Regulatory Approval Archives

AtaCor Medical enrolls first patient in ASCEND-EV trial

March 25, 2025

Newronika wins CE mark for adaptive DBS for Parkinson’s

March 25, 2025

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

March 24, 2025

Proscia scoops $50m for AI-driven pathology advancement

March 24, 2025

Featured

FDA clears NeurAxis’ self-inflating balloon device RED

January 30, 2025

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

November 6, 2024

Guided Solutions Appoints Manu Chhokra as Managing Director for Switzerland

October 16, 2024

FDA clears portable blood, IV fluid warmer from Mequ

June 10, 2024

Newsletter

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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

AtaCor Medical enrolls first patient in ASCEND-EV trial

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

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

Newronika wins CE mark for adaptive DBS for Parkinson’s

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

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

Tag: Regulatory Approval

Asensus Surgical scores general surgery clearance for its Senhance robot

Push-button blood collection device receives CE mark

First daytime treatment for obstructive sleep apnea receives De Novo authorization

Aktiia receives CE mark for 24/7 blood pressure monitoring system

Spectrum Solutions obtains CE Mark for saliva collection devices

Armis Biopharma announces FDA 510(k) clearance for VeriFixx small bone implant

AtaCor Medical enrolls first patient in ASCEND-EV trial

Newronika wins CE mark for adaptive DBS for Parkinson’s

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

Proscia scoops $50m for AI-driven pathology advancement

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