Medical Device Technology
Nebraska Medicine, based in Omaha, Nebraska, however, has begun testing an AI tool in two of its primary care clinics to detect diabetic retinopathy in patients — a condition that can lead to blindness.
The recent CES 2024 show (formerly the Consumer Electronics Show) produced a number of health care-related, attention-getting devices. Some are not commercially available yet, but these products have the potential to help patients take greater control of their health.
The Government Accountability Office Dec. 21 recommended the Food and Drug Administration and Cybersecurity and Infrastructure and Security Agency update a 5-year-old agreement regarding medical device security.
The Food and Drug Administration on Nov. 16 announced a new report from government contractor MITRE, Next Steps Toward Managing Legacy Medical Device Cybersecurity Risks.
On Oct. 31 at 1 p.m. ET, the Food and Drug Administration will host a webinar to review its recent proposed rule for laboratory developed tests, which would amend the agency’s regulations to require most laboratory developed tests to meet the same medical device requirements as other in vitro…
The Food and Drug Administration the week of Aug. 7 cleared for marketing the first sterilization system for 3D-printed devices in health care facilities.
The Environmental Protection Agency today proposed requiring commercial sterilization facilities to comply within 18 months with stricter emission and control standards for ethylene oxide (EtO), a type of gas used to sterilize certain medical devices that cannot be sterilized using alternative…
Effective today under the Consolidated Appropriations Act of 2023, medical devices seeking approval from the Food and Drug Administration must meet certain cybersecurity requirements if they connect to the internet and contain software and technological characteristics vulnerable to cybersecurity…
Philips has reported two potential issues with Respironics Trilogy ventilators that were recalled in June 2021 and reworked, the Food and Drug Administration announced last week. The silicone sound abatement foam used to replace the polyester-based polyurethane foam may separate from the plastic…
The FDA revised its emergency use authorizations for all COVID-19 antigen tests to authorize serial testing and require updates to product labeling regarding serial testing, and designated the recall of 60,500 filters used in breathing systems a Class I recall.