- 121MarketSource · MedCity News
IKS Health Acquires ARAI to Build Out Specialized AI Stack
IKS Health has acquired healthcare AI startup ARAI to expand its automation technology capabilities and reduce reliance on third-party AI models. The acquisition strengthens IKS Health's proprietary AI infrastructure for its automation tools used across healthcare operations.
- 122TechnologySource · Healthcare IT News
Changing assault-based STI outcomes with remote care delivery
Visby Medical has partnered with RAINN's Safe Access Program to deliver remote STI care for patients in underserved areas. The initiative enables patients with chlamydia, gonorrhea, and trichomoniasis to access medication without in-person appointments, addressing care gaps for sexual assault survivors who face access barriers or extended wait times.
- 123TechnologySource · Healthcare IT News
How one rural health system is designing targeted AI pilots to ease care delivery pressures
Berkshire Health Systems, a rural Massachusetts health system operating three hospitals and multiple care sites, is designing targeted AI pilots to address operational pressures including rising costs and staffing strain. The CIO emphasizes that technology deployment must be outcome-focused rather than technology-driven.
- 124MarketSource · Mobi Health News
9amHealth raises $26M for virtual specialty care platform and more funding news
9amHealth, a virtual specialty care platform focused on cardiometabolic health, closed a $26 million Series B round led by Define Ventures, with participation from SemperVirens, Catalio Capital Management, and NewHealth Ventures. The funding will support platform growth and enhancement. Define Ventures' founder will join the board.
- 125TechnologySource · MedCity News
Private Voice AI in Healthcare: How to Capture Critical Conversations Without Letting Patient Data Leave the Building
Healthcare organizations are deploying voice AI systems on their own infrastructure to capture and analyze clinical conversations while keeping patient data on-premises. The approach addresses privacy and security concerns by avoiding cloud-based processing, enabling teams to extract insights from voice records without transmitting sensitive information outside the organization.
- 126RegulationSource · Medical Device Network
FDA clears Glooko’s cloud-based insulin dosing platform
The FDA has cleared Glooko's cloud-based insulin dosing platform, a cloud-enabled version of its EndoTool system designed to support broader deployment across hospital settings. The platform enables scalable insulin management across healthcare facilities.
- 127RegulationSource · Mobi Health News
Malaysia OKs Korean AI for sepsis prediction and more AI briefs
AITRICS, a South Korean company, received Class C medical device approval from Malaysia's Medical Device Authority for AITRICS-VC (VitalCare), an AI software that analyzes hospital electronic medical record data to predict patient deterioration and identify sepsis risk. The tool is designed to support faster clinical decision-making and intervention.
- 128MarketSource · Medical Device Network
Butterfly Medical raises $21m in funds for BPH device development
Butterfly Medical closed a $21 million Series C funding round to advance development and commercialization of its minimally invasive benign prostatic hyperplasia (BPH) treatment device. The funding supports the company's effort to bring the urology-focused technology to market.
- 129MarketSource · Medical Device Network
BlueWind Medical raises $47.8m to advance commercialisation efforts for UUI treatment
BlueWind Medical closed a $47.8 million funding round to accelerate commercialisation of its Revi implantable tibial neuromodulation system for urge urinary incontinence treatment. Proceeds will fund expanded sales operations and market access initiatives.
- 130MarketSource · Medical Device Network
Ardent Health and Fujifilm team up for Synapse enterprise imaging rollout
Ardent Health, an acute care hospital operator across six US states, has partnered with Fujifilm Healthcare to deploy Synapse enterprise imaging solutions across its facilities. Synapse is an enterprise platform for managing medical imaging data and workflows across health systems.
- 131MarketSource · Medical Design & Outsourcing
Tecomet and Orchid complete merger, form global platform
Tecomet and Orchid Orthopedic Solutions completed their merger, creating a scaled global manufacturing platform. The combination is positioned to strengthen technical capabilities, expand global footprint, and improve supply resilience for OEM customers across medical device manufacturing.
- 132MarketSource · MedCity News
Shyld AI Snags $13M for Device that Disinfects Hospital Rooms Autonomously
Shyld AI raised $13.4 million to expand its AI-powered UV disinfection platform that autonomously sanitizes hospital rooms. The technology targets reduction of hospital-acquired infections and reduces dependence on manual cleaning labor.
- 133New productsSource · Mobi Health News
Dexcom unveils next-generation G8 CGM for real-time glucose monitoring
Dexcom announced the G8, a next-generation continuous glucose monitoring system during its Investor Day. CEO Jake Leach characterized the device as a completely new product platform, building on the company's existing CGM portfolio for real-time glucose tracking.
- 134New productsSource · MedCity News
Carrot Expands AI Metabolic Health Program to Menopause
Carrot expanded its AI-powered metabolic health platform to include menopause care, integrating personalized guidance with wearable device connectivity. The expansion extends the vendor's existing metabolic health offering into a new clinical area.
- 135MarketSource · Medical Device Network
UroMems eyes regulatory filings for SUI treatment after $60m fundraise
UroMems raised $60 million in funding to advance its UroActive system toward regulatory submission for stress urinary incontinence treatment. The company plans to use the capital to complete a pivotal trial supporting FDA and CE mark applications in the US and Europe.
- 136RegulationSource · Medical Device Network
AngioDynamics reports PRESERVE trial results for NanoKnife system
AngioDynamics released two-year data from its PRESERVE pivotal trial demonstrating durable outcomes for the NanoKnife irreversible electroporation (IRE) system in intermediate-risk prostate cancer treatment. The trial results support the clinical profile of the device and may inform future regulatory submissions or label claims for the platform.
- 137RegulationSource · Medical Device Network
Revvity secures FDA clearance for total testosterone immunoassay
Revvity received FDA clearance for a total testosterone automated chemiluminescence immunoassay (ChLIA) through its Immunodiagnostic Systems subsidiary. The assay is designed for automated clinical laboratory testing of testosterone levels.
- 138MarketSource · Medical Device Network
Rivermark pockets $20m in Series D for late-stage prostate device trial
Rivermark Medical raised $20 million in Series D funding to advance its pivotal trial for FloStent, a device designed to treat benign prostatic hyperplasia. The capital will support late-stage clinical development of the minimally invasive urology device.
- 139MarketSource · Medical Design & Outsourcing
Velosity launches innovation lab in Minnesota
Velosity opened a 5,000 sq ft innovation lab at its Brooklyn Park, Minnesota machining center of excellence, a multi-million-dollar facility that began development in September. The lab supports Velosity's contract manufacturing and product development capabilities for medical device makers.
- 140New productsSource · Medical Device Network
J&J launches Shockwave C2 Aero catheter for calcified CAD treatment
Johnson & Johnson launched the Shockwave C2 Aero coronary intravascular lithotripsy (IVL) catheter globally for treatment of calcified coronary artery disease. The device is designed to address calcium buildup in coronary vessels, expanding J&J's interventional cardiology portfolio.
- 141RegulationSource · Medical Device Network
Roche’s Elecsys pTau217 blood test secures CE mark for Alzheimer’s
Roche obtained CE mark for Elecsys pTau217, a blood-based diagnostic test co-developed with Eli Lilly to detect Alzheimer's disease pathology. The test measures phosphorylated tau-217, a biomarker associated with amyloid pathology in the brain, enabling earlier identification of disease in at-risk populations.
- 142TechnologySource · Healthcare IT News
NHG senior centres to deliver telehealth with 5G
NHG Health will deploy Singtel's 5G+ Priority SIM cards across 40 community health posts in senior centres across Central and North Singapore by end-2027 to support more reliable teleconsultations. The infrastructure upgrade aims to enhance telehealth connectivity for elderly residents and other community members, addressing reliability gaps in remote care delivery.
- 143RegulationSource · Medical Design & Outsourcing
Lessons learned and FDA TAP tips from a breakthrough device developer
Sentante, developer of a remote endovascular robotics system, was accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) in February 2026 following Breakthrough Device designation. The company shared insights on navigating the FDA's expedited regulatory pathway for novel medical devices.
- 144New productsSource · Mobi Health News
WHOOP launches clinician video visits, EHR integration with HealthEx
WHOOP, a wearable fitness company, launched AI-enabled features including on-demand video consultations with licensed clinicians for U.S. users and EHR integration via partnership with HealthEx. The additions extend WHOOP's platform beyond fitness tracking into clinical advisory services and healthcare system interoperability.
- 145RegulationSource · Medical Device Network
Bayesian Health secures first FDA clearance for AI-driven continuous sepsis monitor
Bayesian Health received FDA 510(k) clearance for an AI-driven continuous sepsis monitoring system, marking the first FDA approval for this type of early detection technology. The device uses artificial intelligence to identify sepsis indicators in real-time, enabling earlier clinical intervention in intensive care settings.
- 146RegulationSource · Medical Device Network
Biozen secures FDA 510(k) clearance for BP1000 device
Biozen received FDA 510(k) clearance for the BP1000, a cuffless blood pressure measurement device that performs spot readings from the fingertip without calibration. The clearance enables the company to market the device in the US.
- 147TechnologySource · MedCity News
How Beth Israel Lahey Health Cut Fax Failures From 34% to 4% — and Saved $4 Million
Beth Israel Lahey Health reduced fax failure rates from 34% to 4% and saved $4 million by adopting Retarus' cloud-based fax platform during an Epic EHR consolidation. The modernization simplified referral and prescription processing while reducing manual administrative work across the health system.
- 148TechnologySource · Mobi Health News
Volatile digital health marketplace impacts interoperability adoption
Market volatility in digital health is affecting the pace and scope of interoperability adoption among healthcare vendors and providers. Economic uncertainty, funding challenges, and shifting vendor priorities are slowing standardization efforts and integration initiatives that enable data exchange across platforms and systems.
- 149MarketSource · Medical Design & Outsourcing
Nissha breaks ground on manufacturing expansion in Wisconsin
Nissha Medical Technologies, the medical devices unit of Japan's Nissha Co., broke ground on a new 50,000-square-foot manufacturing facility in New Richmond, Wisconsin. The expansion targets its micro molding operations to increase capacity for miniaturized, precision-molded components in response to growing demand.
- 150TechnologySource · Healthcare IT News
Vendor Notebook: Health AI bolstered by collective approaches to quality
Viz AI and InterSystems partnered with the National Rural Health Association to advance rural care coordination through governance and workflow automation. Separately, Credo AI, Zyter|TruCare, and Infinitus Systems announced new tools to ensure quality, reliability, and output control for agentic AI systems. The moves reflect industry focus on assuring clinical safety and compliance as AI adoption in healthcare accelerates.
- 151New productsSource · Medical Design & Outsourcing
Mayo Clinic is using this device startup’s new system ‘like an induction cooktop’ to kill cancer
Mayo Clinic has installed a new electromagnetic induction system (EIS) developed by device startup New Phase to treat cancer using controlled magnetic hyperthermia. The system, installed in November 2025, treated its first U.S. patient in December as part of New Phase's clinical trial. The technology uses magnetic nanoparticles to generate localized heat to target tumors.
- 152MarketSource · Medical Device Network
Latest foreign investment in UK highlights underserved potential of primary care technology
Doctolib, a European digital health supplier, has acquired Medicus, a UK-based NHS GP technology provider, as part of a broader expansion strategy in the UK market. The deal underscores growing investor interest in primary care technology infrastructure.
- 153TechnologySource · MedCity News
Building a Unified Identity Strategy so Interoperability for Value-Based Care Can Succeed
Verato is hosting a May 27 webinar on unified identity strategy for healthcare interoperability in value-based care settings. The session will cover patient and provider identity management across systems and how identity infrastructure supports accurate attribution and data exchange needed for VBC models.
- 154RegulationSource · Medical Device Network
Alpha Tau concludes patient enrolment in ReSTART pivotal trial
Alpha Tau Medical has completed patient enrollment in its ReSTART pivotal trial, which evaluates Alpha DaRT for treating recurrent cutaneous squamous cell carcinoma (cSCC). The trial is a key milestone toward potential regulatory clearance of the device.
- 155New productsSource · Mobi Health News
Google unveils screenless Fitbit Air, new Google Health app
Google announced the Fitbit Air, a screenless wearable device for continuous health monitoring that tracks heart rate, sleep stages, blood oxygen, skin temperature, heart rate variability, and irregular heart rhythms including atrial fibrillation detection. The device will integrate with a new Google Health app that consolidates Fitbit and Pixel Watch data across Android and iOS platforms.
- 156MarketSource · Mobi Health News
Omada Health reports 42% revenue growth in Q1 2026 earnings
Omada Health, a San Francisco-based virtual care platform specializing in chronic disease management for diabetes, cardiometabolic conditions, hypertension, and musculoskeletal disorders, reported 42% year-over-year revenue growth in Q1 2026, one year after its NASDAQ debut. The company delivers behavior-change coaching and health tracking capabilities to its user base.
- 157TechnologySource · Healthcare IT News
Urgent care clinics boost revenue and throughput with AI scribe
Urgent care clinics are adopting AI scribe technology to automate clinical documentation during patient visits. The shift addresses a long-standing workflow challenge where providers spent significant time typing and navigating EHR systems during consultations, reducing patient interaction time. AI scribes capture visit details automatically, allowing clinicians to focus on direct patient engagement while improving documentation accuracy and compliance.
- 158TechnologySource · Healthcare IT News
Abridge releases ambient AI tech for nurses
Abridge announced its ambient AI documentation platform is now available to nurses across all its health system clients nationwide. The technology automates clinical documentation during patient encounters, reducing administrative workload and allowing nursing staff to focus more directly on patient care.
- 159RegulationSource · Medical Device Network
FDA clears Bright Uro’s abdominal sensor for evaluating bladder dysfunction
The FDA cleared Bright Uro's Glean abdominal sensor for evaluating bladder dysfunction. The sensor expands the capabilities of Bright Uro's Glean urodynamics system, which received FDA approval in March 2025. The abdominal sensor component enables non-invasive measurement of abdominal pressure during urodynamic testing.
- 160RegulationSource · Medical Device Network
FDA greenlights Rivanna’s AI musculoskeletal imaging system
The FDA has cleared Rivanna's Accuro XV system, an AI-enabled musculoskeletal imaging platform. The company plans to accelerate development of additional AI capabilities for the system following the clearance.