Echosens SA obtained clearance from the U.S. FDA to expand the indications for screening with its Fibroscan system. The approval removes contraindications for pregnancy and active implant and includes patients with confirmed or suspected liver disease. It designates Fibroscan as a noninvasive aid for clinical management, diagnosis and monitoring of adult and pediatric patients with liver diseases. The age has been removed as the first selection probe and exam-type step.
Batteries used in medical devices don’t always perform as expected, but Abbott Laboratories has issued an advisory to users of its Freestyle glucose monitoring systems in connection with overheating of the batteries used in the device’s readers, a problem the company said is not related to the batteries themselves. Abbott Park, Ill.-based Abbott has received reports of battery swelling and overheating in the reader unit, but advised users that use of non-Abbott charging cables seems to drive the risk of such episodes, urging users to stick with the USB charging cables that came with the readers.
The U.S. FDA has wrapped up an October 2015 draft guidance for animal studies for medical devices, which prompted some lengthy responses from stakeholders concerned about some unique terms, such as device “handling.” Despite industrial opposition to the inclusion of that term, the final guidance retains the term handling and defines it in part as the manner in which the device “responds to the demands of the operator,” a term that may or may not be encompassed by the FDA’s overarching policy for human factors engineering.
Okwin Inc. is leading a consortium of hospitals and pathology labs from across France as part of a €33 million (US$36 million) project to develop and deploy new digital pathology artificial intelligence (AI) tools to improve cancer care. The project, called Portrait, is backed by the French government, and the hope is that by producing more efficient and accessible diagnostic tools, clinicians will be able to better tailor treatments to individual patients at an earlier stage of the disease.
Heartflow Inc. is feeling the love of investors again as it closed a $215 series F financing round led by Bain Capital Life Sciences. The round marks a return to the equity markets after several years away; the company closed its series E in 2017 and a $65 million venture round in 2019. In early 2022, Heartflow scrapped its plans to go public through a special purchase acquisition company (SPAC) merger with Longview Acquisition, citing what both companies called “current unfavorable market conditions.” Longview had offered $690 million in July 2021, in a deal that implied an enterprise value of $2.4 billion at the time.
Medtronic plc and Davita Inc. launched a new company this week centered on the assets and capabilities of Medtronic’s former Renal Care Solutions (RCS) division. Mozarc Medical US LLC brings Medtronic’s strategic plan to streamline its operations by spinning off several divisions one step closer to fruition.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Edap Tms, Icentia, Restor3d.
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