A number of recent developments in artificial intelligence (AI) have sent some reassurance that these algorithms will not hit the market completely devoid of regulation, but a Nov. 8 hearing in the U.S. Senate makes clear that Capitol Hill is intent on legislating on AI, even if only belatedly.
Acutus Medical Inc. revealed plans after the Nasdaq closing bell on Nov. 8 to abandon the electrophysiology business as part of a massive restructuring that will leave the company entirely committed to manufacturing and distribution of Medtronic plc’s left-heart access products. The shift will put 65% of Acutus employees out of work and leaves the future of its cardiac ablation and mapping products up in the air.
Recor Medical Inc. finally received U.S. FDA approval for its Paradise ultrasound renal denervation (RDN) system for the treatment of hypertension after more than ten years of research and clinical trials. Paradise is the first RDN system to reach the U.S. market, and its approval is good news for the technology after years of disappointment in the data from trials and concerns over the efficacy of RDN devices.
The Alzheimer’s Drug Discovery Foundation (ADFF)’s Diagnostic Accelerator launched the first longitudinal, international study of vocal changes associated with Alzheimer’s disease (AD). Part of a $100 million effort to develop affordable biomarkers for AD, the study hopes to create the world’s largest database of speech and vocal data to facilitate diagnosis and monitoring of neurodegenerative disease.
Carrying through on a policy it adopted a few months ago to crack down on potentially anticompetitive FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process.
Johnson & Johnson expects to submit the long-awaited Ottava robotic surgical system to the U.S. FDA for an investigational device exemption (IDE) in the second half of 2024, nearly three years later than the company anticipated when its Ethicon Inc. unit acquired Ottava along with Auris Health Inc. in 2019.
The acquisition of Icad Inc.’s brachytherapy business by Elekta AB takes the company a step closer to achieving its goal of providing hope to the millions of people dealing with cancer, John Lapré, president of Elekta’s Brachy and Neuro Solutions unit, told BioWorld. Elekta paid approximately $5.5 million for Icad’s subsidiary Xoft. In addition, most of Xoft’s staff and its main facility in San José, Calif., was transferred to the company.
As reported ipreviously in coverage by BioWorld, the U.S. FDA’s latest guidance on cybersecurity elevates the agency’s demands for medical device cybersecurity, but the agency advised industry in a recent webinar that hospital IT systems are fraught with cybersecurity hazards of their own, and thus device makers should view these IT systems as potentially hostile environments where cybersecurity is concerned.
With the use of 3D printing and microfluidics, Fertilis Pty Ltd. hopes to triple the success rates of in vitro fertilization (IVF) by improving embryo quality and quantity.
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