Features
Calcivis eyes US growth after securing PMA from FDA
Dental imaging technology company Calcivis is setting its sights on US growth having secured pre-market approval (PMA) from the US Food and Drug Administration (FDA). Read more
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ONWARD Medical's ARC-EX granted FDA Breakthrough Device Designation
ONWARD Medical, a medical technology company focused on spinal cord injury (SCI), has been granted Breakthrough Device Designation status from the FDA for the use of its ARC-EX platform for bladder control, alleviation of spasticity and BP regulation Read more
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Medtronic relaunches Harmony TPV System
Medtronic has relaunched its Harmony Transcatheter Pulmonary Valve (TPV) System, a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT). Read more
Medovate and Qualitech strike deal to support SAFIRA roll out
Medovate, a Cambridge based manufacturer of medical technologies created from within the NHS, has concluded an agreement with Qualitech Healthcare to support the roll out of the innovative SAFIRA system to hospitals in the UK. Read more
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Zephyrus receives first FDA clearance for safety syringe
Zephyrus Innovations, a privately owned medical device company designing and manufacturing safety syringes and Closed System Transfer Devices (CSTDs), has received its first product 510(k) approval from the FDA for its Aeroject 3ml safety syringe. Read more
