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.
Teleflex received FDA breakthrough device designation for its Freesolve RMS coronary scaffold, intended for percutaneous coronary intervention (PCI). Breakthrough status expedites FDA review and signals potential clinical significance for the device.
The UK government has confirmed indefinite recognition of EU CE marks for medical devices, reversing earlier post-Brexit plans that would have required separate UK certification by 2030. The decision allows CE-marked medical technology to circulate in the UK market without additional regulatory approval, simplifying compliance for suppliers operating across both markets.
Edwards Lifesciences has secured FDA approval for PASCAL Precision, a tricuspid valve repair system. The approval marks clearance of the minimally invasive device for treatment of tricuspid regurgitation in eligible patients.
The American Medical Association submitted comments on the FDA's proposed regulatory framework for generative AI-based medical devices, urging the agency to prioritize safety over speed in approval processes and calling for physician input on clinical performance standards and evaluation criteria for AI-driven medtech.
Abbott obtained CE Mark approval under the EU's In Vitro Diagnostic Regulation (IVDR) for Cologuard Plus, a colorectal cancer screening test. The regulatory clearance permits the company to market the diagnostic across European Union member states.
Rick Abramson, director of the FDA's Digital Health Center of Excellence and a radiologist, stated that generative AI-enabled medical tools may require regulatory assessment frameworks distinct from traditional devices. Abramson suggested these tools behave more like physician decision-support systems than conventional hardware, implying the FDA may need to adapt its approval and oversight approach for AI-driven diagnostics and clinical software.
Medtronic's Vitalis pacemaker portfolio has secured CE mark approval in Europe. The five-device portfolio uses conduction system pacing technology to stimulate the heart's native electrical pathways, enabling physicians to deliver therapy closer to the heart's natural conduction system.
The WHO granted an emergency use listing (EUL) to bioMérieux's BioFire Ebola panel for detection of Bundibugyo virus, making it the fifth diagnostic to receive such authorization since the outbreak was declared a public health emergency in May 2026. The listing enables rapid deployment of the multiplexed PCR assay in affected Central African regions.
Masimo received FDA clearance for atrial fibrillation detection via its Radius VSM vital signs monitor using photoplethysmography (PPG) technology. The clearance expands the platform's capabilities following a June 2026 clearance for opioid-induced respiratory depression detection on the same device.
The FDA has cleared Sequel Med Tech's twiist AID system for adults aged 18 and older with insulin-treated type 2 diabetes. The clearance expands the automated insulin delivery platform's authorized use from type 1 diabetes, marking a significant regulatory milestone for the vendor's diabetes management portfolio.
Edwards Lifesciences' SAPIEN M3 transcatheter mitral valve replacement system delivery component has been linked to one patient death and one serious injury, according to an FDA alert issued as of October 5. The specific failure mode and scope of affected devices were not detailed in the available information.
GE HealthCare obtained CE Mark certification for its MINItrace Magni cyclotron and expanded its PETtrace Solid Target Platform to support Copper-64 production. The cyclotron is used in radiopharmaceutical manufacturing for positron emission tomography imaging.
The FDA issued a warning letter to Olympus following inspections at six of the company's international manufacturing sites completed in late 2025, citing manufacturing failures. The warning triggered a sharp decline in Olympus' share price, signaling regulatory enforcement action against a major medical device supplier.
Centinel Spine received FDA approval to expand ProDisc C Nova, its cervical total disc replacement system, for two-level use. The expansion permits the device to treat degenerative disc disease across two adjacent vertebral levels in the cervical spine, broadening its clinical application from prior single-level clearance.
Stryker received FDA 510(k) clearance for Sonopet 3, an ultrasonic surgical platform designed for bone and soft tissue removal. The device represents an update to the company's existing Sonopet line of ultrasonic instruments used in orthopedic and general surgical procedures.
The FDA granted 510(k) clearance to Providence Medical Technology for the CORUS Posterior Cervical Stabilization System 3D-T, a spinal fixation device designed for posterior cervical spine surgery. The clearance permits market distribution of the system for stabilization of the cervical spine in indicated patient populations.
Butterfly Medical obtained EU MDR (Medical Device Regulation) certification for its Butterfly Prostatic Retraction Device, a benign prostatic hyperplasia implant. The certification clears the device for commercial distribution across European Union member states.
Happy Health received FDA clearance for a wearable ring that continuously measures blood pressure without a cuff or external calibration. The device represents a new form factor for non-invasive blood pressure monitoring, eliminating the need for traditional cuff-based measurement.
A Morgan Lewis partner discusses the FDA's recently released discussion paper on regulating generative AI in medical technology. The conversation covers the agency's proposed framework for oversight of GenAI-based devices, including potential pathways for clearance and post-market monitoring, as the FDA shapes regulatory strategy around AI-driven medical tools.
The FDA has issued a discussion paper proposing a regulatory framework for generative AI in medical devices, with stakeholder feedback open until October 19, 2026. The proposal addresses oversight of GenAI-based medtech products, including questions around pre-market review, post-market monitoring, and software change management. Suppliers and device makers are invited to submit comments on the agency's evolving approach to AI regulation.
E2 received FDA clearances for its integrated Hēlo thrombectomy platform, which includes the Hēlo Return system that aspirates blood during thrombectomy procedures and returns it to patients. The clearances enable broader clinical deployment of the VTE treatment workflow.
The FDA released draft guidance on pre-market testing requirements for robotic surgical devices, prompting discussion about whether hospital operating room infrastructure can support the growing complexity of these systems. The guidance addresses clinical validation and technical standards for robotically-assisted surgery platforms.
The FDA has granted 510(k) clearance to Urolution Medical for its OpenFlo urinary catheter. The clearance permits market distribution of the device in the United States. Details on specific clinical claims or differentiation versus predicate devices were not provided in the announcement.
Boston Scientific has filed a lawsuit against J&J subsidiary Atraverse alleging patent infringement related to the Hotwire cardiology device system. Boston is seeking an injunction and damages. The case concerns intellectual property rights over the contested device technology.
Argus Cognitive received FDA clearance for Neurora, a diagnostic tool designed to support clinical assessment of autism in pediatric patients. The device is intended to complement rather than replace clinician judgment in diagnosis.
Sonorous Medical received FDA Investigational Device Exemption (IDE) approval to initiate a pivotal trial for BosSTENT, a stent designed to treat pulsatile tinnitus. The device previously earned FDA breakthrough device designation in February 2026, expediting its development pathway toward potential market clearance.
Science Corporation's PRIMA retinal implant demonstrated sustained sight improvements in geographic atrophy patients at 36 months in its pivotal trial, according to newly published results. The findings arrive as the FDA reviews the device for US market approval. The implant addresses a key indication in age-related macular degeneration with no current treatment options.
Happy Health's wearable ring device has received FDA clearance for blood pressure measurement, expanding its approved indications beyond its prior clearance for sleep apnoea diagnosis and monitoring. The clearance adds a new clinical function to the existing homecare monitoring platform.
The UK government has endorsed a healthcare commission blueprint for regulating AI-enabled medical devices, aiming to balance innovation encouragement with safety guardrails. The policy shift signals a regulatory framework change for AI-integrated devices in the British market, affecting how vendors develop and bring such products to market.
Abbott received FDA clearance for software updates to its CardioMEMS HF System, a remote monitoring platform for heart failure patients. The updates introduce new digital features enabling patients to track cardiac data on mobile devices, expanding the system's remote monitoring and data management capabilities.
Autonomix Medical obtained a Canadian patent for its catheter-based tissue monitoring and therapy delivery technology from the Canadian Intellectual Property Office. The patent protection expands the company's IP portfolio for its minimally invasive catheter platform across North America.
Boston Scientific expanded a recall of Infinion CX leads used in its spinal cord stimulator system after over 1,000 injuries were reported. The recall affects a key component of the company's neuromodulation product line.
The FDA has approved Edwards Lifesciences' Autus expandable pulmonary valve for paediatric patients, marking the first FDA-cleared heart valve designed to expand post-implantation to accommodate a child's growth. The device addresses a clinical need in paediatric cardiology where traditional fixed valves require multiple replacement surgeries as children grow.
The FDA has granted clearance to Cepheid for its Xpert Respiratory Panel, a multiplex PCR diagnostic test designed to detect multiple respiratory pathogens. The clearance enables market distribution of the assay, which runs on Cepheid's GeneXpert platform.
DreaMed Diabetes obtained FDA 510(k) clearance for MODI, a mobile application that integrates continuous glucose monitoring data to generate insulin dosing recommendations for Type 2 diabetes patients on basal and fast-acting injection regimens. The clearance expands the tool's indication from prior single-injection use cases.
Intuitive Surgical has obtained CE mark approval for its da Vinci 5 robotic surgical system for cardiac procedures in Europe, enabling the company to re-enter the European cardiac surgery market. The clearance represents a significant regulatory milestone and positions Intuitive to expand its robotic surgery footprint in the region.
The FDA cleared Marani Health's M•wrap, a remote maternal monitoring system designed to enable at-home monitoring of fetal and maternal heart signals. The device allows patients to avoid clinic visits for routine monitoring.
The FDA granted breakthrough device designation to Glytec's Glucommander Pediatrics, an insulin dosing recommendation algorithm intended for hospitalized newborns and infants under two years old. Breakthrough designation accelerates review pathways for devices addressing unmet clinical needs.
An FDA advisory panel voted 7-2 to endorse GRAIL's Galleri multi-cancer early detection test, finding that its clinical benefits outweigh risks. The panel's recommendation supports the company's pathway toward potential regulatory clearance for this blood-based screening assay designed to detect multiple cancer types in asymptomatic individuals.
NET Recovery received FDA Breakthrough Device designation for a neurostimulation device designed to treat psychostimulant addiction by reducing cravings in patients with stimulant use disorder. The designation expedites the device's regulatory pathway.
188 older regulation stories available.