Abbott Laboratories received FDA 510(k) clearance for the Ensite X EP system with Ensite omnipolar technology, the company’s cardiac mapping platform. The system, which is used to identify and treat abnormal heart rhythms such as atrial fibrillation, produces detailed three-dimensional maps of the heart to guide physicians performing ablation procedures.
A panel of leaders in women’s health at the 2022 edition of the J.P. Morgan Healthcare Conference addressed the challenges and benefits of digital health and new apps in enabling women to be the “chief medical officers” of their families’ health and to take the necessary steps to improve their own. The panel included moderator Lynne Chou O’Keefe, founder and managing partner of Define Ventures; Apple Inc.’s Vice President of Health Sumbul Ahmad Desai; Veronica Gillispie-Bell, assistant professor, Ochsner Health System; Found CEO Sarah Jones Simmer; Michelle Williams, dean of faculty at the Harvard T.H. Chan School of Public Health; and Tia Inc. CEO and co-founder Carolyn Witte.
Two med-tech giants GE Healthcare Ltd. and Boston Scientific Corp. are teaming up to expand cardiac care in Southeast Asia. GE Healthcare and Boston Scientific reported plans to collaborate on an end-to-end cardiac care solution offered to cardiac care centers in Southeast Asia. The suite of care offered ranges from diagnostic to percutaneous coronary intervention.
The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus.
Medtronic plc continued its aggressive acquisition strategy today with the announcement of an agreement to purchase Affera Inc. Medtronic Chairman and CEO Geoff Martha revealed in a presentation on Jan. 10 at the virtual edition of the J.P. Morgan Healthcare Conference that his company was paying $925 million for the cardiac mapping and navigation company. The total reflects $250 million in payments assuming Affera meets “contingent considerations.”
The U.K. National Institute for Health and Care Excellence (NICE) has recommended the use of the Kardiamobile as an option for detecting atrial fibrillation (AF) events in patients diagnosed with suspected paroxysmal AF. Alivecor Inc., of Mountain View, Calif., is the obvious beneficiary of the recommendation, a good bit of news given the company’s struggles to maintain patent protection for its products.
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