We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
AtriCure is paying $34 million in stock for California surgical ablation devicemaker Estech, giving the Ohio-based company added clout in the atrial fibrillation market. Read More
eNeura Therapeutics has won FDA approval of its Cerena Transcranial Magnetic Stimulator, the first device approved to relieve pain from migraine headaches. Read More
Sharplight Technologies, an Israeli maker of powered surgical lasers, received an FDA warning letter for failures with quality records and other documents. Read More
The FDA will soon begin identifying candidates for a pilot program whereby manufacturers can opt to self-identify and correct possible regulatory violations and avoid FDA inspection. Read More
Health product safety legislation introduced by Canada’s conservative government would require devicemakers to revise product labels to reflect new risk information, including updates on pediatric warnings, and conduct further tests when issues arise around at-risk populations. Read More
The UK’s National Institute for Health and Care Excellence has given a thumbs up to JOTEC’s heart device to treat complex aneurysms and dissections of the thoracic aorta, saying the technology could reduce the need for additional procedures and the associated risk of serious complications. Read More
Lawmakers in Japan have approved legislation paving the way for a distinct regulatory regime for medical devices. The measure raises industry hopes that long-awaited device regulations will soon follow. Read More
Disagreement among members of the Council of Europe over whether to allow reprocessing of single-use medical devices could hamper efforts to pass device reform legislation before next May’s EU elections. Read More
FDA user fees are protected from sequestration cuts for at least two years under Wednesday’s 64-36 Senate budget vote, which also recommends repeal of the medical device excise tax. Read More