For individuals with major depressive disorder (MDD) that does not respond to pharmacotherapy, recent decisions by the U.S. FDA enabling at-home use of neuromodulation devices may provide a bright spot in dark days. Neurolief Inc. received FDA approval for Prolivrx, a physician-directed, brain neuromodulation therapy indicated for use as an at-home adjunctive treatment for adults with MDD who failed to respond adequately to at least one previous antidepressant on Jan. 7. That decision follows the December 510(k) clearance for at-home use of the Flow Neuroscience AB’s Flow brain-stimulation device as either a monotherapy or as an adjunctive treatment.

Edwards scraps Jenavalve buy in face of FTC objections

Edwards Lifesciences Corp. said it plans to scrap its plans to acquire Jenavalve Technology Inc. for $945 million after a federal court ruled against the company in a case brought by the U.S. Federal Trade Commission (FTC) to block the deal. Edwards reported that the U.S. District Court for the District of Columbia had granted the motion from the FTC for an injunction blocking the company’s proposed acquisition of Jenavalve, which is developing transcatheter aortic valve replacement devices targeted at aortic regurgitation. In statement, Edwards said it disagrees with the decision and believes that the acquisition would have been in the best interest of a large, growing and underserved group of patients.

Cellbxhealth restructures to grow

Cellbxhealth plc, previously called Angle plc, appointed Peter Collins, its CEO, along with several non-executives, to its board as it embarks on a new strategic direction. Over the past few months, the company has overhauled its management team, reduced its workforce by 60% and raised £8.2 million (US$11 million) as it changes focus from research to commercialization of its Parsortix system, a platform that captures and harvests circulating tumor cells.

MHRA opens pilot for small firms registering clinical device studies

The U.K. Medicines and Health Care Products Regulatory Agency provided an update on its guidance for clinical investigations for medical devices, such as a new set of documents required to register a study. Perhaps of greater interest for smaller companies in the med-tech industry is that the agency is offering a waiver of the fee for registration of these studies, but interested parties have only until March 31, 2026, to obtain the waiver.

TGA considers a policy dealing with device shortages

The COVID-19 pandemic amplified concerns over medical device shortages, prompting the U.S. FDA to develop guidance on the topic in November 2023. Australia’s Therapeutic Goods Administration is eyeing a guidance to address the very same problem, although the agency seems wary of whether to formally develop a guidance on device shortages.

Med-tech gainers and losers for Jan. 5-9, 2026

The top 10 med-tech stock gainers and losers for the week.

Also in the news

Abbott Labs, AI4eyes, Bayer, Boston Scientific, Brainsway, Caris Life Sciences, Dentsply Sirona, Edwards, Everlywell, Hello Heart, Henry Schein, Hummingbird Diagnostics, Hydrix, Intermountain Health, Major Medical Devices, Medicines360, Medtronic Diabetes, Nanochon, Neuraxis, Neurolief, Orchestra Biomed, Oxford Nanopore, Perimeter Medical Imaging, Renata Medical, SS Innovations, Syncardia, Teleflex, Treace, Valencia Technologies, Ventaris Surgical