FDA Archives

Blackversion PRO

Main Website
News Home
Funding
- Axial3D secures $18m in equity funding
  
  Funding December 20, 2024
  
  Precision Neuroscience raises $102M to support BCI
  
  Funding December 19, 2024
  
  Flow Medical secures $2m to advance breakthrough thrombolysis catheter for pulmonary embolism treatment
  
  Funding December 18, 2024
  
  Fluid Biomed raises $27m to advance ReSolv brain aneurysm stent
  
  Funding December 17, 2024
Clinical Trials
- CathWorks completes enrolment in CAD treatment system trial
  
  Clinical Trials January 6, 2025
  
  Navigantis achieves 1st cases with VASCO Neurovascular surgical robot
  
  Clinical Trials January 6, 2025
  
  SamanTree Medical’s Histolog scanner shows promise in breast surgery outcomes
  
  Clinical Trials December 16, 2024
  
  Protaryx Medical completes first-in-human trial of transseptal puncture device
  
  Clinical Trials December 12, 2024
Innovation
- Verathon launches sustainable single-use laryngoscope
  
  Innovation November 29, 2024
  
  VUZE Medical demonstrates new multi-tool 3D guidance in spine surgery
  
  Innovation November 28, 2024
  
  Globus Medical launches ExcelsiusHub navigation system
  
  Innovation November 27, 2024
  
  Vascular stent graft maker Solaris Endovascular launches to address vascular health challenges
  
  Innovation November 14, 2024
Regulatory Approvals
- The FDA clears Magstim Horizon INSPIRE TMS system
  
  Regulatory Approvals January 6, 2025
  
  FDA grants IDE approval for the pivotal trial of Roivios’ JuxtaFlow® renal assist device
  
  Regulatory Approvals December 20, 2024
  
  Onward wins FDA De Novo classification for non-invasive spinal cord stimulation system
  
  Regulatory Approvals December 20, 2024
  
  HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance
  
  Regulatory Approvals December 18, 2024
Mergers & Acquisitions
- DHG boost market-leading pressure ulcer prevention portfolio with Sumed acquisition
  
  Mergers & Acquisitions October 18, 2024
  
  Wellvii, B-Secur partner to integrate ECG into at-home monitoring tech
  
  Mergers & Acquisitions October 4, 2024
  
  Flat Medical acquires InjeQ’s IQ-Tip needle system
  
  Mergers & Acquisitions September 30, 2024
  
  Vitalograph acquires respiratory diagnostics company Morgan Scientific
  
  Mergers & Acquisitions September 25, 2024
Featured

Guided Solutions - Connecting Talent With Innovation

/div>

Axial3D secures $18m in equity funding

Precision Neuroscience raises $102M to support BCI

Flow Medical secures $2m to advance breakthrough thrombolysis catheter for pulmonary embolism treatment

Fluid Biomed raises $27m to advance ReSolv brain aneurysm stent

CathWorks completes enrolment in CAD treatment system trial

Navigantis achieves 1st cases with VASCO Neurovascular surgical robot

SamanTree Medical’s Histolog scanner shows promise in breast surgery outcomes

Protaryx Medical completes first-in-human trial of transseptal puncture device

Verathon launches sustainable single-use laryngoscope

VUZE Medical demonstrates new multi-tool 3D guidance in spine surgery

Globus Medical launches ExcelsiusHub navigation system

Vascular stent graft maker Solaris Endovascular launches to address vascular health challenges

The FDA clears Magstim Horizon INSPIRE TMS system

FDA grants IDE approval for the pivotal trial of Roivios’ JuxtaFlow® renal assist device

Onward wins FDA De Novo classification for non-invasive spinal cord stimulation system

HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance

DHG boost market-leading pressure ulcer prevention portfolio with Sumed acquisition

Wellvii, B-Secur partner to integrate ECG into at-home monitoring tech

Flat Medical acquires InjeQ’s IQ-Tip needle system

Vitalograph acquires respiratory diagnostics company Morgan Scientific

Tag: FDA

Zebra Medical earns its stripes with FDA nod for AI to...

Paige Receives First Ever FDA Approval for AI Product in Digital...

Theraclion Receives FDA Approval for SONOVEIN Trial

Gynesonics Announces FDA Clearance of Next Generation Sonata System

inTRAvent’s Bedside Neuro-Navigation Device Receives FDA 510(k) Clearance

FDA Grants Breakthrough Device Designation to the NovoTTF-200T™ System for Advanced...

FDA clears MiRus expandable lumbar system

Asensus Surgical nabs third FDA clearance of 2021, this time for...

FDA approves first vagus nerve stimulation implant for stroke rehabilitation

Fuse Medical, Inc. Announces FDA 510(k) Clearance of the Sterizo™

CathWorks completes enrolment in CAD treatment system trial

Navigantis achieves 1st cases with VASCO Neurovascular surgical robot

The FDA clears Magstim Horizon INSPIRE TMS system

FDA grants IDE approval for the pivotal trial of Roivios’ JuxtaFlow® renal assist device

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

Editors’ Choice: Q1 2024 in MedTech