pulsed electromagnetic field (PEMF) delivery mechanisms designed as wearable, non-invasive systems. Endonovo is publicly traded on the OTCQB market (ticker: ENDV) and demonstrates commitment to evidence-based therapeutic development with regulatory-cleared and clinically-validated products.

Vektor Medical develops vMap, an FDA-cleared and CE-marked arrhythmia analysis software platform that uses artificial intelligence to extract diagnostic insights from standard 12-lead ECGs. vMap provides non-invasive, four-chamber cardiac mapping and analysis for seven arrhythmia types, including atrial fibrillation, atrial and ventricular tachycardia, ventricular fibrillation, pacing, premature atrial and ventricular complexes (PACs and PVCs), and orthodromic atrioventricular reentrant tachycardia. The software is designed to integrate into current cardiac ablation workflows, improving procedural outcomes and efficiency for electrophysiologists and cardiac care teams. vMap addresses a significant clinical need in arrhythmia management; arrhythmias account for approximately 10% of global deaths, and over 25% of adults over age 40 develop serious arrhythmias. The company is based in San Diego and was recognized as UC San Diego Chancellor's Innovation Awards Startup of the Year in 2024. Regulatory status: FDA 510(k) clearance and CE mark.

BIOVICA International AB is a Swedish biotech company specializing in blood-based cancer diagnostics and treatment monitoring. Their flagship product is DiviTum® TKa, a blood test designed to monitor disease progression in solid tumors by measuring circulating tumor cell proliferation markers. The test is positioned for oncology applications, particularly in breast cancer management, to assess treatment efficacy and predict patient response to therapies such as CDK4/6 inhibitors and endocrine therapies. The company has conducted extensive clinical validation with over 4,500 patients enrolled in studies and maintains 28 peer-reviewed publications. DiviTum® TKa serves pharmaceutical companies, oncologists, and cancer patients by providing early indicators of treatment response—potentially within the first weeks of therapy—enabling more informed treatment decisions and disease monitoring. The company engages with major pharmaceutical partners across 32 pharma projects. Clinical evidence comes from leading oncology centers including University of Michigan Rogel Cancer Center and Washington University School of Medicine. The test represents a liquid biopsy approach for precision oncology decision-making.

EnlitenAI develops Neuroliten, an FDA-registered Class I Software as a Medical Device (SaMD) platform for decision support in the treatment of neurological and neurobehavioral disorders. The platform specializes in seizure management for drug-resistant epilepsy and is designed to support clinical decision-making for conditions including autism spectrum disorder, PTSD, anxiety, depression, and Parkinson's disease. The system integrates multimodal data streams from FDA-cleared wearables and implantables to deliver personalized, data-driven treatment recommendations and drug-device titration guidance. Neuroliten was registered with the FDA on January 9, 2026, under OUG product code classification. The company operates with a device-agnostic architecture that translates patient-specific data into actionable clinical insights, moving away from trial-and-error approaches in neurological care. EnlitenAI's team includes clinical expertise from UCSF Neurology, computational sciences specialists, and digital health entrepreneurs. The platform is designed for use by neurologists, patients, caregivers, and pharmaceutical partners. The company follows a phased regulatory strategy with additional functionalities under development for future submission. Based in Tracy, California, with a regional office in the greater Sacramento area, EnlitenAI focuses on precision neurological and neurobehavioral care delivery.

Genetic Signatures Limited is a molecular diagnostics company specializing in the development and commercialization of proprietary real-time PCR-based detection systems for infectious disease screening. The company's core platform, 3base™, utilizes streamlined sample processing methods linked to highly multiplexed real-time PCR assays to simultaneously detect multiple pathogen targets faster than conventional methods. Primary product line includes the EasyScreen™ brand of detection kits, which employ DNA methylation pattern identification and sequence simplification technology. The company has achieved FDA 510(k) clearance for the EasyScreen™ Gastrointestinal Parasite Detection Kit, now distributed through leading US clinical laboratories. Additional offerings include Analyte Specific Reagents (ASRs) for laboratory-developed test applications. Genetic Signatures serves clinical laboratories, diagnostic facilities, and healthcare systems requiring rapid, multiplexed infectious disease identification. The company maintains regulatory compliance with FDA standards and positions itself as a specialist in molecular diagnostics innovation, with particular expertise in gastrointestinal parasite and pathogen detection. Operations span both US and international markets, with documented presence in the US healthcare diagnostics sector.

Neurotrack Technologies develops FDA-registered digital cognitive screening tools for early detection of mild cognitive impairment (MCI), Alzheimer's disease, and related dementias. The platform delivers standardized, cloud-based cognitive assessments in as little as 3 minutes, enabling rapid baseline measurement and DSM-5-aligned diagnostic scoring. The solution integrates with all major EHR systems, deploys on any device, and supports remote and in-clinic administration. Neurotrack serves healthcare providers, health plans, home health agencies, and primary care settings, with over 15,000 clinicians and major health systems (Providence, Sutter Health, Stanford Medicine) as customers. The company emphasizes operational efficiency—reducing administration time by 10+ minutes compared to traditional tests like Mini-Cog, MMSE, and MoCA—while improving clinical outcomes through actionable care plans and population health management for value-based reimbursement models. Clinically validated by 375+ peer-reviewed publications and 25 core studies, with funding from the National Institute on Aging and the Gates Foundation. SOC 2- and HIPAA-compliant. Founded in 2012 with a singular focus on closing the dementia detection gap.

iMediSync is a South Korean digital mental health platform company specializing in AI-driven biomarker detection and analysis for brain and cardiac health. The company designs and manufactures proprietary dry-electrode wearable headsets for non-invasive measurement of brainwave (EEG) and heart rate variability (HRV) signals without gel or conductive pastes. iMediSync operates three primary product lines: iSyncWave (wireless dry-electrode EEG measurement headset with integrated care capabilities), iSyncBrain (cloud-based AI brainwave analytics software with quantitative EEG analysis and cognitive impairment screening), and iSyncHeart (cloud-based HRV analytics for stress, anxiety, and depression monitoring). The company has obtained regulatory clearance in South Korea (식약처 approval for both device and software), US FDA Class II clearance for iSyncWave, and FDA software device authorization for iSyncBrain. iMediSync maintains proprietary age- and gender-stratified EEG reference databases and employs machine learning models for automated noise removal, brain mapping, and clinical decision support. Applications span clinical neurology, psychiatry, occupational health screening, and research collaborations. The platform supports early detection of mild cognitive impairment and stress-related autonomic nervous system imbalance.

Rhythm AI Inc develops software-based diagnostic and decision-support solutions for cardiac electrophysiology. The company's flagship product, STAR Apollo Mapping System, is an AI-enabled software platform designed to analyze real-time data from existing electrophysiology (EP) systems for the treatment of atrial fibrillation (AF). STAR Apollo uses proprietary algorithms based on electrophysiological principles to identify repetitive patterns of activation (RPAs) and early sites of activation (ESAs) within arrhythmias, enabling electrophysiologists to locate potential AF drivers and develop individualized ablation strategies. The system integrates into current EP lab workflows without requiring new hardware infrastructure, allowing physicians to create personalized treatment plans based on comprehensive rhythm analysis. The technology targets hospital and specialty cardiology centers performing catheter ablation and electrophysiological mapping procedures.

FaceHeart Corporation develops FDA-cleared contactless video-based vital signs measurement software powered by artificial intelligence image recognition technology. The company's flagship product, FaceHeart Vitals™ (registered as FH Vitals SDK), is a Software as Medical Device (SaMD) that measures multiple vital parameters from a 50-second facial scan without requiring wearables or connected devices. The solution has received two FDA 510(k) Class II clearances: one for Heart Rate measurement (k223622) and one for Respiration Rate measurement (k243966). The platform measures heart rate, respiration rate, blood pressure, oxygen saturation, heart rate variability, stress index, and screens for atrial fibrillation. Additional biomarkers in beta development include HbA1c, hemoglobin, and cholesterol. FaceHeart Vitals™ is designed for seamless integration with diverse devices and platforms including mobile phones, laptops, desktops, digital picture frames, smart TVs, smart mirrors, security cameras, and robots, eliminating the need for proprietary hardware. Primary applications span telemedicine and remote healthcare (enabling spot checks, diagnostics, and triage), digital health and wellness applications, and smart device integration for both medical and consumer settings. The technology provides medical-grade accuracy trained on millions of datasets and is compatible with various platforms and operating systems. FaceHeart serves healthcare providers, telemedicine platforms, digital health application developers, and smart device manufacturers seeking to integrate contactless vital sign monitoring. The company has garnered industry recognition, including selection for the Forbes Asia 100 to Watch 2025 list and the MedTech Breakthrough Awards 2025 for Best Biometric Sensor Solution.