- 041New productsSource · MedCity News
Datavant’s New Platform Could Cut Record Retrieval Time from Days to Hours
Datavant launched a provider exchange platform designed to digitize medical record requests, replacing traditional fax-based workflows. The system provides real-time visibility into request status and reduces administrative burden on clinical staff by accelerating retrieval from days to hours.
- 042RegulationSource · Medical Device Network
NICE recommends NHS funding for Bridge to Life’s liver perfusion system
The UK's National Institute for Health and Care Excellence (NICE) recommended NHS funding for Bridge to Life's VitaSmart liver perfusion system, one of four devices approved for routine coverage. The recommendation signals market access and reimbursement pathway clearance for the organ perfusion technology in the UK healthcare system.
- 043RegulationSource · Medical Device Network
Paradromics gets FDA nod for broader BCI device compatibility
Paradromics received FDA approval to expand compatibility of its investigational brain-computer interface (BCI) system with a broader range of personal computing devices. The clearance widens the potential integration options for the BCI platform, allowing it to work with more standard consumer and enterprise computing hardware.
- 044MarketSource · Medical Device Network
Boston Scientific impacted by ongoing cyberattack
Boston Scientific disclosed a cyberattack discovered on 25 August that has caused global operational disruptions. The incident affects the medical device supplier's IT systems and poses supply-chain risks to customers and distributors relying on the company's ordering, fulfillment, and support infrastructure.
- 045MarketSource · Medical Device Network
PENTAX broadens MAGENTIQ EYE partnership for global AI colonoscopy
PENTAX Medical has expanded its partnership with MAGENTIQ EYE to accelerate global deployment of AI-assisted colonoscopy technology. The collaboration aims to increase adoption of AI-enabled diagnostic capabilities across PENTAX's endoscopy portfolio in international markets.
- 046MarketSource · MedCity News
Onos Health Raises $17M to Expand AI-Powered Behavioral Health Platform
Onos Health closed a $17M Series A funding round led by Costanoa, with participation from Flare Capital Partners and CVS Health Ventures. The funding will support expansion of the company's AI-powered behavioral health platform.
- 047TechnologySource · Medical Design & Outsourcing
This researcher’s development could inspire new and next-gen neuromod technologies
Dr. Stavros Zanos and researchers at Northwell Health's Feinstein Institutes completed a comprehensive human vagus nerve anatomical map designed to inform development of next-generation neuromodulation therapies. The detailed mapping of vagus nerve anatomy could enable more precise and safer device targeting for autonomic nervous system modulation in heart rate, breathing, digestion, and immune function.
- 048MarketSource · MedCity News
Cyberattack Disrupts Boston Scientific’s Operations: 7 Things to Know
Boston Scientific disclosed a cyberattack affecting its global IT systems and order-fulfillment capabilities, with no timeline given for service restoration. The incident marks the latest major breach to hit a tier-one medtech vendor in 2026, following similar attacks on Stryker, Medtronic, and Abbott. Supply chain disruptions and operational impacts remain uncertain pending system recovery.
- 049TechnologySource · Medical Device Network
ESC 2026: AI able to detect diabetes from facial video recordings
Researchers from the University of Tokyo and Institute of Science Tokyo have developed an AI system that detects diabetes from facial video recordings with over 80% accuracy using clips as short as 5 to 30 seconds. The technology was presented at ESC 2026, demonstrating potential for non-invasive screening applications.
- 050RegulationSource · Medical Device Network
FDA approves Abbott’s Libre Duo 10 Day dual glucose-ketone monitor
Abbott received FDA authorization for the Libre Duo 10 Day, a continuous glucose and ketone monitoring system. The device is designed for people with diabetes and claims to be the first to simultaneously track both glucose and ketone levels in a single wearable monitor.
- 051MarketSource · Medical Device Network
Hike Medical raises $22.5m to advance medical equipment supply provision
Hike Medical secured $22.5 million in funding to enhance its platform for clinician ordering workflows in durable medical equipment and orthotics supply. The capital will support technology development aimed at accelerating patient delivery timelines in the DME and orthotic space.
- 052New productsSource · Medical Device Network
Axoft launches Fleuron WISE polymer for advanced biological imaging
Axoft has launched Fleuron WISE, a polymer designed to reduce optical distortions during high-resolution imaging of aqueous biological samples. The material targets improved image quality in microscopy and diagnostic imaging applications where sample clarity is critical.
- 053RegulationSource · Medical Device Network
Avulux lands FDA de novo classification for light-sensitive migraine lenses
Avulux received FDA de novo classification for its light-filtering lens technology designed for light-sensitive migraine sufferers. The lenses block up to 97% of blue, amber, and red light wavelengths while transmitting green light. De novo classification establishes a new regulatory pathway for the device type.
- 054RegulationSource · Medical Device Network
Guardant ordered to pay $245m in DNA sequencing patent dispute
Guardant Health was ordered to pay $245 million in a patent dispute over DNA sequencing technology. The ruling includes a 6% ongoing royalties obligation that the company plans to appeal. The case concerns intellectual property rights related to sequencing methods used in the company's diagnostic platforms.
- 055New productsSource · Medical Device Network
Medical Guardian unveils Guardian Flex wearable for older adults
Medical Guardian launched Guardian Flex, a wearable device designed for older adults that provides emergency alert capabilities. The product integrates into daily routines and targets the aging population seeking personal safety and emergency response solutions.
- 056MarketSource · Medical Device Network
IceCure and Scovas agree for ProSense distribution in Netherlands
IceCure Medical has signed an exclusive distribution agreement with Scovas Medical to supply ProSense cryoablation systems in the Netherlands. The deal expands IceCure's market reach in the region through a specialized distributor partner.
- 057MarketSource · Medical Design & Outsourcing
What private equity means for medtech OEMs, suppliers and their employees
Private equity investment in medical device manufacturers and suppliers is accelerating as investors seek higher returns than public markets offer. The trend affects OEM profitability, operational strategy, and workforce dynamics across the medtech supply chain, reshaping vendor consolidation and competitive positioning.
- 058MarketSource · Medical Design & Outsourcing
Smith+Nephew to partner with Imperial College London for robotic surgery research center
Smith+Nephew announced a five-year partnership with Imperial College London to establish a research center focused on musculoskeletal robotic surgery. The collaboration will combine the company's expertise with academic research to co-develop new robotic surgical solutions, marking the first such partnership for both organizations in this domain.
- 059RegulationSource · Medical Device Network
Roche’s pTau217 single-biomarker Alzheimer’s blood test lands FDA approval
Roche's pTau217 blood test for Alzheimer's disease received FDA clearance, following CE mark approval in Europe in May 2026. The single-biomarker assay detects phosphorylated tau-217, a protein associated with Alzheimer's pathology, enabling blood-based diagnostic screening without requiring imaging or lumbar puncture.
- 060RegulationSource · Medical Device Network
Implantica’s anti-reflux device secures FDA approval to tee up J&J rivalry
Implantica's RefluxStop, an implantable anti-reflux device for gastroesophageal reflux disease, has secured FDA approval in the United States. The device previously received CE marking in Europe in 2018 and has been implanted in approximately 1,800 patients. The approval positions Implantica to compete in a market segment where Johnson & Johnson holds existing offerings.
- 061RegulationSource · Medical Device Network
Pulnovo Medical enrols first US patients in PULSE-LHD IDE trial
Pulnovo Medical has enrolled the first US patients in the PULSE-LHD IDE (Investigational Device Exemption) trial, evaluating PADN (pulmonary artery denervation) therapy for pulmonary hypertension with left heart disease. The trial represents a regulatory milestone for the device candidate in the US market.
- 062MarketSource · Medical Device Network
Shape Memory Medical secures $10m to advance aortic clinical trials
Shape Memory Medical closed a $10 million funding round led by August Global Partners to advance clinical trials for its aortic device portfolio. The financing supports the company's development of cardiovascular interventions targeting aortic pathology.
- 063TechnologySource · MedCity News
This Week In Epic News: FTC Probe, AI Agents & More
Epic Systems announced new AI tools at its annual conference while facing an FTC antitrust investigation. The EHR vendor's AI agent initiatives represent a significant technology shift in clinical software capabilities, though details on specific tools remain limited in available reporting.
- 064New productsSource · Medical Design & Outsourcing
Engineers create smart ring that tracks biomarkers in finger sweat
Researchers at UC San Diego developed a wearable smart ring that uses finger sweat to monitor six biomarkers: glucose, ketones, vitamin C, uric acid, lactate, and alcohol. The device employs an osmotic hydrogel to extract and analyze sweat composition, with findings published in Nature Communications. The technology represents a new class of non-invasive continuous monitoring wearable for personal health tracking.
- 065New productsSource · Medical Design & Outsourcing
A continuous monitoring medtech vet charts the course to a less-invasive future
BD has launched the HemoSphere Stream Module, a noninvasive continuous blood pressure monitoring technology. Tim Patz, BD's Worldwide President of Advanced Patient Monitoring and former Edwards Lifesciences executive, led the product introduction. The technology reflects industry movement toward less-invasive patient monitoring solutions.
- 066TechnologySource · MedCity News
The Pulse of Innovation: How 3D Models Can Prepare Surgeons for the Operating Room
3D modeling and printing technology is being integrated into surgical preparation workflows to reduce operating time by 30–90 minutes per procedure. As the technology matures and becomes more widely adopted in clinical settings, further gains in surgical efficiency are expected.
- 067RegulationSource · Medical Device Network
FDA clears C2N Diagnostics’ early Alzheimer’s assessment test
The FDA has cleared C2N Diagnostics' Alzheimer's assessment test, marking the first FDA-cleared diagnostic for patients as young as 40 presenting with cognitive impairment symptoms. The clearance expands the addressable patient population for early Alzheimer's detection in clinical settings.
- 068MarketSource · Medical Device Network
Olympus-backed MaxQ Medical raises $31.5m for prostate care platform’s advancement
MaxQ Medical, backed by Olympus, raised $31.5 million to advance its integrated prostate care platform that combines imaging with tissue-selective therapy in a single transurethral procedure. The funding supports continued development and commercialization of the technology, which addresses minimally invasive treatment of benign prostatic hyperplasia and related conditions.
- 069MarketSource · Medical Device Network
Renata Medical raises $25m to advance paediatric stent system
Renata Medical raised $25 million in funding to advance Minima, a pediatric stent system designed for congenital heart defects in children. The capital will support continued development and commercialization of the device.
- 070New productsSource · Medical Device Network
Galmed’s Colospan completes feasibility study of colon tissue platform
Galmed subsidiary Colospan has completed a feasibility study of an intraoperative platform designed to assess colon tissue quality during surgical procedures. The technology represents a new diagnostic tool for real-time tissue evaluation in colorectal surgery.
- 071RegulationSource · Medical Device Network
FDA clears Empatica’s platform for Parkinson’s monitoring
Empatica received FDA 510(k) clearance for its Health Monitoring Platform for Parkinson's disease, enabling the company to offer clinical-grade remote monitoring for Parkinson's patients. The clearance expands Empatica's existing remote-monitoring technology into neurology care.
- 072MarketSource · MedCity News
Happy Health Snags $75M to Support Home-Based Care
Happy Health secured $75 million in funding from ARCH Venture Partners and OpenLoop to expand home-based care operations. The round supports the company's growth in delivering medical services and support to patients in home settings.
- 073MarketSource · Medical Device Network
Perimeter and Culturewell launch hospital infection surveillance programme
Perimeter and Culturewell have launched a joint hospital infection surveillance programme that combines room-level surface sampling with building-level wastewater sequencing. The partnership pairs each company's diagnostic and monitoring capabilities to offer hospitals integrated pathogen detection across environmental and waste streams.
- 074RegulationSource · Medical Device Network
FDA seeks input on proposed regulatory approach to GenAI-based medtech
The FDA has opened a public comment period through October 2026 on its proposed regulatory framework for generative AI-based medical devices. The agency is seeking input from stakeholders on how to govern AI-enabled medtech while maintaining safety and efficacy standards.
- 075RegulationSource · Medical Device Network
Masimo’s brain function monitor secures CE mark
Masimo, a Danaher subsidiary, obtained CE mark approval for its smartSedLine brain function monitor, a device designed to support anaesthetic management. The clearance enables the company to market the monitor in European Union member states and other regions that recognise CE certification.
- 076RegulationSource · Medical Device Network
First patient treated in FDA IDE study of Aqua Medical’s PIMA device
Aqua Medical has enrolled the first West Coast patient in RESTORE-I, an FDA-approved investigational device exemption (IDE) study evaluating its PIMA procedure for type 2 diabetes treatment in adults. The trial represents advancement of the device through the FDA's clinical investigation pathway.
- 077MarketSource · Medical Device Network
Happy Health raises $75m for continuous healthcare platform’s expansion
Happy Health, whose smart ring received FDA clearance in September 2024 for obstructive sleep apnea diagnosis, has raised $75 million to expand its continuous healthcare platform. The funding will support broader development and commercialization of the wearable device and related analytics capabilities.
- 078TechnologySource · MedCity News
Rural US Healthcare Has A Cybersecurity Problem — CMS Funding Can Help Fix the Part No One Sees
Rural US hospitals face significant cybersecurity challenges, including gaps in staff training, backup systems, downtime procedures, and incident response protocols. CMS funding initiatives aim to address these infrastructure and operational deficiencies by providing frameworks that help organize security efforts and enable measurable progress, though implementation requires sustained investment in personnel and process development.
- 079New productsSource · Medical Design & Outsourcing
Device scan: Look inside a Medtronic PillCam with an industrial X-ray CT scanner
Lumafield used industrial X-ray CT scanning to provide a detailed internal examination of Medtronic's PillCam capsule endoscope, a swallowable diagnostic device used to visualize portions of the digestive tract unreachable by traditional endoscopy and colonoscopy since its 2001 introduction by Given Imaging.
- 080MarketSource · Medical Design & Outsourcing
Qosina launches regulatory services for device developers and manufacturers
Qosina, a medical device component supplier, has launched regulatory services for device developers and manufacturers. The new offering addresses compliance challenges arising from unexpected supply chain changes and material substitutions, according to CEO Lee Pochter. The service expands Qosina's traditional role as a supplier into consulting and regulatory support.