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The FDA issued a proposed rule aimed at modernizing mammography quality standards and better positioning the agency to act when violations are found. Read More
The FDA is considering a total product lifecycle monitoring approach to emerging artificial intelligence devices, the agency said in a proposed rulemaking issued April 2. Read More
The FDA issued a new draft guidance laying out how the agency is updating uniform inspections—other than for-cause inspections—to reflect the FDA Reauthorization Act of 2017. Read More
The SEC claimed Fresenius failed to take steps to curb misconduct, such as providing proper anti-corruption training or performing due diligence on its agents. Read More
Healthcare company MedStar Health will pay $35 million to settle claims that it made illegal kickbacks to a cardiology group in exchange for referrals for various cardiovascular procedures including implants of medically unnecessary stents. Read More
A key advisory group to the European Commission called for urgent clarification of certain device exemptions under Article 54(2) b of the EU’s Medical Device Regulation (MDR). Read More