Regulatory Approval Archives

Sibel Health raises $30 million, adds seventh FDA clearance

March 21, 2025

Cardiac Dimensions snags $53m for mitral valve device

March 21, 2025

Brainomix concludes $18m fund raise to strengthen US presence

March 21, 2025

Synchron unveils cognitive AI foundational model for BCI developed with Nvidia

March 20, 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

[hubspot type=form portal=25601863 id=e07d0241-001f-4840-8c08-6e5a4f7af710]

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

Eventum Orthopaedics secures £3.8m following knee op device roll-out

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

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

FDA approves early feasibility study of Valcare’s transcatheter device

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

Q’Apel Medical wins CE mark for Armadillo neurovascular access system

Biobot Surgical wins CE mark for Mona Lisa surgical robot

FDA grants IDE approval for the pivotal trial of Roivios’ JuxtaFlow®...

Axial3D secures $18m in equity funding

Onward wins FDA De Novo classification for non-invasive spinal cord stimulation...

Cercare Medical secures FDA clearance for CT Perfusion Imaging software

FemPulse wins FDA IDE for for overactive bladder neuromod

SyntheticMR wins FDA nod for SyMRI 15 imaging solution

Vision RT wins CE Mark certifications for DoseRT, MapRT and Respiratory...

Lungpacer Medical wins FDA premarket approval for AeroPace neurostim system

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

Synchron unveils cognitive AI foundational model for BCI developed with Nvidia

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