Regulatory Approval Archives | Page 38 of 38 | Medical Device News by Guided Solutions

Somnee raises $10m for AI neurotech sleep wearables

June 12, 2025

Wandercraft raises $75M to support AI-powered robotic exoskeleton

June 12, 2025

Volta Medical wins expanded labelling for AI decision support system

June 12, 2025

Atraverse raises $29.4M for left-heart access device

June 11, 2025

Featured

Guided Solutions Celebrates 25 Years of Transforming Executive Search in MedTech

April 24, 2025

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

Newsletter

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Somnee raises $10m for AI neurotech sleep wearables

Wandercraft raises $75M to support AI-powered robotic exoskeleton

Atraverse raises $29.4M for left-heart access device

Flux Robotics secures pre-seed funding to accelerate safer magnetic surgeries

FineHeart can begin first-in-human LVAD trial of its FlowMaker device

NeuroPace reports one-year data on neuromodulation therapy for epilepsy

Inner Cosmos shares data for psychiatric BCI technology

EnVVeno has first-in-human heart valve data, expects FDA decision this year

FastWave Medical reports first-in-human use of coronary laser IVL system

Paradromics reports first-in-human Connexus BCI procedure

Terumo Neuro launches Sofia Flow 88 catheter for stroke care

Auxilium Biotechnologies launches nerve regeneration device trial

Volta Medical wins expanded labelling for AI decision support system

FDA grants 510(k) clearance for SpineUp’s Frida solution

TYBR Health secures FDA 510(k) Clearance for B3 GEL System

Newel Health obtains EU MDR for blood pressure management platform

RadNet acquires See-Mode to bolster AI ultrasound screening for thyroid cancer

Highridge Medical sells Bone Healing unit to Avista

ElectroCore completes acquisition of NeuroMetrix

Firefly Neuroscience acquires Evoke Neuroscience for $6m

Tag: Regulatory Approval

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

Somnee raises $10m for AI neurotech sleep wearables

Wandercraft raises $75M to support AI-powered robotic exoskeleton

Volta Medical wins expanded labelling for AI decision support system

Atraverse raises $29.4M for left-heart access device

Guided Solutions Celebrates 25 Years of Transforming Executive Search in MedTech

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