Category: CERTIFICATIONS - Page 85 - Start Medical Product Development

RIVANNA’s next-generation ultrasound guidance platform and AI-driven imaging software receive FDA 510(k) clearance

July 16, 2025

CHARLOTTESVILLE, Va., July 16, 2025 /PRNewswire/ — RIVANNA®, developers of world-first imaging-based medical technologies, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) regarding the Accuro® 3S diagnostic ultrasound system and SpineNav-AI™ image processing software. This clearance authorizes the use of both technologies in United States hospital and clinical settings, providing anatomical guidance during needle or catheter placement.

Arthrex NanoScope™ System Receives Pediatric Clearance for Orthopedic, Laparoscopic Procedures

July 16, 2025

NAPLES, Fla., July 16, 2025 /PRNewswire/ — Arthrex, a global leader in minimally invasive surgical technology, announced that it has received U.S. Food and Drug Administration (FDA) clearance to use the Arthrex NanoScope™ operative arthroscopy system for pediatric orthopedics and laparoscopy.

CVRx announces Medicare win for Barostim therapy

July 16, 2025

CVRx (Nasdaq:CVRX) announced today that CMS proposed to keep its Barostim implant procedure within a certain payment class.

HistoSonics Secures Expanded Insurance Coverage for Liver Tumor Therapy

July 15, 2025

Non-Invasive Histotripsy Treatment Now Accessible to 7 Million Blue Cross Blue Shield Highmark Members Across U.S.

VitalFlow™ ECMO System Earns CE Mark, Strengthening Medtronic’s Cardiac Portfolio

July 15, 2025

The CE Mark approval of the VitalFlow™ ECMO System marks a significant advancement in extracorporeal life support, delivering enhanced precision and control for managing critically ill cardiac and respiratory patients.

Johnson & Johnson MedTech gets updated FDA nod for Varipulse PFA

July 14, 2025

Johnson & Johnson MedTech (NYSE: JNJ)+
today announced FDA approval for an update to its Varipulse platform’s irrigation flow rate.

Scopio Labs Receives Fourth FDA Clearance, Elevating Digital Morphology with Enhanced AI-Powered RBC and Platelet Capabilities

July 10, 2025

TEL AVIV, Israel, July 10, 2025 /PRNewswire/ — Scopio Labs, a trailblazer in Full-Field Digital Cell Morphology, today announced another significant milestone: its fourth U.S. Food and Drug Administration (FDA) clearance (K243144). This latest clearance introduces powerful new Decision Support System (DSS) features to its X100 and X100HT platforms and Peripheral Blood Smear (PBS) Application, further transforming the way laboratories analyze red blood cell (RBC) morphology and identify platelet clumps in peripheral blood smears.

Blog

- CERTIFICATIONS

RIVANNA’s next-generation ultrasound guidance platform and AI-driven imaging software receive FDA 510(k) clearance

Arthrex NanoScope™ System Receives Pediatric Clearance for Orthopedic, Laparoscopic Procedures

CVRx announces Medicare win for Barostim therapy

HistoSonics Secures Expanded Insurance Coverage for Liver Tumor Therapy

VitalFlow™ ECMO System Earns CE Mark, Strengthening Medtronic’s Cardiac Portfolio

Johnson & Johnson MedTech gets updated FDA nod for Varipulse PFA

Scopio Labs Receives Fourth FDA Clearance, Elevating Digital Morphology with Enhanced AI-Powered RBC and Platelet Capabilities

U.S. FDA Grants Breakthrough Device Designation to Artera’s AI-Powered Prostate Cancer Decision Support Tool

SimBioSys Earns Third FDA Clearance for TumorSight™ Viz

FDA clears Intuitive curved vessel sealer device for surgical robot