PMA, and DeNovo submissions to bring medical devices to the US market. Recent 510(k) modifications for new technologies and safety advancements, along with AI integration, present significant ...
Navigate opportunities in the evolving EU and UK medical device markets by understanding the MDR/IVDR regulations. Gain insights into UK regulatory changes, anticipate future digital medicine ...
In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...
DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...
MINNEAPOLIS, July 19, 2024 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, ...
SAN FRANCISCO, Jan. 03, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (IRTC) (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and ...
Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...
January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...
LONDON--(BUSINESS WIRE)--Signifier Medical Technologies Limited (“Signifier”), a global leader in medical technology for sleep-disordered breathing, announces that it has achieved the EU MDR ...
DONGGUAN, GUANGDONG, CHINA, January 13, 2026 /EINPresswire.com/ -- As healthcare increasingly shifts towards at-home ...
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