Medical Device News
Latest industry news, regulatory updates, and announcements from trusted sources.
Samsung enters OTC hearing aid space with FDA clearance for Galaxy earbud feature
The FDA’s clearance for the hearing aid feature in Samsung’s Galaxy Buds puts the company in competition with Apple’s AirPods in the OTC hearing aid space. The post Samsung enters OTC hearing aid spac…
Read Full Article →Olympus strikes global distribution agreement for Endocision’s cryocatheter
Under the agreement, the commercial launch of Endocision's cryocatheter in the US, Canada and Europe will be initiated in early 2027. The post Olympus strikes global distribution agreement for Endocis…
Read Full Article →Distalmotion receives FDA 510(k) clearance for Dexter robotic system
Distalmotion has received 510(k) clearance from the FDA for ventral hernia repair with its Dexter robotic surgery system. The post Distalmotion receives FDA 510(k) clearance for Dexter robotic system …
Read Full Article →Optellum and Coreline Soft plan AI integration for lung nodule care
Optellum and Coreline Soft have announced plans to integrate AI to support lung nodule detection and management across international markets and multiple disease areas. The post Optellum and Coreline …
Read Full Article →Cook Medical discloses cyber incident stemming from a scam
An outside party gained access to some company systems, but the medical device maker found no evidence that sensitive or protected data was obtained and said its operations are running normally.
Read Full Article →Thermo Fisher closes $1.1B sale of microbiology unit to PE firm
European private equity firm Astorg will run the business as an independent diagnostics company, led by former PerkinElmer CEO Dirk Bontridder.
Read Full Article →Inside Senseonics’ commercial overhaul and what’s next
The diabetes tech firm recently brought its sales and marketing teams in-house after taking over commercialization of its device from Ascensia Diabetes Care.
Read Full Article →FDA clears Vesalio’s latest mechanical thrombectomy device
Vesalio’s pVasc NET mechanical thrombectomy device integrates clot-capture technology to retain clot fragments during retrieval. The post FDA clears Vesalio’s latest mechanical thrombectomy device app…
Read Full Article →Freenome’s lung cancer test receives FDA breakthrough status
Freenome has secured breakthrough device designation from the FDA for its investigational, blood-based SimpleScreen Lung test for adults. The post Freenome’s lung cancer test receives FDA breakthrough…
Read Full Article →Wandercraft’s self-balancing exoskeleton wins FDA clearance
Wandercraft now plans to initiate a US market launch of its exoskeleton for supporting upright movement in paralysed patients in September 2026. The post Wandercraft’s self-balancing exoskeleton wins …
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