EPA Sets Tougher Limits on Gas Used to Sterilize Medical Devices
Health
EPA Sets Tougher Limits on Gas Used to Sterilize Medical Devices
2024-03-15 19:11:47
by Dan McCue

WASHINGTON — The Environmental Protection Agency on Thursday finalized tougher restrictions on ethylene oxide, a cancer-causing gas commonly used to sterilize medical devices. The new standards specifically target commercial sterilization facilities. The agency called them “the strongest measures in U.S.... Read More

FDA, Veterans Health Administration Partner to Accelerate Medical Device Innovation
Health
FDA, Veterans Health Administration Partner to Accelerate Medical Device Innovation
2022-09-28 19:27:00
by Dan McCue

WASHINGTON — The Food and Drug Administration and the Veterans Health Administration have entered into a new level of collaboration intended to help accelerate American medical device innovation.  Under the auspices of a memorandum of understanding signed last week, the... Read More

FDA Readies to Regulate AI and Machine Learning in Medical Devices
Technology
FDA Readies to Regulate AI and Machine Learning in Medical Devices
2021-05-17 17:36:01
by Daniel Mollenkamp

The U.S. Food and Drug Administration has set its sights on the issue of artificial intelligence and machine learning in medical devices. Experts now say that the agency will need to open up a specific regulatory pathway for these devices... Read More

FDA Greenlights Record Number of Medical Devices
FDA Greenlights Record Number of Medical Devices
2021-02-18 20:18:43
by Daniel Mollenkamp

WASHINGTON - In a public health milestone, the Food and Drug Administration announced on Tuesday that it approved a record setting amount of novel medical devices in 2020.  In 2020, the FDA’s Center for Devices and Radiological Health gave the... Read More

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