Regulatory Approvals

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...

FDA grants clearance for Hologic’s cervical cancer screening system

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 receives FDA approval for ReCET System trial

Endogenex has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to commence a pivotal clinical study of the...

NuvoAir’s Air Next Spirometer is FDA-approved for in-home use

NuvoAir Medical announced its innovative Air Next Spirometer has received formal 510(k) clearance for in-home use as a full spirometer. 510(k) approval empowers NuvoAir...

FDA approves Tyber Medical’s Mini-Frag System extension

Tyber Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for an extension to its Mini-Frag System. The approval introduces additional...
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