The U.S. FDA has made clear its expectations of batteries and accessories for automated external defibrillators, but at least one maker of replacement AED batteries seems to have not got the message.
The U.S. Environmental Protection Agency’s rulings on ethylene oxide emissions have drawn the ire of the device industry, but the chemical industry has weighed in as well.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Candela, Siemens Healthineers.
More than 18 months after announcing plans to spin off its kidney care division as a standalone public company, Baxter International Inc. reached an agreement to sell the business for $3.8 billion to global equity investor Carlyle and Atmas Health instead. The transaction is expected to close in late 2024 or the first quarter of 2025.
The U.S. FDA warning letter to Globus Medical Inc., highlights some long-running concerns at the agency about medical device reporting practices, but the agency was keen to point to a problem with the company’s complaint trending practices.
Molecular Health GmbH believes that the integration of all the different types of data currently used to aid in the analysis of health conditions will be essential to the future of diagnostics.
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