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Medtech Medical Devices

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

Lunit's Groundbreaking AI Research Transforms Medical Pathology with Computer Vision, Presented at CVPR 2023

Lunit (KRX:328130.KQ), a leading global provider of AI-powered cancer diagnostic solutions, announced its participation in the Conference on Computer...

June 13, 2023 | News

Translumina bolsters its German presence with acquisition of Lamed GmbH

Established in 1989, Lamed is a leading market access platform of vascular and cardiovascular products. It covers 1,000+ hospitals through its GPO network ...

June 07, 2023 | News

Seegene Obtains IVDR Certification for 30 Diagnostic Assays

Seegene certifies diagnostic assays for digestive, respiratory, women's diseases, and human papillomavirus to meet IVDR requirements New regulation...

June 02, 2023 | News

Lunit and the JNCCHE Partner in AI Pathology to Advance Precision Oncology

Lunit (KRX:328130.KQ), a global provider of AI-powered cancer diagnostic solutions, today announced collaboration with the National Cancer Center...

May 31, 2023 | News

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