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Medical Devices

BD Receives 510(k) Clearance for COVID-19, Influenza A/B, RSV Molecular Combination Test

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k)...

August 02, 2023 | News

FDA Clears Terumo's Reveos® Automated Whole Blood Processing System for U.S. Commercial Use

Terumo Blood and Cell Technologies (Terumo BCT) announces U.S. Food and Drug Administration (FDA) clearance of the Reveos Automated Whole Blood Processing ...

August 02, 2023 | News

FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

The FDA clearance also includes the company's core technology platform, the proprietary AXINON® System, that incorporates diagnostic tes...

August 01, 2023 | News

KORU Medical Systems Announces Late-Stage Endocrinological Biologic Collaboration

Under terms of the Agreement, Koru Medical will validate the Freedom Infusion System for use with the company’s drug. The drug developer is expected ...

July 31, 2023 | News

Palliare Announces EU CE Mark Approval Under New Medical Devices Regulation

Palliare, a leading developer of advanced insufflation technologies, has received EU CE Mark certification under the new EU Medical Devices Regulation (MDR...

July 31, 2023 | News

Alma Veil™ Launched for U.S. Market by Sisram Medical's Alma

Alma Veil is the core instrument equipped with three gold-standard technologies conveniently integrated into a single handpiece: 532 nm laser:...

July 26, 2023 | News

Aevice Health Secures US FDA Clearance for Smart Wearable Stethoscope-Enabled Remote Respiratory Monitoring

The AeviceMD received U.S. FDA 510(k) clearance as a Class II medical device. ● The AeviceMD is part of a broader system that continuously monitors bioma...

July 21, 2023 | News

Lunit's AI Solution Impacts Radiologists' Lung Cancer Diagnosis - Published in Radiology

Findings from a recent study demonstrate that medical AI solutions with only high diagnostic accuracy can significantly improve the reading performance of ...

July 04, 2023 | News

Lumos Receives US FDA Clearance for FebriDx®

The clearance allows FebriDx to be marketed in the US for use by healthcare professionals as an aid in the diagnosis of bacterial acute respiratory infecti...

July 04, 2023 | Regulatory

Japan Approves CXR-AID for Reimbursement, Boosting Market Expansion for Lunit

Lunit (KRX:328130.KQ), a global provider of cancer diagnostics solutions, today announced that CXR-AID, FujiFilm's AI solution for chest X-ray analysis, po...

June 27, 2023 | News

South Korea's DeepCatch AI Software Receives US FDA Clearance for Whole-Body CT Quantification

The world's first FDA cleared solution that automatically analyzes bone, muscle, visceral fat, subcutaneous fat, internal organ, and central nerv...

June 27, 2023 | News

United Imaging Unveils Next-Gen PET/CT Systems and Molecular Technology at SNMMI

United Imaging, a global leader in manufacturing advanced medical imaging and radiotherapy equipment and a Leadership Circle sponsor at this year's SNMMI, ...

June 26, 2023 | News

FDA Approves Japan's Cardio Flow Design's Innovative 4D Flow MRI Software

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval is significant as it recognizes the safety...

June 20, 2023 | News

AWAK Technologies, Singapore General Hospital Launch Wearable Dialysis Trial

AWAK PD is a wearable and ultra-portable peritoneal dialysis (PD) system that allows patients with end-stage kidney disease to have dialysis on the go and ...

June 20, 2023 | News

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