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FDA issues 510(k) clearance for Getinge’s Talis +ACG software
Medical Device Network via Yahoo Finance· 6 days agoIn April 2024, Getinge obtained a European Union Medical Device Regulation certificate for its...
Clario secures FDA 510(k) clearance for SpiroSphere with wireless ECG
Medical Device Network via Yahoo Finance· 5 days agoLast year, Clario introduced the ECG Quality Score tool, which is powered by AI, for improving...
Co-Diagnostics seeks FDA clearance for COVID-19 test By Investing.com
Investing.com· 4 days agoCo-Diagnostics , Inc. (NASDAQ:CODX), a molecular diagnostics company, has announced the completion...
Merit Medical (MMSI) Recalls Syringes Made by Jiangsu Shenli
Zacks via Yahoo Finance· 12 hours agoThe basixSKY is the latest addition to Merit Medical’s comprehensive inflation device portfolio,...
Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro Platform
KPVI· 5 days agoFood and Drug Administration (FDA) application for 510(k) clearance for the Co-Dx™ PCR Pro™ instrument, and the Co-Dx ...
Avicenna.AI wins FDA clearance for vertebral compression fracture tool
Medical Device Network via Yahoo Finance· 6 days agoArtificial intelligence (AI) imaging company Avicenna.AI has bagged 510(k) clearance from the US...
Roche receives FDA clearance on its digital pathology solution for diagnostic use
Lodi News-Sentinel· 22 hours agoThe solution, which includes the VENTANA DP 200 slide scanner, Roche's digital pathology workflow software and a display, is now cleared to aid in clinical diagnosis, enabling pathologists to ...
Philips' (PHG) Diagnosis & Treatment Segment Drives Growth
Zacks via Yahoo Finance· 11 hours agoRecently, Philips launched an AI-enabled cardiovascular ultrasound platform with FDA 510(k) ...
Exactech Announces First Shoulder Surgeries Using Comprehensive Trauma Shoulder Plates
Williamson Daily News· 7 days agoGAINESVILLE, Fla., June 12, 2024 /PRNewswire/ -- Exactech, a global medical technology leader,...
Co-Diagnostics Submits At-Home PCR System, COVID-19 Test to FDA
GenomeWeb News· 4 days agoCo-Diagnostics announced on Friday that it has submitted a PCR instrument and COVID-19 test to the US Food and Drug Administration for 510(k) clearance ...