- 201New productsSource · Medical Device Network
ADA26: Dexcom’s G7 CGM helps TD2 diabetics not on insulin manage glucose levels
Dexcom presented data on its G7 continuous glucose monitoring system showing efficacy in type 2 diabetes patients not requiring insulin therapy. The company expects the findings may influence clinical practice patterns for this patient population.
- 202RegulationSource · Medical Device Network
Tandem secures CE mark for AID systems in T2D and T1D with pregnancy
Tandem Diabetes Care obtained CE mark approval for expanded indications of its automated insulin delivery systems, now cleared for use in type 2 diabetes and type 1 diabetes patients who are pregnant. The expanded authorization widens the addressable patient population in European markets for Tandem's AID platform.
- 203TechnologySource · MedCity News
When Geopolitics Becomes a Patient Safety Issue: Protecting Healthcare in an Era of Targeted Cyberattacks
Healthcare organizations face growing cybersecurity threats driven by geopolitical actors seeking disruption rather than ransom, according to analysis of targeted infrastructure attacks. The shift from financially motivated cybercrime to state-sponsored chaos-focused campaigns poses distinct operational and safety risks that most providers are unprepared to address, requiring new defensive strategies and vendor partnerships.
- 204RegulationSource · Medical Device Network
Zepto Life Technology’s mould infection panel obtains FDA breakthrough designation
Zepto Life Technology's FungiFlex mould panel has received FDA Breakthrough Device designation. The panel identifies 14 clinically important mould species using cell-free fungal DNA detection in plasma, enabling faster diagnosis of invasive fungal infections in immunocompromised patients.
- 205MarketSource · Medical Device Network
Sophia Genetics and MSK join forces to develop precision oncology hub
Sophia Genetics and Memorial Sloan Kettering Cancer Center have partnered to develop a precision oncology hub focused on multimodal approaches. The collaboration aims to advance diagnostic and treatment strategies in oncology through combined expertise in genetic analysis and clinical care.
- 206MarketSource · Medical Design & Outsourcing
Cordica Medical acquires RapidWerks micro-molding capability
Cordica Medical, a medical device contract development and manufacturing organization, has acquired RapidWerks' micro-molding capabilities. The acquisition expands Cordica's precision manufacturing capacity for miniaturized medical devices, adding dedicated automated micro-molding for mass production to its integrated design and manufacturing services.
- 207New productsSource · Medical Device Network
Roche develops RUO PCR assay to detect rare Ebola Bundibugyo virus
Roche has developed a research-use-only (RUO) PCR assay for rapid detection of Ebola Bundibugyo virus. The molecular test leverages Roche's existing PCR platform capabilities to address detection of this rare viral variant.
- 208RegulationSource · Medical Device Network
FDA approves GE HealthCare’s MIM Contour ProtégéAI+ 2.0 software
GE HealthCare received FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, an AI-powered software tool. The clearance expands GE's portfolio of computational aids for medical imaging and oncology planning workflows, enabling vendors and providers to adopt the updated solution for clinical use.
- 209MarketSource · MedCity News
CereVasc Rakes In $85M to Challenge Traditional Brain Shunt Surgery
CereVasc closed an $85 million Series C funding round to support development of its eShunt system, a minimally invasive alternative to conventional brain shunt surgery for hydrocephalus treatment. The company expects to complete a pivotal clinical trial and submit to the FDA in 2027.
- 210New productsSource · Medical Design & Outsourcing
Edwards Lifesciences makes a simple change for a first-of-its-kind tricuspid valve
Edwards Lifesciences received FDA approval in May 2026 for Triformis Resilia, the first surgical valve designed specifically for the tricuspid position. The device incorporates a design modification that addresses an unmet clinical need in tricuspid valve replacement, marking a new product entry in the structural heart device market.
- 211MarketSource · Medical Device Network
CereVasc raises $85m to advance hydrocephalus treatment
CereVasc raised $85 million to advance development of eShunt, an implantable system for treating normal pressure hydrocephalus through cerebrospinal fluid drainage. The funding supports clinical advancement and commercialization of the device.
- 212MarketSource · Medical Device Network
ResMed completes $340m Noctrix Health acquisition
ResMed completed its acquisition of Noctrix Health for $340 million. Noctrix's lead product, Nidra, is a neuromodulation device targeting peroneal nerves to treat restless leg syndrome symptoms. The deal expands ResMed's portfolio in sleep and respiratory care.
- 213RegulationSource · Medical Device Network
Medtronic seeks FDA clearance for Hugo RAS system
Medtronic has filed with the FDA seeking to expand clearance for its Hugo RAS robotic-assisted surgery system to general and gynaecologic surgery indications. The company submitted multiple regulatory filings to broaden the platform's approved use cases beyond its current scope.
- 214New productsSource · Medical Device Network
Insulet launches algorithm improvements for Omnipod 5 AID system in US
Insulet has begun distributing an updated version of its Omnipod 5 automated insulin delivery system across the US following 510(k) regulatory clearance in December 2025. The update includes algorithm improvements to the closed-loop control system.
- 215TechnologySource · Mobi Health News
AccurKardia receives patent for AI-ECG cardiac amyloidosis detection
AccurKardia received a U.S. patent for an AI-powered system that detects cardiac amyloidosis from standard 12-lead ECGs. The machine learning technology addresses delayed diagnosis in a disease area where early detection is challenging, expanding the company's AI-ECG analytics pipeline.
- 216TechnologySource · Healthcare IT News
Microsoft partners with Mayo Clinic to develop frontier AI model for healthcare
Microsoft and Mayo Clinic announced a partnership to develop an advanced AI model for healthcare applications. The collaboration aims to leverage Mayo's clinical expertise and data with Microsoft's AI infrastructure to build tools that address healthcare workflows. Terms and specific use cases were not detailed.
- 217TechnologySource · Mobi Health News
Microsoft partners with Mayo Clinic to develop frontier AI model for healthcare
Microsoft and Mayo Clinic formed a partnership to develop a frontier AI model for healthcare applications. The model, owned by Mayo Clinic, will integrate the health system's de-identified clinical data and longitudinal insights with Microsoft's AI, engineering, and cloud infrastructure. The collaboration aims to advance AI capabilities in clinical settings by combining clinical expertise with technology infrastructure.
- 218RegulationSource · Medical Design & Outsourcing
FDA rules, regulations and resources for artificial intelligence in medical devices
The FDA has issued guidance on how artificial intelligence and machine learning in medical devices will be regulated. Manufacturers incorporating AI/ML into products must determine regulatory classification and whether the software itself requires separate oversight. The guidance clarifies FDA authority over both device hardware and software components.
- 219TechnologySource · Healthcare IT News
Beyond the screen: How ambient AI is changing the exam room
Beth Israel Lahey Health is implementing ambient AI in exam rooms to reduce physician documentation burden and improve patient engagement. The technology captures and processes clinical conversations without requiring clinicians to maintain eye contact with computer screens during appointments, allowing providers to focus more directly on patients while EHR data is populated automatically in the background.
- 220TechnologySource · Healthcare IT News
New HSCC guide addresses cybersecurity risks specific to healthcare AI
The Healthcare and Public Health Sector Coordinating Council has released new guidance on cybersecurity risks specific to healthcare AI systems. The guide addresses governance and security considerations as providers increasingly deploy AI across clinical and operational workflows, going beyond existing regulatory requirements to help organizations establish effective AI cybersecurity practices.
- 221New productsSource · Medical Device Network
HeartBeam reports positive ECG data in heart attack detection
HeartBeam reported positive study data supporting an indication expansion of its ECG device into heart attack detection. The data advance the scientific foundation for the company's planned product expansion, though specific clinical endpoints and timeline for regulatory submission were not detailed in the announcement.
- 222New productsSource · Medical Device Network
Stryker introduces TPX HD small bone power tool for orthopaedic surgery
Stryker launched TPX HD, a small bone power tool designed for orthopaedic procedures including total joint revisions, minimally invasive surgery, and oral maxillofacial operations. The tool expands Stryker's surgical instrument portfolio for complex bone work.
- 223RegulationSource · Medical Device Network
Philips secures FDA clearance for Elevate Plus AI ultrasound upgrade
Philips received FDA 510(k) clearance for Elevate Plus, a software upgrade that adds imaging and AI capabilities to its EPIQ Elite and Affiniti ultrasound systems. The clearance enables the company to deploy enhanced diagnostic features across its installed base of ultrasound platforms.
- 224MarketSource · MedCity News
Novellia Snags $18M for Its Real-World Data Platform
Novellia raised $18 million in Series A funding to expand its real-world data platform, which enables patients to consolidate medical records and share anonymized data with pharmaceutical companies. The platform aims to improve drug research by sourcing more complete healthcare datasets directly from patient sources.
- 225MarketSource · Mobi Health News
Elation Health acquires Aster to expand AI-enabled EHR capabilities
Elation Health acquired Aster, an EHR startup focused on women's health, to expand its AI-enabled electronic health record capabilities. Elation, a California-based supplier of cloud-based clinical EHRs, telehealth services, and practice management software for primary care providers, added Aster's women's health specialization to its existing portfolio of digital tools for healthcare providers.
- 226New productsSource · Medical Design & Outsourcing
Can surgical robots fly? SSi’s CEO discusses the challenges and solutions
SS Innovations CEO Dr. Sudhir Srivastava outlined plans for a flying surgical robot, the Vimana Aero drone, targeting mid-2026 launch. The company unveiled a conceptual design in April and is working through engineering and regulatory challenges to develop an autonomous aerial platform for surgical applications.
- 227TechnologySource · Healthcare IT News
Epic integrates firearm injury risk screening tool from Northwell Health
Epic Systems has integrated a firearm injury risk screening tool developed by Northwell Health into its EHR platform. The tool enables clinicians to identify patients at elevated risk during clinical encounters. The integration expands access to the screening capability across Epic's user base of healthcare systems and providers.
- 228MarketSource · Medical Device Network
Subtle Medical raises $33m, appoints new CEO to advance AI image software
Subtle Medical closed a $33 million Series C funding round and appointed industry veteran Ohad Arazi as CEO to lead global commercialization of its AI imaging software. The company develops artificial-intelligence tools for medical image processing and analysis.
- 229RegulationSource · Medical Design & Outsourcing
FDA picks Nephrodite’s implantable dialysis system for TAP pilot
Nephrodite's Holly implantable continuous dialysis system has been selected for the FDA's Total Product Life Cycle Advisory Program (TAP) pilot. The device previously received FDA Breakthrough Device Designation. The TAP program is designed to expedite patient access to innovative medical devices through enhanced regulatory guidance and support.
- 230RegulationSource · Medical Device Network
Podcast: Assessing the EMA’s new innovative medical device pathway pilot
The European Medicines Agency has launched a pilot programme offering expert support to manufacturers developing breakthrough medical devices through a new innovative device pathway. The initiative is designed to streamline regulatory review and guidance for qualifying emerging technologies, potentially accelerating time to market for novel solutions.
- 231New productsSource · Medical Device Network
ASCO26: Abbott demonstrates MRD test benefit in TNBC recurrence
Abbott presented data from a prospective sub-study of the PARTNER trial at ASCO26, demonstrating the clinical utility of its MRD (minimal residual disease) test in predicting triple-negative breast cancer recurrence. The findings support the diagnostic value of Abbott's molecular assay in identifying patients at risk of recurrence following treatment.
- 232New productsSource · Medical Device Network
Made Scientific to manufacture NOVAKnee implant
Made Scientific will manufacture NOVAKnee, a biologic total knee replacement implant, for use in a Phase I clinical study in the US. The announcement signals progression of the device toward human trials, though specific clinical details and regulatory pathway remain unspecified in the source.
- 233New productsSource · Medical Device Network
MicroPort launches LBBOT Solution commercially in Europe and Australia
MicroPort CardioFlow has launched its LBBOT Solution commercially in Europe and Australia following regulatory approvals. The solution addresses left bundle branch block treatment, expanding the vendor's cardiac care portfolio in international markets.
- 234TechnologySource · Mobi Health News
SNUH, Harvard unveil world's first virtual hospital for validating medical AI
Seoul National University Hospital and Harvard Medical School have developed a virtual hospital framework for validating large language model-based medical AI. The Clinical Environment Simulator uses two synchronized core engines to dynamically evaluate medical AI systems, offering a standardized platform for testing AI-driven diagnostic and clinical decision-support tools before real-world deployment.
- 235TechnologySource · Mobi Health News
Epic integrates firearm injury risk screening tool from Northwell Health
Epic Systems has integrated a firearm injury risk screening tool developed by Northwell Health into its EHR platform. The tool, created through NIH-funded research, enables healthcare providers to screen patients for firearm injury risk and systematically collect data on firearm-injured patients within Epic workflows.
- 236New productsSource · Medical Design & Outsourcing
How Philips and Disney are improving children’s MRI experience
Philips has partnered with Disney to integrate Disney characters and storytelling into its Ambient Experience platform for pediatric MRI systems. The initiative, building on Philips' existing ambient experience technology from the early 2000s, aims to reduce anxiety and improve the scanning experience for child patients by embedding Mickey Mouse, Yoda, and other Disney IP into medical facility environments.
- 237MarketSource · Medical Device Network
Veritas Aortic Solutions raises $12m for aortic disease treatment advance
Veritas Aortic Solutions secured $12 million in funding to advance its technology for treating acute aortic root and ascending aorta pathologies without open heart surgery. The company is developing a minimally invasive approach to address aortic disease, positioning itself as an alternative to conventional surgical intervention.
- 238New productsSource · Medical Device Network
ASCO26: Data highlights test benefit in breast cancer treatment planning and earlier detection
Veracyte presented clinical data on its Prosigna genomic assay for breast cancer treatment planning at ASCO 2026, alongside findings from GRAIL's multi-cancer early detection test. The data highlighted the assays' utility in guiding therapy selection and enabling earlier cancer identification, supporting their role in precision oncology and screening workflows.
- 239RegulationSource · Medical Device Network
SHINE Technologies receives EU CMA for Ilumira Lu-177 radioisotope
SHINE Technologies obtained a Conditional Marketing Authorization (CMA) from European regulators for Ilumira, its Lu-177 radioisotope product. The clearance permits commercial distribution of the radiopharmaceutical across EU member states. Lu-177 is used in targeted radionuclide therapy for neuroendocrine tumors and other cancers.
- 240RegulationSource · Medical Device Network
SKIA secures FDA 510(k) clearance for AR surgical platform
SKIA, a South Korean medical technology company, received FDA 510(k) clearance for SKIA HEAD, an augmented reality surgical guidance system. The clearance enables the company to market the platform in the US for intraoperative visualization and navigation.