- 121TechnologySource · Medical Design & Outsourcing
Yale-led study finds wearable sensors match motion capture for gait tracking in knee osteoarthritis
Yale-led researchers demonstrated that foot-mounted wearable sensors can match motion-capture systems for gait tracking in knee osteoarthritis patients, according to findings published in JMIR Formative Research. The study, involving international collaborators, showed wearable sensors achieved near-equivalent accuracy in measuring walking speed and other gait parameters without requiring laboratory-grade motion-capture equipment, potentially enabling remote patient monitoring and home-based assessment.
- 122MarketSource · Medical Design & Outsourcing
Data breaches are killing more deals than anything else, these M&A lawyers say
M&A lawyers specializing in medical device companies report that data breaches are increasingly derailing acquisition and divestiture deals in the medtech sector. The commentary follows a year marked by significant consolidation activity and private-equity involvement among the world's largest device manufacturers, with cybersecurity risk now emerging as a critical deal-killer alongside traditional financial and operational due diligence factors.
- 123MarketSource · Medical Device Network
Everlywell and Waters team up for at-home HPV screening
Everlywell partnered with Waters Corporation to distribute the Onclarity HPV Self-Collection Kit, an at-home cervical cancer screening device. The kit uses the BD Onclarity HPV Assay for testing. The partnership expands patient access to at-home HPV screening options.
- 124RegulationSource · Medical Device Network
FDA clears Medtronic’s LigaSure RAS Maryland device
Medtronic received FDA clearance for the LigaSure RAS Maryland jaw device, designed for use with its Hugo robotic-assisted surgical system. The clearance expands the company's minimally invasive surgical portfolio.
- 125MarketSource · Medical Design & Outsourcing
UltiMaker and Bioactivx advance on-demand 3D-printed wound care
UltiMaker, a professional 3D printing vendor, has signed a memorandum of understanding with Bioactivx, a Singapore medtech startup, to develop on-demand 3D-printed wound care solutions. Bioactivx has received Health Sciences Authority approval for end-use medical implants, positioning the partnership to scale personalized wound care manufacturing.
- 126MarketSource · Medical Device Network
Evvy secures $40m to validate AI-based women’s health diagnostics
Evvy raised $40 million in Series B funding to advance its AI-powered diagnostic platform for women's health. The round was oversubscribed, marking a significant capital infusion for the company to validate its diagnostic models and expand its care offerings in the women's health sector.
- 127New productsSource · Medical Device Network
Hyperfine concludes Contrast PMR study enrolment for Swoop MRI system
Hyperfine announced completion of patient enrolment in its multi-centre Contrast PMR study evaluating contrast agents with its Swoop portable MRI system. The study completion marks progress toward expanded clinical applications for the point-of-care MRI device.
- 128TechnologySource · Medical Design & Outsourcing
Promex automates 3D inspection for rigid and flexible PCBs
Promex Industries announced automated 3D inspection technology for rigid and flexible PCB assemblies used in medical electronics. The system performs 100% inspection of circuit board components, detecting manufacturing variations as component density and complexity increase. The technology addresses quality control needs for high-reliability medical device applications.
- 129TechnologySource · Medical Device Network
Agentic AI trust gap slowing healthcare provider adoption, survey reveals
A survey by Imprivata reveals healthcare providers are hesitant to adopt agentic AI systems due to trust and governance concerns. The findings highlight that as healthcare organizations integrate autonomous AI agents into clinical workflows, establishing clear accountability frameworks and trust mechanisms has become critical to accelerating adoption.
- 130RegulationSource · Medical Device Network
Intuitive receives CE mark for transvaginal use of da Vinci SP system
Intuitive Surgical has obtained CE mark approval for transvaginal use of its da Vinci SP single-port robotic surgical system in gynecologic procedures. The clearance expands the approved applications for the platform in European markets.
- 131MarketSource · Medical Device Network
BRAINBox and Prolight sign supply agreement for concussion tests
BRAINBox Solutions has signed a supply agreement with Prolight Diagnostics to obtain Psyros instruments and cartridges for delivery of concussion diagnostic and prognostic tests in point-of-care settings. The partnership enables BRAINBox to expand distribution of its concussion assessment offering.
- 132MarketSource · Medical Device Network
Apollo rumoured to be eyeing $20bn takeover of J&J’s orthopaedics business
Apollo is reportedly in talks to acquire Johnson & Johnson's orthopaedics division, DePuy Synthes, in a deal valued around $20 billion. The acquisition would occur as part of J&J's planned spin-out of the orthopaedics unit. Terms and timeline remain unconfirmed.
- 133MarketSource · MedCity News
Inspiren Rakes In $70M to Scale Its AI-Powered Senior Living Platform
Inspiren, a developer of an AI-powered senior living platform that uses ambient sensors and computer vision to predict falls, closed a $70 million Series C funding round led by NewView Capital. The funding will support scaling of the platform's predictive fall-detection capabilities for senior care facilities.
- 134RegulationSource · MedCity News
Nutromics Nabs FDA Breakthrough Status for Antibiotic Monitoring Patch
Nutromics received FDA breakthrough device designation for a wearable patch that monitors vancomycin levels in real time, intended to eliminate periodic blood draws for antibiotic dosing. The designation accelerates the regulatory pathway for the continuous monitoring technology.
- 135RegulationSource · Medical Device Network
Nutromics’ drug monitoring patch secures FDA breakthrough designation
Nutromics has received FDA Breakthrough Device designation for its wearable drug-monitoring patch, which tracks vancomycin levels. The designation accelerates review pathways for the platform and signals FDA recognition of the technology's potential clinical value in therapeutic drug monitoring.
- 136MarketSource · Medical Device Network
Axogen deepens nerve repair portfolio through $200m BioCircuit takeover
Axogen acquired BioCircuit Technologies for $200 million to expand its peripheral nerve repair portfolio, adding NerveTape, a sutureless nerve repair device, to its product line. The deal aims to accelerate market adoption of the technology and strengthen Axogen's position in the nerve repair sector.
- 137MarketSource · Medical Device Network
Senphonix secures NSF grant for SleeveSense wearable development
Senphonix secured an NSF STTR Phase I grant to advance SleeveSense, a wearable vital signs monitoring platform. The funding supports continued development of the device, which monitors patient health metrics in a wearable form factor.
- 138RegulationSource · Medical Device Network
XCath secures FDA breakthrough designation for remote thrombectomy robot
XCath has received FDA Breakthrough Device designation for its remote thrombectomy robot system, which aims to expand access to stroke treatment. The designation supports continued development of the remote-operated surgical platform.
- 139RegulationSource · Medical Device Network
J&J’s new reusable contact lens secures CE Mark
Johnson & Johnson received CE Mark approval for ACUVUE OASYS MAX 2-Week, a reusable contact lens incorporating MAX technology. The clearance enables market distribution in Europe for the two-week wear modality.
- 140MarketSource · Medical Design & Outsourcing
Velosity acquires Lucid to expand medtech engineering capabilities
Velosity, a portfolio company of Graham Partners, has acquired Lucid to expand its engineering and innovation capabilities for medical device manufacturers. The acquisition strengthens Velosity's service offerings from concept development through full-scale production, complementing its existing clean room injection molding expertise and outsourced manufacturing operations.
- 141New productsSource · Medical Design & Outsourcing
This tissue engineering scientist is bioprinting next-gen absorbable implants
Dr. Claudia Chavez-Munoz, co-founder and Chief Scientific Officer of Conexeu Sciences, has developed a regenerative, bioabsorbable extracellular matrix (ECM) platform for personalized breast implants, burn wound care, and tissue restoration. The technology addresses limitations in existing acellular implant solutions and leverages bioprinting to enable customized implants across multiple surgical applications.
- 142New productsSource · Medical Design & Outsourcing
How Aerotech’s new cylinder-lasering machine speeds medical device production
Aerotech announced the LaserTurn280, a motion platform designed for high-volume laser machining of cylindrical medical-device components used in coronary stents, neurovascular stents, structural heart devices, peripheral vascular implants, and minimally invasive surgical instruments. The system was previously shown in prototype form at medical-technology trade shows.
- 143MarketSource · Medical Device Network
Siemens Healthineers completes $43.6m revamp of PET detector site in Tennessee
Siemens Healthineers completed a $43.6 million upgrade of its PET detector manufacturing facility in Rockford, Tennessee, the company's sole global production site for detectors used in its PET/CT imaging systems. The investment reflects capital commitment to domestic medical imaging equipment manufacturing.
- 144TechnologySource · MedCity News
Healthcare Executives Weigh In: AI Readiness and the Growing Risk of Cybersecurity Threats
A September 30 webinar will present findings from the 2026 Healthcare AI Readiness Index, addressing operational, regulatory, and security challenges tied to AI deployment in healthcare settings. The event targets healthcare executives and will explore cybersecurity risks alongside AI adoption trends relevant to medical-device and IT vendors navigating regulatory and operational shifts.
- 145New productsSource · Medical Device Network
Nightingale Health and Genom to launch risk detection test in Croatia
Nightingale Health and Genom have partnered to launch a blood-based risk detection test in Croatian clinics and laboratories. The test leverages biomarker analysis to identify disease risk in patient populations. The partnership expands Nightingale's diagnostic footprint in Central Europe through Genom's local laboratory network.
- 146RegulationSource · Medical Device Network
FDA grants 510(k) clearance to Emboliner system for TAVR procedures
Emboline received FDA 510(k) clearance for its Emboliner embolic protection system, designed for transcatheter aortic valve replacement (TAVR) and related cardiac procedures. The clearance enables the company to market the device in the US for use during these interventional cardiology procedures.
- 147MarketSource · Medical Design & Outsourcing
Ensurge relocates San Jose operations to advance microbattery development
Ensurge Micropower relocated its San Jose operations to a new facility to accelerate solid-state microbattery development and pilot-line capabilities. The move is expected to reduce facility overhead from 30% to 10% of monthly operating expenses, freeing resources for customer engagement and product advancement.
- 148MarketSource · Medical Device Network
DermaSensor completes $5m fundraise following new partnership quadruplet
DermaSensor completed a $5 million Series B funding round following the announcement of four new partnerships, including a supplier agreement with Henry Schein. The financing and partnerships expand the company's distribution and commercial reach in the dermatology equipment space.
- 149New productsSource · Medical Design & Outsourcing
Petal Surgical CEO Prash Chopra offers advice for device developers
Petal Surgical CEO Prash Chopra previewed the company's incisionless surgery system combining histotripsy ablation, robotics, and AI, ahead of an expected first-in-human procedure. The technology targets millimeter-scale tissue destruction without incisions, representing a potential shift in minimally invasive surgical approaches.
- 150RegulationSource · Medical Device Network
Abbott’s dual ablation catheter lands FDA approval
Abbott received FDA clearance for its TactiFlex Duo dual ablation catheter, following the device's CE mark approval in January 2026. The catheter enables physicians to perform both radiofrequency and cryoablation procedures using a single device, intended for cardiac arrhythmia treatment.
- 151New productsSource · Medical Device Network
restor3d introduces MyFit digital suite for orthopaedic care
restor3d launched MyFit, a digital platform designed to enhance patient engagement and visibility throughout orthopaedic care pathways. The suite targets orthopaedic care providers and patients seeking integrated care management and communication tools.
- 152MarketSource · Medical Device Network
Labcorp acquires MLM Medical Labs to expand global central lab network
Labcorp has acquired MLM Medical Labs to expand its global central laboratory network and biomarker testing capabilities for clinical studies. The deal strengthens Labcorp's service offerings in clinical trial support and laboratory diagnostics.
- 153New productsSource · Medical Design & Outsourcing
nPhase launches AI-native clinical data management platform
nPhase, a clinical research technology vendor, launched nPhase.AI, an AI-native enterprise platform for end-to-end clinical data management. The platform includes an agentic statistical computing environment designed to reduce time from raw study data to submission-ready outputs by 75% while requiring 80% fewer resources.
- 154TechnologySource · Medical Design & Outsourcing
Intracranial sensor maker says automated testing slashed firmware development time
Parasoft's automated testing platform helped Kitea Health accelerate firmware development for its investigational intracranial pressure (ICP) sensor used in hydrocephalus treatment. The automated approach reduced verification cycles for safety-critical code running on the device, shortening time-to-development for the medical sensor.
- 155MarketSource · MedCity News
Forus Secures $150M Series C, Reaches $3B Valuation
Forus, an AI-powered diagnostic imaging software company, raised $150 million in Series C funding led by Bain Capital Ventures, valuing the company at $3 billion. The round included participation from Thrive Capital, General Catalyst, Accel, Redpoint, and eight other venture firms.
- 156New productsSource · MedCity News
This Startup Wants to Make Glaucoma Surgery Recovery Easier
LEP Biomedical is developing a dissolvable implant designed to replace post-operative eye drops following glaucoma surgery. The device aims to improve patient compliance during recovery, addressing a significant driver of surgical failure rates that can reach 40%. The implant delivers medication over weeks without requiring patient self-administration.
- 157RegulationSource · Medical Design & Outsourcing
This de novo minimally invasive system was designed for safer hysterectomies
Claria Medical received FDA de novo classification in July 2026 for a minimally invasive hysterectomy system designed to reduce container breach rates and associated risks of cancer spread or bowel injury. The Mountain View, California-based company developed the device to address limitations in current surgical approaches for one of the most common gynecological procedures.
- 158MarketSource · Medical Device Network
OncoSil Medical secures funding for cancer device launch
OncoSil Medical has secured A$5.6 million ($4.03 million) in funding commitments to support the launch of its single-use brachytherapy device for cancer treatment. The capital raise will enable commercialization of the device.
- 159MarketSource · Medical Device Network
Boston Scientific on road to recovery following cyberattack
Boston Scientific experienced a cyberattack on August 25 that disrupted global operations. The company is now in recovery mode following the incident. No details on impact scope, systems affected, or timeline to full restoration were provided.
- 160New productsSource · Medical Device Network
Nyxoah implants first patient in BREATHE study of Genio
Nyxoah, a Belgium-based medical device company, has implanted the first patient in its BREATHE post-approval study of the Genio system for obstructive sleep apnea. The Genio is an implantable neurostimulation device designed to treat OSA by stimulating the hypoglossal nerve.