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BioWorld - Tuesday, July 14, 2026
Home » Topics » Medical technology

Medical technology
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Hundreds of medical devices vulnerable to cyber attacks

June 18, 2013
By Amanda Pedersen

Report from Europe: EDAP redeems all $8M of its outstanding debt

June 18, 2013

Washington roundup: New ACC/AHA guide offers docs a more precise roadmap

June 18, 2013
By Mark McCarty

Product Briefs:

June 17, 2013

Financings roundup: Echo Therapeutics reveals pricing for public offering

June 17, 2013

Agreements/contracts: Luminex collaborates with NMTC on medicine panel

June 17, 2013

People in the News:

June 17, 2013

Med-Tech Notes:

June 17, 2013

Keeping you up to date on recent developments in neurology

June 17, 2013

Washington roundup: FDA hints at statutory fix for 510(k) changes issue

June 17, 2013
By Mark McCarty
FDA's stakeholder meeting on the 510(k)-changes issue offered a range of views, but the agency's representatives indicated their interest in the issue has not waned despite pushback from Capitol Hill last year. FDA's Michael Ryan, a regulatory advisor, said the current regulatory regime "is a little open to interpretation" as to what sort of changes might trigger a new 510(k) filing, and indicated the agency will press the matter with Congress by remarking that some of the changes FDA would make to a 1997 guidance could require new legislation.
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