Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Huxley Medical, Signifier Medical Technologies.
Globus Medical Inc. reported it is buying Nevro Corp. in an all-cash transaction. Under the terms of the agreement, which was unanimously approved by the boards of both companies, Globus will acquire all shares of Nevro for $5.85 per share. The transaction represents a total equity value of approximately $250 million.
The U.S. FDA’s device center hasn’t issued news bulletins or guidances in the past week, but the march of device recalls continues apace in the month of February.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angle, Heartbeat Health, Hinge, Neufit, Rapidai, Screenpoint Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10x Genomics, Axena Health, Bracco Imaging, Cortechs.ai, Dariohealth, Dexcom, Edap Tms, Ultima Genomics, Glooko, Innovation Zed, Liva, Onc.AI.
When the U.S. CDC and FDA recently removed several webpages and datasets from their websites in compliance with a directive from the Office of Personnel Management, they broke the law and harmed public health and research, according to a lawsuit filed Feb. 4 by Doctors for America.
Site neutral payments under the U.S. Medicare program have been contentious for some time, and Congress seems poised to act on the issue in 2025. The Medicare Payment Advisory Commission is wary of making any recommendations as yet — a position that MedPAC may hold pending the collection of additional data.
Medicare Advantage plans have drawn criticism for deviating somewhat from Medicare coverage policies, a question CMS took up in a recent draft rule. In comments to the docket, the Medical Device Manufacturers Association said it sees a need to throw a lasso around such practices, alleging that they may result in beneficiaries receiving more limited coverage than they would in fee-for-service care.
As pulsed field ablation transformed the electrophysiology market over the last year, Boston Scientific Corp. emerged as the biggest winner by far. In its fourth quarter earnings call on Wednesday, the company quantified just how successful its Farapulse PFA system has been.
In the first patenting from Lent Innovations LLC, the company’s founder, Anne Lent – an allergist and immunologist – describes their invention of an epinephrine auto-injector tailored to the specific needs of children to reduce the risk of use errors and incorrect injection technique.