Category: CERTIFICATIONS - Page 3 - Start Medical Product Development

Spectrum Dynamics Medical Receives FDA 510(k) Clearance for Veritas.AI™, Its AI-Powered Noise Reduction Platform for VERITON-CT

January 29, 2026

SARASOTA, Fla., Jan. 29, 2026 /PRNewswire/ — Spectrum Dynamics Medical, a global leader in digital nuclear medicine imaging solutions, today announced that it has received FDA 510(k) clearance for Veritas.AI™ Noise Reduction, its advanced artificial intelligence platform designed to significantly enhance image quality, diagnostic confidence, and operational efficiency on the VERITON-CT® digital SPECT/CT system.

Glucotrack picks up new patents for continuous blood glucose monitor

January 29, 2026

Glucotrack (Nasdaq:GCTK) announced today that it received new U.S. patents for its continuous blood glucose monitoring (CBGM) platform.

RevBio receives FDA clearance for cranial bone glue trial

January 29, 2026

The FDA has authorised up to 15 clinical sites to take part in the study.

Siemens Healthineers wins FDA nod for PET/MR imaging scanner

January 29, 2026

Siemens Healthineers announced today that it received FDA clearance for its Biograph One second-generation PET/MR scanner.

Senseonics wins CE mark for Eversense 365 year-long CGM

January 29, 2026

Senseonics (NYSE:SENS) announced today that its Eversense 365 continuous glucose monitor (CGM) system received CE mark approval.

Seno Medical’s Next-Generation Imagio® Imaging System Obtains European Union (EU) Medical Device Regulation (MDR) CE Mark Certification

January 28, 2026

The CE Mark certification enables Seno Medical to market and sell the latest version of its Imagio® Imaging System with opto-acoustic, sound, and artificial intelligence in the European Union.

Glaukos gets FDA nod for iDose TR re-administration

January 28, 2026

Glaukos (NYSE:GKOS) announced today that the FDA approved a new drug application (NDA) labeling supplement for its iDose TR system.

FDA clears eMurmur’s next-gen AI heart murmur detection software

January 28, 2026

eMurmur has received FDA 510(k) clearance for its next-generation heart murmur detection software, eMurmur Heart AI (2.2).

ABANZA Secures FDA 510(k) Clearance for QuadLock™ Fixation System for ACL Reconstruction

January 27, 2026

ORLANDO, Fla., Jan. 27, 2026 /PRNewswire/ — ABANZA, a company focused on next-generation soft-tissue repair solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for QuadLock™, its new knotless, bidirectional tension-adjustable fixation system for ACL reconstruction.

Outset Medical wins FDA nod for next-gen Tablo hemodialysis system

January 27, 2026

Outset Medical (Nasdaq: OM)+
announced today that it received FDA 510(k) clearance for its next-generation Tablo hemodialysis platform.

Blog

- CERTIFICATIONS

Spectrum Dynamics Medical Receives FDA 510(k) Clearance for Veritas.AI™, Its AI-Powered Noise Reduction Platform for VERITON-CT

Glucotrack picks up new patents for continuous blood glucose monitor

RevBio receives FDA clearance for cranial bone glue trial

Siemens Healthineers wins FDA nod for PET/MR imaging scanner

Senseonics wins CE mark for Eversense 365 year-long CGM

Seno Medical’s Next-Generation Imagio® Imaging System Obtains European Union (EU) Medical Device Regulation (MDR) CE Mark Certification

Glaukos gets FDA nod for iDose TR re-administration

FDA clears eMurmur’s next-gen AI heart murmur detection software

ABANZA Secures FDA 510(k) Clearance for QuadLock™ Fixation System for ACL Reconstruction

Outset Medical wins FDA nod for next-gen Tablo hemodialysis system