Regulatory Approvals

Bone Solutions gets expanded FDA nod for Mg OSTEOCRETE in intervertebral procedures

Orthobiologics technology company Bone Solutions has received the US Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of Mg OSTEOCRETE in...

Zynex Receives FDA Clearance for its Next Generation NMES Device

Zynex, an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today...

FDA clears Tyber Medical’s Tibia Plating System

Tyber Medical, a provider of private-label orthopaedic implants, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Proximal Tibia...

Mainstay secures FDA approval for MRI labelling on ReActiv8 System

Mainstay Medical has received the US Food and Drug Administration (FDA) approval for full-body MRI conditional labelling for its ReActiv8 Restorative Neurostimulation system. ReActiv8 is...

ProCell secures CE-marked approval for blood recovery unit

ProCell Surgical has received CE-marked approval for its Sponge Blood Recovery Unit, allowing it to enter the European Union market. The certification indicates that ProCell’s...

FDA green lights StimLabs umbilical cord-derived wound graft

The US Food and Drug Administration (FDA) has granted 510(k) clearance to US-based StimLabs wound care device Corplex P.  The device claims to be the...

New UK NICE guidance endorses AI-derived software in stroke assessments

A new guidance document from the UK National Institute of Health and Care Excellence (NICE) has endorsed National Health Service (NHS) deployment of two...

Qure.ai adds new FDA breakthrough device status to growing list of regulatory milestones

Medical imaging AI innovator, Qure.ai, has received breakthrough device designation from the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH)...

Toku secures CE and UKCA mark approvals for CLAiR technology

New Zealand-based medical device company Toku has secured the CE and UKCA marks for its patented CLAiR technology to evaluate cardiovascular disease (CVD) risk. The...
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