Curated from medtech publications. Product launches, FDA clearances, M&A, technology shifts — rewritten as short briefs, linked back to the source. Filter by theme below.
Powerful Medical received FDA approval for Queen of Hearts, an AI model that analyzes ECG readings to detect STEMI and STEMI-equivalent patterns associated with acute coronary syndrome. The software is designed to aid in rapid identification of heart attack risk.
Boston Scientific faced an FDA alert linking its spinal cord stimulation (SCS) leads to 1,081 serious injuries. The company operates in a market where multiple medtech vendors are defending personal injury lawsuits tied to SCS system malfunctions, signaling broader reliability concerns across the spinal neuromodulation sector.
The WHO has granted approval for Cepheid's Ebola diagnostic test during an ongoing Bundibugyo virus outbreak in Central Africa, declared a public emergency in May 2026. The clearance enables broader deployment of the rapid diagnostic platform to support outbreak response efforts in affected regions.
Globus Medical received CE mark approval for its Excelsius3D imaging system, enabling commercial distribution in the European Union and UK. The clearance expands the platform's market access beyond existing approvals.
The FDA has cleared Heartvue.Proton, a software tool designed to streamline the evaluation of cardiovascular MRI images. The clearance enables the vendor to market the cardiac image analysis platform to healthcare facilities performing cardiac imaging studies.
Hamamatsu Photonics received FDA 510(k) clearance for the NanoZoomer S20MD and S540MD slide scanner systems. These digital pathology platforms enable high-resolution scanning and analysis of microscope slides for laboratory and clinical use.
Vara received CE mark approval for its autonomous AI-powered breast cancer screening triage system. The clearance signals regulatory acceptance of the company's AI-driven approach to cancer screening workflows, as machine learning tools become more integrated into diagnostic imaging pathways.
Fujirebio received Class II Medical Device Licences from Health Canada for its Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays. These blood-based biomarker tests are used in neurodegenerative disease diagnostics. The clearances expand regulatory authorization for the assays beyond prior markets.
Medibyt, an Israeli digital health company, received FDA 510(k) clearance for CPETWise, a software solution designed to assist in the analysis and interpretation of cardiopulmonary exercise testing (CPET). The clearance enables the company to market the tool in the US.
Vitestro received FDA de novo classification in August 2026 for its Aletta robotic phlebotomy system, which autonomously performs blood draws from tourniquet placement through bandaging. The FDA designation recognizes the device as an innovative approach to blood collection addressing a critical public health need.
GE HealthCare has obtained CE mark approval for its Photonova Spectra photon-counting CT system, clearing the device for commercial distribution in European markets. The certification represents regulatory progression for the photon-counting imaging technology platform.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
135 older regulation stories available.