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 Ltd. received FDA premarket approval for Proliv Rx, 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 brain-stimulation device by Flow Neuroscience AB as either a monotherapy or as an adjunctive treatment. Read More
Edwards Lifesciences Corp. said it is scrapping 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. Read More
Cellbxhealth plc, previously called Angle plc, appointed CEO Peter Collins along with several non-executives to its board as it embarks on a new strategic direction. Over the past few months the company 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 (CTCs). Read More
The U.K. Medicines and Health Care Products Regulatory Agency provided an update of its guidance for clinical investigations for medical devices and is offering a temporary waiver of the fees for registration of clinical studies to small manufacturers. Read More
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. Read More
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New hires and promotions in the med-tech industry, including: Dentsply Sirona, Hello Heart, Henry Schein, Renata Medical, Teleflex, SS Innovations. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Attralus, Bayer, Boston Sci, Caris Life, Distalmotion, Everlywell, Haemonetics, Hydrix, Medicines360, Neuraxis, Orchestra Biomed, Syncardia, Valencia Technologies, Vivasure. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Neurolief, Oxford Nanopore. Read More
