Regulatory Approvals

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

March 19, 2025

Tandem Mobi automated insulin pump wins FDA nod for expanded pediatric use

April 4, 2024

Tandem Diabetes Care (Nasdaq:TNDM) announced that the FDA cleared its Mobi insulin pump for an expanded pediatric indication.The FDA approved Tandem’s 510(k) application for...

Fractyl Health receives IDE approval for Revita trial

April 3, 2024

US-based biotech Fractyl Health has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct a clinical trial...

FDA clears Eko Health’s AI for heart failure detection

April 3, 2024

Eko Health announced today that the FDA cleared its Low EF (ejection fraction) detection AI platform for its digital stethoscope.Using an Eko stethoscope, providers...

Baird receives Class III certificate for thyroid treatment needle

April 2, 2024

Baird Medical has received new Class III certificate for its ceramic thyroid ablation needle from China’s National Medical Products Administration (NMPA). The certificate recognises the...

Synaptive Medical wins FDA nod for near-infrared fluorescence in robotic exoscope

March 29, 2024

Synaptive Medical announced today that it received FDA 510(k) clearance for its near-infrared fluoresence visualization module on its robotic exoscope. The Toronto-based company can...

Implantica prepares for FDA approval of acid reflux device

March 29, 2024

Implantica has started the premarket approval process with the US Food and Drug Administration (FDA) for its gastroesophageal reflux disease (GERD) treatment, RefluxStop. The Liechtenstein-based...

FDA clears sleep monitoring software from Beacon Biosignals

March 29, 2024

Beacon Biosignals announced that it received FDA 510(k) clearance for its SleepStageML machine-learning software for sleep monitoring.SleepStageML automatically stages sleep from electroencephalogram (EEG) signals...

SyntheticMR wins FDA 510(k) clearance for 3D brain scanner

March 28, 2024

SyntheticMR announced today that its next-generation 3D imaging solution with isotropic resolution received FDA 510(k) clearance.Linköping, Sweden-based SyntheticMR said in a news release that...

Endostart bags FDA 510(k) clearance for its magnetic colonoscopy device

March 28, 2024

Italian medical device company Endostart has secured US Food and Drug Administration (FDA) 510(k) clearance for its colonoscopy device, which is designed to optimise...

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

Laplace Interventional raises $22m for tricuspid valve tech

MicroTransponder receives $65m to advance stroke care with Vivistim

Vantis Health completes €10m funding round to advance primary care

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

Regulatory Approvals

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

Synchron unveils cognitive AI foundational model for BCI developed with Nvidia

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

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

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

Synchron unveils cognitive AI foundational model for BCI developed with Nvidia

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

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

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

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