Medtronic plc's cryoablation could soon put drug therapy on ice in parts of the atrial fibrillation (AF) market, based on results of studies published in the New England Journal of Medicine (NEJM) and presented at the American Heart Association Scientific Sessions 2020.

The question of whether the U.S. FDA will review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic has bounced around frequently in recent weeks, and Brett Giroir of the Department of Health and Human Services has resurrected the issue.

The European Commission has awarded the CE mark to Hologic Inc. for its Genius Digital Diagnostics system for cervical cancer screening. According to the company, it is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to assist cytotechnologists and pathologists in detecting precancerous lesions and malignant cells in women.

Boston Scientific Corp. said it is initiating a global, voluntary recall of all unused inventory of the Lotus Edge aortic valve system, blaming complexities associated with the product delivery system. The Marlborough, Mass.-based company emphasized that the valve itself continues to achieve positive and clinically effective performance post-implant. However, because of the time and investment needed to develop and reintroduce a delivery system, the company believes it is necessary to retire the entire Lotus platform immediately.