The EU’s proposed orphan and breakthrough device designations would formalise accelerated regulatory pathways for high-need medical technologies, with significant implications for conformity ...

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 ...

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 ...

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 ...

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 ...

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 ...

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" ...

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 ...

DMHTs sit within a broader wave of digital health technologies, helping manage a range of issues such as asthma with smart ...