Regulatory Approvals

Pulsenmore’s at-home ultrasound platform, Pulsenmore ES, has received de novo authorisation from the US Food and Drug Administration (FDA). Pulsenmore ES enables pregnant women to...

InterVene announced it received FDA 510(k) clearance for its Recana thrombectomy catheter system. FDA clearance covers the treatment of venous in-stent restenosis (ISR) and native...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Sirona Medical’s Advanced Imaging Suite. This move marks the company’s inaugural receipt of...

Avvio Medical, Inc., a clinical-stage medical device company developing next-generation kidney stone treatment technologies, announced that the U.S. Food and Drug Administration (FDA) has...

The US Food and Drug Administration (FDA) has cleared the YorLabs Intracardiac Imaging System, an intracardiac echocardiography (ICE) platform designed to meet the rising...

Alife Health’s AI-powered selection tool, Embryo Predict, has received the CE Mark certification in compliance with the European Medical Device Regulation (MDR). The tool is...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Terumo Interventional Systems’ (TIS) OPUSWAVE dual sensor imaging system, marking the company’s...

The US Food and Drug Administration (FDA) has cleared NeurAxis’ percutaneous electrical nerve field stimulation (PENFS) system for treating pain linked with a chronic...

Glaukos announced that the FDA approved its Epoxia incision-free alternative to traditional corneal cross-linking procedures. Epoxia offers an advancement in corneal cross-linking for the treatment...