Regulatory Approval Archives | Page 18 of 54 | Medical Device News by Guided Solutions

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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

BiVacor wins FDA breakthrough nod for Total Artificial Heart

CoreMap wins FDA IDE for ablation mapping tech

Distalmotion wins FDA nod for gallbladder removal with surgical robot

AnX Robotica wins FDA nod for next-gen gastrointestinal motility capsule

Route 92 Medical wins FDA nod for reperfusion system, reports positive...

Atia Vision received FDA investigational device exemption to study OmniVu lens...

Gradient Denervation Technologies wins FDA Breakthrough Device Designation

Intalight gains CE mark approval for DREAM OCT platform

FDA clears Trax Surgical Linkt nitinol compression staple system

Elucent Medical wins FDA Breakthrough Device Designation for EnVisio X1 In-Body...

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