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Medical Devices

Sky Labs Secures CE-MDR for 'CART PLATFORM,' Accelerating Its Global Market Entry

Targeting the global healthcare market beyond Europe through CE-MDR certification...

Medtech Incubator Partners with Leap Distributors to Support U.S. Market Expansion Efforts

The new partnership gives Medtech Incubator companies access to a coordinated, nationwide distribution network...

ISC Advances AI in Urology with Singapore Approval for CystoSmart

CystoSmart, an AI software tool for bladder tumour detection in patients undergoing screening and surveillance endoscopic examination of the bladder...

StimLabs Announces FDA Clearance of Theracor

Theracor is a sheet device derived from human umbilical cord extracellular matrix (ECM) intended to cover, protect, and provide a moist wound environment...

Hydreight Technologies Enters At-Home STI Testing Market with Distribution and 50,000 Pre-Orders

Under the agreement, Hydreight will serve as the exclusive distributor of HSC’s at-home STI pre-screen testing kits across its national platform...

Cannabix Secures First Distributor Order for BreathLogix Alcohol Screening Devices in Australia

Cannabix has developed an autonomous alcohol breathalyser screening device for employers and a range of industries and safety settings...

2025 Biological Device Application Approvals. How FDA Clearances Are Reshaping Blood Banking, Diagnostics, and Point of Care Medicine

From blood bank software and immunohematology analysers, to HIV diagnostics and platelet rich plasma systems, the 2025 approval landscape signals a clear shift towards automation, safety, traceability, and point of care innovation across transfusion and laboratory medicine...

Nyxoah’s Stepwise Approach to Expanding OSA Treatment in Europe

Nyxoah is advancing a differentiated approach to sleep apnea treatment through its Genio system, a bilateral, externally powered hypoglossal nerve stimulation therapy designed specifically for patients who are unable to tolerate CPAP...

ALZpath and Siemens Healthineers Sign Licensing Agreement to Advance Global Access to Blood-Based Alzheimer’s Disease Diagnostic Testing

Siemens Healthineers will utilise ALZpath’s high-performing, proprietary pTau217 antibody in its growing test menu for its Atellica analysers to enable IVD testing for Alzheimer’s disease...

How FDA Approval Puts Biomoneta on the Global Map of Infection-Prevention Tech

Ghatak also sheds light on investor support from BNV India and Beyond Next Ventures...