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Interventional devices for heart rhythm disorders and neurovascular care, device software and assays featured among the top buyout announcements of medical device companies in 2022 — led by the Johnson & Johnson (J&J) $16.6 billion Abiomed purchase.
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submissions for photobiomodulation (PBM) devices — also known as low-level light therapy (LLLT) devices — in a new draft guidance.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.