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The FDA offers advice for 510(k) marketing submissions for photobiomodulation (PBM) devices — also known as low-level light therapy (LLLT) devices — in a new draft guidance.
An administrative law judge in Washington D.C., has ruled that certain Apple watches, starting with 2020’s Series 6 and continuing through current versions, infringe on pulse oximeter patents held by Masimo. The U.S. International Trade Commission will now consider whether to implement a ban on imports of the watches.
The FDA has closed out a warning letter sent to Dayton, Ohio-based Innovative Sterilization Technologies (IST) in 2019 for marketing a reusable sterilization container for uses the agency had not cleared, the company said.
The company seeks to replace pulse oximeters to measure oxygen levels of sepsis, trauma, and cardiac surgery patients who are “on the verge of organ failure.”
An independent committee of the UK’s National Institute for Health and Care Excellence (NICE) has proposed that England’s National Health System (NHS) use hybrid closed-loop systems for managing difficult to control blood glucose levels in type 1 diabetics.
The European Commission has extended the transition period for manufacturers to comply with the Medical Devices Regulation (MDR), citing the limited capacity of notified bodies to ensure “a successful transition to the new regulatory framework.”