Regulatory Approvals

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

March 19, 2025

Nexalin wins US patent for Alzheimer’s deep-brain stimulation device

June 25, 2024

Nexalin Technology has secured a US patent for its non-invasive, frequency-based, deep-brain stimulation device aimed at treating Alzheimer’s and dementia. The US Patent and Trademark...

Elixir Medical wins FDA breakthrough nod for sirolimus-eluting bioadaptor system

June 20, 2024

Elixir Medical received FDA breakthrough device designation for its DynamX bioadaptive implant. The breakthrough nod covers the improvement of coronary luminal diameter, restoration of...

AtHeart Medical reports positive data for ASD occluder with bioresorbable frame

June 19, 2024

AtHeart Medical today announced positive long- and short-term clinical outcomes for its reSept atrial septal defect (ASD) occluder.Data from three patient cohorts showed positive...

CardioFlow wins CE mark for VitaFlow Liberty TAVI system

June 19, 2024

MicroPort CardioFlow Medtech Corp. today announced that it received CE mark for its second-generation aortic valve implant.The VitaFlow Liberty transcatheter aortic valve implant (TAVI)...

Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial

June 17, 2024

Xeltis announced it received FDA investigational device exemption (IDE) to begin a pivotal study of its restorative vascular access conduit. aXess enables the creation...

Aktiia wins CE mark for calibration-free optical blood pressure measuring tech

June 14, 2024

Aktiia has won CE marking for its optical blood pressure measuring technology that does not require calibration from a traditional cuff, opening integration into...

BD receives clearance for new blood collection device

June 12, 2024

Becton, Dickinson and Company (BD) has obtained 510(k) clearances from the US Food and Drug Administration (FDA) for its new fingertip blood collection device,...

Evolution Optiks secures 510(k) clearance for new eye examination device

June 10, 2024

Light field technology company Evolution Optiks has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its LFR-260, which is claimed...

Intuitive earns updated FDA labeling on da Vinci X, Xi for radical prostatectomy

June 6, 2024

Intuitive announced the FDA cleared a labelling revision for its da Vinci X and Xi surgical robotic platforms. It is based on real-world evidence...

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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