On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) ...
Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...
Beyond Tariffs: The Software Supply Chain Risks Every Medical Device Manufacturer Should Be Watching
By reframing security as an investment rather than a cost, MDMs can reduce risk exposure, improve compliance readiness, and ...
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves ...
The burgeoning field of Software as a Medical Device (SaMD) offers opportunities for innovation in healthcare monitoring and delivery through mobile apps. Regulatory focus by the FDA on "device ...
DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This intensive four-day ...
Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. Medical device cybersecurity is a dynamic and evolving space. As more devices enter the ...
Medical Device Network on MSN
FDA clears ViTAA Medical’s AI aortic surgery planning tool
ViTAA Medical’s aortic surgery planning tool has gained clearance from the US Food and Drug Administration (FDA), ...
Caranx Medical ("Caranx"), a French medical device company specializing in the development of an autonomous robot to democratize access to Transcatheter Aortic Valve Implantation (TAVI), a lifesaving ...
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