Regulatory Approvals

Spirair receives FDA clearance for SeptAlign system in NSD correction

Spirair has secured 510(k) clearance for its SeptAlign system from the US Food and Drug Administration (FDA) for its use in the mechanical correction...

FDA approves Symani surgical robot platform from Medical Microinstruments

Medical Microinstruments announced today that the FDA granted de novo clearance for its Symani surgical robot platform.Clearance covers soft tissue manipulation to perform microsurgery....

Neurovalens wins FDA nod for anxiety-treating neuromod device, raises $2.65M

Neurovalens announced today that it received FDA clearance for its Modius Stress device for treating anxiety and raised $2.65 million.Belfast, Northern Ireland-based Neurovalens designed...

Kelyniam and Finceramica announce FDA clearance for NEOS system

Kelyniam Global and Finceramica Faenza have announced the Food and Drug Administration (FDA) 510(k) clearance for the NEOS Surgery Cranial LOOP fixation system to...

FDA authorises Prenosis’ AI-based tool for sepsis diagnosis

The US Food and Drug Administration (FDA) has granted marketing authorisation for Prenosis’ AI tool Sepsis ImmunoScore, to diagnose sepsis. This authorisation, achieved through the...

FDA clears Affinity Biosensors’s LifeScale AST diagnostic platform

The US Food and Drug Administration (FDA) has granted clearance for Affinity Biosensors’s LifeScale AST system, a diagnostic tool for rapid antibiotic susceptibility testing...

WAT Medical wins FDA nod for OTC migraine preventative device

WAT Medical this week won FDA clearance for over-the-counter use of its HeadaTerm 2 wearable anti-migraine device. HeadaTerm 2 uses neuromodulation technology. It releases targeted...

Coreline Soft win FDA 510(k) clearance for AI-powered coronary artery calcification analysis solution

Coreline Soft said its artificial intelligence (AI)-powered coronary artery calcification automatic diagnostic solution, AVIEW CAC, has received 510(k) clearance from the U.S. FDA. A 510(k)...

Tandem Mobi automated insulin pump wins FDA nod for expanded pediatric use

Tandem Diabetes Care (Nasdaq:TNDM) announced that the FDA cleared its Mobi insulin pump for an expanded pediatric indication.The FDA approved Tandem’s 510(k) application for...
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