Regulatory Approvals

Spectrumedics’ IVL catheter gains EU CE mark

Spectrumedics Medical has obtained a CE mark for its coronary intravascular lithotripsy (IVL) system under the European Union’s Medical Device Regulation (EU MDR). Related: StimLabs...

StimLabs announces FDA clearance of Theracor

StimLabs announces that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for Theracor, the first human umbilical cord-derived medical device to...

SleepRes wins FDA nod for CPAP alternative

SleepRes announced that it received FDA 510(k) clearance for its Kricket PAP device for treating obstructive sleep apnea (OSA). Kricket PAP is powered by the...

FDA clears CMR Surgical’s Versius Plus robot

CMR Surgical has secured US Food and Drug Administration (FDA) clearance for its Versius Plus minimally invasive robotic surgical system, priming the company to...

Medivis wins FDA clearance for AR cranial navigation platform

Medivis announced today that it received FDA 510(k) clearance for its augmented reality (AR)-powered Cranial Navigation platform. The company said clearance makes Cranial Navigation the...

May Health gains CE mark for infertility treatment

France-based May Health has secured a European CE mark for its Anavi system to address infertility in women with polycystic ovary syndrome (PCOS). The system...

Vesalio secures FDA clearance for enVast clot retriever

The Food and Drug Administration (FDA) has granted 510(k) clearance for Vesalio’s enVast clot retriever, paving the way for its commercial launch in the...

Nephrodite’s continuous dialysis implant wins FDA breakthrough device designation

The FDA has granted Breakthrough Device Designation to Nephrodite’s Holly implantable continuous dialysis system. In an exclusive interview ahead of the official announcement, Nephrodite co-founder...

Neurovalens receives FDA approval for weight management device

Neurovalens, the Belfast-based neuro-technology company, has been granted approval by the US Food & Drug Administration (FDA) for Modius Lean, its prescribed treatment for...
1...789...114Page 8 of 114

Latest articles