FDA Archives

Blackversion PRO

Main Website
News Home
Funding
- OrganOx completes $142m equity financing led by HealthQuest Capital
  
  Funding February 25, 2025
  
  Trinity Capital provides $15m in growth capital to Cagent Vascular
  
  Funding February 24, 2025
  
  Valencia Technologies raises $35m for coin-sized neuromod device
  
  Funding February 21, 2025
  
  VitalConnect reels in $100m investment to expand patient monitoring products
  
  Funding February 21, 2025
Clinical Trials
- CereVasc treats first patient with eShunt system in its STRIDE clinical trial
  
  Clinical Trials February 26, 2025
  
  Onward reports positive spinal cord stim results for ARC-EX
  
  Clinical Trials February 26, 2025
  
  WhiteSwell has positive data for its fluid removal system eLym
  
  Clinical Trials February 14, 2025
  
  MicroTransponder Vivistim nerve stim tech delivers positive stroke outcomes
  
  Clinical Trials February 10, 2025
Innovation
- UroMems reports positive outcomes in first-ever female-only study of smart implant for incontinence
  
  Innovation February 25, 2025
  
  BetaGlue enters exclusive global agreement with Artivion for BioGlue
  
  Innovation February 21, 2025
  
  Plexāā secures manufacturing deal for breast cancer surgery prep device
  
  Innovation February 17, 2025
  
  Fractyl Health to focus on Revita and Rejuva Programs
  
  Innovation February 13, 2025
Regulatory Approvals
- Averto Medical won FDA breakthrough device designation for ColoSeal
  
  Regulatory Approvals February 26, 2025
  
  FDA clears Atreon’s bioresorbable synthetic implant for rotator cuff repair
  
  Regulatory Approvals February 24, 2025
  
  CathVision’s ECGenius system gains CE Mark, enabling European distribution
  
  Regulatory Approvals February 24, 2025
  
  QuantalX’s brain health assessment device gains CE MDR approval
  
  Regulatory Approvals February 17, 2025
Mergers & Acquisitions
- Globus Medical to acquire Nevro for $250m to expand treatment options
  
  Mergers & Acquisitions February 7, 2025
  
  Zimmer Biomet announces definitive agreement to acquire Paragon 28
  
  Mergers & Acquisitions January 29, 2025
  
  Kaneka acquires EndoStream Medical
  
  Mergers & Acquisitions January 13, 2025
  
  Boston Scientific to acquire remaining ownership stake in Bolt Medical for $664m
  
  Mergers & Acquisitions January 10, 2025
Featured

Guided Solutions - Connecting Talent With Innovation

/div>

OrganOx completes $142m equity financing led by HealthQuest Capital

Trinity Capital provides $15m in growth capital to Cagent Vascular

Valencia Technologies raises $35m for coin-sized neuromod device

VitalConnect reels in $100m investment to expand patient monitoring products

CereVasc treats first patient with eShunt system in its STRIDE clinical trial

Onward reports positive spinal cord stim results for ARC-EX

WhiteSwell has positive data for its fluid removal system eLym

MicroTransponder Vivistim nerve stim tech delivers positive stroke outcomes

UroMems reports positive outcomes in first-ever female-only study of smart implant for incontinence

BetaGlue enters exclusive global agreement with Artivion for BioGlue

Plexāā secures manufacturing deal for breast cancer surgery prep device

Fractyl Health to focus on Revita and Rejuva Programs

Averto Medical won FDA breakthrough device designation for ColoSeal

FDA clears Atreon’s bioresorbable synthetic implant for rotator cuff repair

CathVision’s ECGenius system gains CE Mark, enabling European distribution

QuantalX’s brain health assessment device gains CE MDR approval

Globus Medical to acquire Nevro for $250m to expand treatment options

Zimmer Biomet announces definitive agreement to acquire Paragon 28

Kaneka acquires EndoStream Medical

Boston Scientific to acquire remaining ownership stake in Bolt Medical for $664m

Tag: FDA

EchoNous scales up portable ultrasound platform with FDA OK for full-body...

Able Medical Announces FDA 510K Clearance for the MACH™ Screw Clip...

3NT Medical Announces FDA Clearance for Single-Use Peregrine™ Sinus Endoscope

FDA clears Boston Scientific’s EXALT Model B Single-Use Bronchoscope

Zoll scores FDA approval for updated sleep apnea implant acquired in...

Volpara Receives FDA Clearance for Breast Density Algorithm

Biofourmis Earns FDA’s First-Ever Breakthrough Device Designation for a Novel Digital...

ARVIS Augmented Reality Gains FDA 510(k) Clearance

Asensus Surgical Receives FDA 510(k) Clearance for Articulating Instruments

LifeSignals remote patient monitor wins FDA clearance

Averto Medical won FDA breakthrough device designation for ColoSeal

CereVasc treats first patient with eShunt system in its STRIDE clinical trial

Onward reports positive spinal cord stim results for ARC-EX

Siemens Healthineers and Sectra strike radiology partnership

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