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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submissions for photobiomodulation (PBM) devices — also known as low-level light therapy (LLLT) devices — in a new draft guidance.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 issued separate warning letters to Olympus Medical Systems and its subsidiary Aizu Olympus for failure to report malfunctions of endoscopes and inadequate validations.
Previous treatment options adapted surgical devices developed for adults and this is the first device specifically cleared by the FDA for pediatric use, the company said.
MedAlliance announced that its Selution SLR drug-eluting balloon (DEB) has gained a conditional FDA investigational drug exemption (IDE) for the treatment of coronary de novo lesions, which typically have been treated with stents.
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.”