Exactech Inc., of Gainesville, Fla., decided it will not subject itself to a 10-year corporate integrity agreement with the Office of Inspector General, an understandable move given that the company no longer intends to do business in the U.S. under its old brand.
Withings SA received U.S. FDA clearance for Beamo, its health check-up tool designed to monitor heart and lung function. Described as the ‘thermometer of the future’, Beamo combines the sensors of an electrocardiogram, a stethoscope and a thermometer into a hand-held device to allow users to check their body temperature, cardiac and pulmonary health in less than a minute.
The U.S. Environmental Protection Agency has moved to relax reporting requirements for perfluoroalkyl and polyfluoroalkyl substances used in a variety of applications, including medical devices.
A team of five members of the U.S. FDA staff published a review of the use of AI in health care and concluded that while hallucinations in AI systems can be minimized, the trade-off is that efforts to minimize hallucinations tend to diminish the AI’s performance.
The U.S. House is expected to vote late Nov. 12 on an amended continuing resolution (CR) to end the historic 43-day partial government shutdown. Already passed by the Senate, the CR would fully reopen the government and fund it through Jan. 30. President Donald Trump has said he will sign the CR, which ensures federal employees furloughed during the shutdown will receive back pay and will not be terminated.
Australia’s Therapeutic Goods Administration has made a few adjustments to its advertising guidelines for social media promotions, including the requirement that the manufacturer is responsible for anything posted by influencers who are acting on behalf of the manufacturer.
Magstim Co. Ltd. reported that the U.S. FDA cleared its Magstim Rapid magnetic stimulation system for the treatment of chronic pain. The clearance provides a clinically validated therapy that directly targets neural pathways involved in pain processing to deliver a non-invasive, drug-free treatment for chronic pain.
One of the problems of doing business in the EU is that each member nation has its own more or less unique requirements for clinical trial registration, but the Medical Device Coordination Group may have a solution in the form of a pilot program for harmonized clinical trial registration.
A four-way interagency initiative in South Korea, started in 2020, is working to bolster funding for the local medical device industry and grow homegrown devices for the global market.
The U.K. Medicines and Healthcare Products Regulatory Agency has laid out an approach to medical products for rare diseases, which the agency said afflict 3.5 million U.K. citizens. One of the objectives of this program is to simplify evidence requirements for these therapies with the hope of providing patients with more rapid access to much-needed therapeutic options.
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