Regulatory Approvals

FDA clears Imperative Care’s Symphony 16F 82cm catheter

March 24, 2025

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

October 1, 2024

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

September 26, 2024

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

September 25, 2024

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

September 24, 2024

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

September 20, 2024

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

September 20, 2024

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....

FDA clears EEG for brain analysis from Forest Devices

September 19, 2024

Forest Devices received FDA 510(k) clearance for its SignalNED Model RE system for brain state analysis. This marks the first FDA clearance for the...

Spinal surgery company Neo Medical wins $68m to expand US business

September 18, 2024

Swiss spine technology company Neo Medical has raised $68m in a Series B funding round to expand its portfolio of surgical technologies across the...

Epitomee gets FDA approval for ingestible weight management device

September 18, 2024

Israel-based health solutions provider Epitomee Medical has received the US Food and Drug Administration (FDA) approval for its advanced ingestible medical device, Epitomee Capsule. Encased...

1...101112...88 Page 11 of 88

Proscia scoops $50m for AI-driven pathology advancement

Sibel Health raises $30 million, adds seventh FDA clearance

Cardiac Dimensions snags $53m for mitral valve device

Brainomix concludes $18m fund raise to strengthen US presence

RevBio initiates pivotal Europe trial for its dental implant stabilization product

Cognixion launches trial of BCI device paired with AI application for people with ALS

Second Heart Assist’s Whisper device caused less hemolysis compared to Abiomed Impella CP

Lungpacer wins FDA IDE for AeroNova system

Synchron unveils cognitive AI foundational model for BCI developed with Nvidia

Vave Health launches Universal Wireless Probe for full-body imaging

Vitestro launches Aletta robotic phlebotomy device for blood draws

Shockwave Medical launches new Javelin IVL catheter

FDA clears Imperative Care’s Symphony 16F 82cm catheter

Subtle Medical’s software solution gains CE mark for MRI imaging

Moon Surgical gets FDA nod for AI-enhancement for surgical robot

FDA clears robotic knee surgery system from Monogram Technologies

Labcorp Announces Acquisition of Select Assets of BioReference Health’s Innovative Oncology and Related Clinical Testing Services Businesses

Boston Scientific buys Tivus system developer SoniVie in $540m deal

Teleflex acquires Biotronik’s Vascular Intervention business

Demetra Holding Spa acquires majority stake in GetSet Surgical

Regulatory Approvals

FDA clears Imperative Care’s Symphony 16F 82cm catheter

FDA clears Imperative Care’s Symphony 16F 82cm catheter

Proscia scoops $50m for AI-driven pathology advancement

Sibel Health raises $30 million, adds seventh FDA clearance

Cardiac Dimensions snags $53m for mitral valve device

FDA clears Imperative Care’s Symphony 16F 82cm catheter

Proscia scoops $50m for AI-driven pathology advancement

Sibel Health raises $30 million, adds seventh FDA clearance

Cardiac Dimensions snags $53m for mitral valve device

FDA clears NeurAxis’ self-inflating balloon device RED

Guided Solutions Appoints Marco Müller as New Managing Director Germany to Drive Strategic Growth

Guided Solutions Appoints Manu Chhokra as Managing Director for Switzerland

FDA clears portable blood, IV fluid warmer from Mequ