Regulatory Approval Archives | Page 17 of 54 | Medical Device News by Guided Solutions

GS MedTech Funding Tracker – Tissium, CroíValve, and more

June 26, 2026

Coherence Neuro begins first clinical study for BCI

June 26, 2026

Pulsenmore announces pricing of $7.5M Private Placement

June 26, 2026

Carvolix secures new €10M tranche, bringing total financing to €20M

June 25, 2026

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

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

Valgen earns CE mark for mitral valve repair system

AorticLab earns expanded CE mark for embolic protection device

LEM Surgical wins new FDA clearance for humanoid surgical robot

Masimo gets FDA nod for AI-enabled opioid-induced respiratory depression detection tech

Coherence Neuro begins first clinical study for BCI

Imperative Care reports SYMPHONY-PE trial data for pulmonary embolism

VahatiCor enrolls first U.S. patient in SERRA-I clinical study of A-FLUX Reducer System

Raydiant Oximetry completes enrollment of First 15 Patients in IDE Pilot Study

Cardiawave reports first Valvosoft treatments in Europe

Xtant Medical launches Trivium Shaped allograft for surgeries

Neuvotion to launch neurostim for post-stroke recovery

Reflow Medical launches next-gen microcatheters

Spectrum Vascular acquires catheter guidance tech developer Piccolo Medical

Novanta outlays $1.45B for Riverpoint Medical buyout

Olympus agrees $270M BioProtect buyout to expand prostate cancer offerings

Endologix acquires Pounce thrombectomy system from Surmodics

Pulsenmore announces pricing of $7.5M Private Placement

Carvolix secures new €10M tranche, bringing total financing to €20M

Tissium closes $68M financing for tissue reconstruction polymers

CroíValve closes expanded Series B at $36M

Tag: Regulatory Approval

FDA grants 510(k) clearance to Viz.ai’s Viz Subdural Plus module

GI Windows Surgical wins FDA nod for Flexagon self-forming magnet tech

InspireMD’s embolic prevention system gains CE Mark approval

Creo Medical secures FDA clearance for SpyderBlade Flex device

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

Foldax gets India approval for polymer mitral heart valve

Avicenna.ai secures CE marks for two AI fracture detection tools

AIATELLA raises €2m for AI-powered cardiovascular imaging tools

GS MedTech Funding Tracker – Tissium, CroíValve, and more

Coherence Neuro begins first clinical study for BCI

Pulsenmore announces pricing of $7.5M Private Placement

Carvolix secures new €10M tranche, bringing total financing to €20M

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