Regulatory Approvals

RevealDx won MDR certification for AI-Powered lung nodule decision support

RevealDx, a leader in the characterization of lung nodules, announces MDR Certification of RevealAI-Lung. The RevealDX product, RevealAI-Lung, characterizes nodules by producing a score called...

Aqua Medical wins FDA IDE to launch trial for ablation procedure that treats diabetes

Aqua Medical has received investigational device exemption (IDE) from the FDA for its ablation device aimed at treating diabetes. The IDE gives the device...

Pulsenmore’s at-home ultrasound secures FDA de novo authorisation

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 wins FDA 510(k) for Recana thrombectomy catheter

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...

FDA grants 510(k) clearance to Sirona Medical’s imaging suite

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 receives FDA Breakthrough for Avvio Enhanced Lithotripsy System

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...

FDA clears YorLabs’ intracardiac imaging system

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 embryo selection tool Embryo Predict gains CE mark

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...

FDA grants 510(k) clearance to Terumo’s dual sensor imaging system

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...
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