- 081MarketSource · Medical Device Network
4DMedical and Azra AI join forces to advance lung care pathways
4DMedical and Azra AI have formed a partnership to provide integrated lung care management solutions for health institutions. The collaboration combines 4DMedical's imaging technology with Azra AI's diagnostic software to enable end-to-end lung disease detection and monitoring across clinical workflows.
- 082New productsSource · Medical Device Network
University of Illinois researchers develop dialysis device
Researchers at University of Illinois Urbana-Champaign have developed a wearable device designed to detect early signs of dialysis access point failure. The technology aims to alert patients and clinicians to potential complications before they become critical, reducing unplanned dialysis interruptions and improving vascular access management.
- 083RegulationSource · Medical Device Network
J&J secures FDA clearance for MONARCH QUEST 3 bronchoscopy system
Johnson & Johnson received FDA 510(k) clearance for the MONARCH QUEST 3 bronchoscopy system, a navigational bronchoscopy platform designed for pulmonary diagnosis and intervention. The clearance enables the company to market the device in the US.
- 084RegulationSource · Medical Design & Outsourcing
J&J’s robotics and digital R&D head offers advice for device developers
Johnson & Johnson MedTech's Ottava surgical robotics system has received FDA de novo authorization. The company's Global Head of Robotics & Digital R&D shared insights on the product development process and regulatory pathway, offering guidance for other device developers navigating similar clearance challenges.
- 085RegulationSource · Medical Device Network
OncoSil obtains FDA humanitarian exemption for bile duct cancer treatment
OncoSil received FDA humanitarian exemption for its device designed to treat bile duct cancer. The implantable device is delivered directly into solid tumors via injection under endoscopic ultrasound guidance, enabling treatment of patients with this rare cancer type.
- 086RegulationSource · Medical Device Network
Lantheus Holdings’ Alzheimer’s radiodiagnostic secures FDA approval
Lantheus Holdings received FDA approval for a radiodiagnostic agent designed to identify cognitive impairment associated with tau neurofibrillary tangle pathology in Alzheimer's disease. The diagnostic imaging agent enables visualization and detection of tau pathology in patients with cognitive decline.
- 087RegulationSource · Medical Device Network
FDA selects Cadence’s HypertensionOS as second TEMPO pilot participant
The FDA has selected Cadence's HypertensionOS software as the second participant in its TEMPO (Total Product Life Cycle Advisory for Digital Health Devices) Pilot program. TEMPO provides premarket guidance and accelerated pathways for digital health devices, signaling regulatory momentum for software-based cardiovascular management tools.
- 088New productsSource · Medical Device Network
Nanochon secures Panamá’s approval for trial of knee cartilage implant
Nanochon has received approval from Panama's Ministry of Health to initiate a first-in-human clinical trial of its Chondrograft implant, a knee cartilage device. The trial represents an early-stage advancement for the company's regenerative orthopedic technology, marking progression toward potential commercialization in the region.
- 089RegulationSource · Medical Device Network
Samsung enters OTC hearing aid space with FDA clearance for Galaxy earbud feature
Samsung received FDA clearance for a hearing aid feature in its Galaxy Buds, enabling the company to compete in the over-the-counter hearing aid market alongside Apple's AirPods. The clearance marks Samsung's entry into a newly accessible medical device category.
- 090MarketSource · Medical Device Network
Olympus strikes global distribution agreement for Endocision’s cryocatheter
Olympus has signed a global distribution agreement for Endocision's cryocatheter, with commercial launch planned in the US, Canada, and Europe starting in early 2027. The deal expands Olympus's portfolio in minimally invasive surgical tools and represents a significant partnership in the cryotherapy device space.
- 091RegulationSource · Medical Device Network
Distalmotion receives FDA 510(k) clearance for Dexter robotic system
Distalmotion received FDA 510(k) clearance for its Dexter robotic surgery system, enabling the platform for ventral hernia repair procedures. The clearance expands the company's market access for robotic-assisted surgical applications.
- 092TechnologySource · Medical Device Network
Optellum and Coreline Soft plan AI integration for lung nodule care
Optellum and Coreline Soft announced a partnership to integrate artificial intelligence capabilities for lung nodule detection and management, targeting multiple international markets. The integration aims to combine both companies' platforms to enhance clinical workflows in pulmonary screening and follow-up care.
- 093New productsSource · Medical Design & Outsourcing
Bal Seal validates SP400HT medical seal material biosecurity
Bal Seal Engineering announced that its SP400HT PTFE sealing material has completed biocompatibility validation to ISO 10993-5 and USP Plastic Class VI standards, as tested by independent lab NAMSA. The material expands the company's portfolio of medical-grade sealing solutions for OEM device manufacturers.
- 094MarketSource · Medical Design & Outsourcing
Zeus plans new catheter manufacturing facility in Costa Rica
Zeus has leased a new catheter manufacturing facility for its CathX Medical subsidiary in Costa Rica's La Lima Free Zone. The expansion supports long-term customer demand as programs transition from development to commercialization, according to CEO Paddy O'Brien.
- 095TechnologySource · Medical Design & Outsourcing
The hardware gap is why legacy medical devices struggle with modern connectivity
Medical device manufacturers face mounting pressure to retrofit legacy equipment with IoT connectivity to meet regulatory requirements and hospital demands, but devices designed 5–15 years ago lack the hardware architecture to support modern connectivity standards. The industry gap between aging device designs and contemporary interoperability expectations is forcing suppliers to reconsider product roadmaps and upgrade strategies.
- 096RegulationSource · Medical Device Network
FDA clears Vesalio’s latest mechanical thrombectomy device
The FDA cleared Vesalio's pVasc NET, a mechanical thrombectomy device designed to capture and retain clot fragments during retrieval procedures. The device integrates clot-capture technology to improve safety and efficacy in thrombectomy interventions.
- 097RegulationSource · Medical Device Network
Freenome’s lung cancer test receives FDA breakthrough status
Freenome received FDA breakthrough device designation for SimpleScreen Lung, a blood-based test for lung cancer screening in adults. Breakthrough status expedites review of devices that address unmet medical needs and offer potential advantages over existing alternatives.
- 098RegulationSource · Medical Device Network
Wandercraft’s self-balancing exoskeleton wins FDA clearance
Wandercraft received FDA clearance for its self-balancing exoskeleton designed to support upright movement in paralyzed patients. The company plans to launch the device in the US market in September 2026.
- 099New productsSource · Medical Device Network
Enrolment concludes in BD’s PREVENT trial of Phasix Mesh
BD has completed patient enrolment in the PREVENT clinical trial evaluating Phasix Mesh for prevention of incisional hernias. The trial's conclusion of the enrolment phase marks a step toward potential regulatory submissions and commercialization decisions for the resorbable mesh product.
- 100TechnologySource · MedCity News
New Startup Launches to Close the Bedside Communication Gap in Hospitals
The 1842 Fund launched Suvi Health, a startup developing an ambient AI platform that records bedside conversations and generates shared task lists for patients and families. The company will begin a pilot with Mayo Clinic next month.
- 101MarketSource · Medical Device Network
Bridge to Life raises $110m to advance liver perfusion system’s rollout
Bridge to Life secured $110 million in funding to support US commercialization of its VitaSmart liver perfusion system, expand its product portfolio, and scale global operations. The capital will accelerate market entry and broader international deployment of the organ perfusion technology.
- 102RegulationSource · Medical Device Network
Zepto Life Technology wins $8.9m NIH contract for fungal infection panel
Zepto Life Technology secured an $8.9 million contract from the National Institute of Allergy and Infectious Diseases (NIAID) to advance its fungal infection diagnostic panel. The award follows the panel's FDA breakthrough device designation in June 2026, recognizing potential clinical advantages in rapid fungal pathogen identification.
- 103MarketSource · Medical Device Network
Abbott and Google Health partner for glucose monitoring solutions
Abbott and Google Health announced a partnership to integrate continuous glucose monitoring with AI-driven health guidance within Google Health's platform. The collaboration combines Abbott's monitoring hardware with Google's software and AI capabilities to deliver glucose data and personalized insights to users.
- 104RegulationSource · Medical Device Network
Bracco’s VueJect contrast system secures FDA and Health Canada approvals
Bracco Imaging received FDA 510(k) clearance and Health Canada authorization for its VueJect contrast delivery system. The device enables automated injection of contrast media during medical imaging procedures. The approvals expand Bracco's contrast-delivery portfolio in North American markets.
- 105RegulationSource · Medical Device Network
Elevation Spine lands FDA clearance for expandable interbody fusion system
Elevation Spine received FDA clearance for Saber-XA, an expandable interbody fusion system for spinal surgery. The clearance follows the company's July approval of the Saber-C AVIA cervical fixation device, expanding its portfolio of spinal fusion solutions.
- 106MarketSource · Medical Device Network
Alcon raises 2026 earnings growth outlook on positive Q2 results
Alcon reported strong Q2 results and raised its 2026 earnings growth outlook. The surgical segment generated approximately $1.6 billion in revenue, representing 8% year-over-year growth and accounting for the largest share of company profits.
- 107MarketSource · Medical Device Network
Teledyne agrees to acquire Varex Imaging for $1.1bn
Teledyne Technologies agreed to acquire Varex Imaging for approximately $1.1 billion in an all-cash transaction. Varex, a supplier of X-ray imaging components and subsystems used in medical, industrial, and security applications, becomes part of Teledyne's portfolio. The deal expands Teledyne's presence in medical imaging technology and component supply.
- 108RegulationSource · Medical Device Network
Acarix secures approval in UAE for CADScor system
Acarix has obtained regulatory approval for its CADScor system in the United Arab Emirates, enabling commercial distribution of the device in the region. CADScor is a non-invasive diagnostic system for coronary artery disease assessment.
- 109RegulationSource · MedCity News
How CMS Is Tackling ‘Coverage Purgatory’ for Medical Devices
CMS announced details of its new RAPID pathway, designed to accelerate Medicare coverage decisions for breakthrough medical devices following FDA approval. The initiative addresses a longstanding industry challenge where devices can languish in coverage limbo for years after regulatory clearance, with generally positive industry reception.
- 110RegulationSource · Medical Device Network
Labcorp’s advanced melanoma CDx secures FDA approval
Labcorp received FDA approval for a companion diagnostic (CDx) test that detects BRAF V600E and V600K mutations in melanoma patients to identify candidates for BRAF inhibitor therapy. The test enables treatment selection for eligible patients.
- 111TechnologySource · Medical Device Network
The biggest opportunity to improve lung cancer survival isn’t a new drug
Chris Wood, CEO of RevealDx, discusses the role of AI-based characterization of lung nodules (CADx) in improving lung cancer survival outcomes. The commentary positions software-based diagnostic tools as a key opportunity in the clinical workflow rather than pharmaceutical innovation alone.
- 112MarketSource · Medical Device Network
Resmed’s stock falls by 7% on soft FY27 outlook
ResMed's stock declined 7% following the company's cautious FY27 guidance. The manufacturer cited suspended ventilator sales and macroeconomic uncertainty as headwinds affecting its outlook. The ventilator suspension signals potential supply-chain or regulatory constraints impacting a key product line.
- 113New productsSource · Medical Device Network
RenovoRx reports RenovoCath’s first clinical use in sarcoma
RenovoRx announced the first commercial clinical use of its RenovoCath device in treating a sarcoma patient. RenovoCath is a catheter-based delivery system designed for localized cancer therapy. The milestone marks initial market adoption of the device following prior regulatory or clinical milestones.
- 114MarketSource · MedCity News
Two Differing POVs Emerge About the Hinge-Cylinder Deal
Hinge Health acquired Cylinder to expand into gastrointestinal care offerings. The deal represents a strategic move into a new clinical domain, though industry observers are divided on whether employers will prioritize the convenience of an integrated platform over specialized standalone solutions for GI diagnostics and treatment.
- 115MarketSource · Medical Device Network
iRhythm advances cardiac monitoring provision with $287.5m VitalConnect acquisition
iRhythm Technologies acquired VitalConnect for $287.5 million, expanding its cardiac monitoring portfolio. The deal was announced alongside iRhythm's Q2 results, which showed revenue growth of 20.1% year-over-year. VitalConnect's wearable monitoring technology complements iRhythm's existing cardiac diagnostic capabilities.
- 116MarketSource · Medical Device Network
Philips broadens patient monitoring capabilities with six new partnerships
Philips announced six new partnerships aimed at expanding its patient monitoring ecosystem, particularly for out-of-hospital monitoring capabilities. The partnerships are designed to broaden Philips' reach and integration options in remote patient monitoring and connected care delivery.
- 117RegulationSource · Medical Device Network
Co-Diagnostics files FDA 510(k) for flu and RSV PCR test
Co-Diagnostics filed a Dual 510(k) premarket notification with the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test. The filing seeks clearance for a molecular diagnostic assay capable of detecting influenza A, influenza B, and respiratory syncytial virus from upper respiratory specimens in a single test.
- 118RegulationSource · Medical Device Network
Health Canada approves Kardium’s Globe pulsed field system
Health Canada has approved Kardium's Globe pulsed field system, an integrated cardiac mapping and ablation platform. The clearance marks regulatory authorization for the device in the Canadian market.
- 119RegulationSource · Medical Device Network
Medtronic’s ablation system lands ventricular arrhythmia indication expansion in Europe
Medtronic's ablation system has received a regulatory indication expansion in Europe for ventricular arrhythmia treatment. The company is also generating clinical data to support a similar FDA clearance in the US for the same indication.
- 120RegulationSource · Medical Device Network
BlueWind Medical lands FDA clearance for UUI implant with 15-year lifespan
BlueWind Medical received FDA clearance for Revi Extend, an implantable neuromodulation device for urgency urinary incontinence (UUI) with a 15-year battery lifespan. The company plans to begin limited U.S. market launch in Q4 2026.