Regulatory Approval Archives | Page 34 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

THINK Surgical’s TMINI Miniature Robotic System developed with Sagentia Innovation gains...

Artiria Medical announces that its real-time deflectable guidewire has been granted...

iHealthScreen receives FDA 510(k) for AI-enabled eye screening system

Meet the tiny, wireless sleep apnea diagnostic wearable headed for the...

Beta Bionics Announces FDA Clearance and Commercialization of the iLet Bionic...

Abbott Receives FDA Clearance for Assert-IQ™ Insertable Cardiac Monitor to Help...

inHEART has received CE certification under the new MDR for its...

Omeq Medical Receives FDA Regulatory Clearance for its Smart Device for...

bioMérieux receives US FDA CLIA-waiver for the BIOFIRE® SPOTFIRE® Respiratory (R)...

Terumo Aortic announces FDA approval of dissection and transection indication expansion...

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