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…
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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…
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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…
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…
Distalmotion receives FDA 510(k) clearance for Dexter robotic system
The clearance authorises the use of Dexter in ventral hernia repairs, a common US outpatient procedure.
Optellum and Coreline Soft plan AI integration for lung nodule care
The proposal seeks to combine Coreline Soft's image-based CADe with Optellum's CADx, risk assessment, and management.
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.
Freenome’s lung cancer test receives FDA breakthrough status
The SimpleScreen test is designed to detect early lung cancer signals from a standard blood sample.
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…
Enrolment concludes in BD’s PREVENT trial of Phasix Mesh
The trial has enrolled 477 patients at 32 investigational sites located in the US and Europe.
Bridge to Life raises $110m to advance liver perfusion system’s rollout
Beyond supporting its VitaSmart system's US rollout, Bridge to Life also intends to use the funds to expand its portfolio…
Why your manufacturing floor is your greatest compliance risk – and opportunity
The manufacturing floor represents the primary source of life sciences compliance risks and data integrity failures. Transitioning from paper-based processes…