Device Directive News Today

/PRNewswire/ -- First quarter Net sales reached SEK 9.4 (13.0) million. The operating result totaled SEK -18.4 (-14.4) million. Earnings per share, basic and...

AI MEDICAL SERVICE INC. hereinafter AIM a medical startup specializing in the development of diagnostic endoscopic AI is excited to announce the first instance of Singaporean regulatory review and device registration for an AIbased endoscopic diagnostic support device that operates within the stomach brand name Endoscopic image diagnosis support software gastroAImodel G.

AI Medical Service Inc. Completes First Regulatory Review and Device Registration of Gastric AI-based Endoscopic Diagnosis Support System from Singapores HSA

- The endoscopic AI differentiates gastric lesions as neoplastic or non-neoplastic -TOKYO--(BUSINESS WIRE)--AI MEDICAL SERVICE INC. (hereinafter AIM), a medical start-up specializing in the development of diagnostic endoscopic AI, is excited to announce the first instance of Singaporean regulatory review and device...

– Completion of the European Union Medical Device Regulation final audit is the last step in obtaining an MDR certificate and CE marking, confirming Femasys’ compliance with the highest required...

The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation...

The European Union's Health Commissioner today proposed pushing back the deadline for its new medical device regulation (MDR) law.

In May 2021, the EU MDR replaced the EU's Medical Device Directive and Directive on Active Implantable Medical Devices. Learn about the basics of...

PathFlow® Viewer and Automated Workflow Now European Regulatory Cleared for Use in Primary Diagnosis*SPOKANE, Wash., Oct. 9, 2022 /PRNewswire/ -- Gest

/PRNewswire/ -- Gestalt Diagnostics, Inc., a leading provider of award-winning digital pathology solutions, announced today that it has received CE-IVD marks...