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 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 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...
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...
A new guidance document from the UK National Institute of Health and Care Excellence (NICE) has endorsed National Health Service (NHS) deployment of two...
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)...
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...
The US Food and Drug Administration (FDA) has granted clearance for Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm for...
Endogenex has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to commence a pivotal clinical study of the...
