Regulatory Approvals

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...

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...

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

HeartBeam has secured US Food and Drug Administration (FDA) clearance for its 12-lead electrocardiogram (ECG) synthesis software, setting the arrhythmia assessment tool up for...

Resmed announced that it received FDA clearance for its Smart Comfort personalized therapy offering. San Diego–based Resmed calls Smart Comfort (which was submitted to the...

French MedTech Cardiawave has gained an EU CE mark for its non-invasive ultrasound therapy (NIUT) Valvosoft, marking the first device of its kind available...

Atraverse Medical announced that it received FDA clearance for its fully integrated Hotwire transseptal access system. Hotwire is a novel radiofrequency guidewire left-heart access device....

Francis Medical’s Vanquish device for treating intermediate-risk prostate cancer has been cleared by the US Food and Drug Administration (FDA). Vanquish is a transurethral, ultrasound...