Regulatory Approvals

FDA approves BioIntelliSense’s BioButton wearable for patient monitoring

BioIntelliSense has received approval from the US Food and Drug Administration (FDA) for its BioButton Multi-Patient wearable and BioDashboard system for continuous patient monitoring. The...

US FDA clears Elucid’s PlaqueIQ imaging analysis software

PlaqueIQ is a non-invasive software that can objectively quantify and classify plaque morphology based on ground-truth histology, and is designed to give physicians new,...

FDA clears Surmodics’ Pounce XL thrombectomy system

Surmodics received FDA 510(k) clearance for its Pounce XL thrombectomy system. The FDA indicated Pounce XL for the non-surgical removal of thrombi and emboli...

Pi-Cardia wins FDA nod for leaflet modification device that enables TAVR

Pi-Cardia announced the FDA granted clearance for its ShortCut leaflet modification device for TAVR procedures. Rehovot, Israel-based Pi-Cardia designed ShortCut to split the leaflets...

Human in Motion Robotics secures Canadian approval for XoMotion exoskeleton

Robotic mobility and humanoid technology company Human in Motion Robotics has received regulatory approval to market and sell the XoMotion exoskeleton in Canada. It is...

Nevro wins FDA nod for AI-driven spinal cord stimulation tech

Nevro received FDA approval for an AI-powered, personalised pain management platform for spinal cord stimulation. HFX AdaptivAI, a responsive, personalised pain management platform, powers...

FDA approves study of Alpha Tau’s Alpha DaRT for recurrent cSCC treatment

The US Food and Drug Administration (FDA) has granted approval for Alpha Tau Medical’s investigational device exemption (IDE) application to initiate a study of...

Avicenna.AI receives 510(k) clearance for CINA-CSpine tool

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Avicenna.AI’s CINA-CSpine tool. This AI solution is developed to automatically detect and prioritise...

Alesi Surgical wins new funding and FDA clearance for smoke management device

Alesi Surgical has received FDA 510(k) clearance of its Ultravision2 IonPencil for cutting and coagulating soft tissue in open surgery while managing surgical smoke....
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