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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelabio, Acorai, Alimentiv, Corundum Neuroscience, Edetek, Joy Ventures, Kinetic River, Medidata Solutions, Monteris Medical, Neuraxis, Parse Biosciences, Pharmanest, Spinco Biotech, Stimvia, Venturemed. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Recor. Read More
