The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics. Read More
In recent years, the U.S. Congress has come to rely unduly on continuing budget resolutions to fund government operations, and fiscal year 2024 is no exception. The current continuing resolution (CR) for the FDA budget is set to expire March 1, but there is concern that Congress will resort yet again to a CR to cover the balance of fiscal 2024, a predicament which suggests that the FDA’s appropriations may be flat relative to fiscal year 2023. Read More
Early-stage health care companies developing breakthrough medical technologies were given some good news recently with the launch of a new accelerator program by Israel’s Arc Innovation aimed at giving startups a $250,000 cash injection. With a $10 million investment from Ilex Medical Ltd., the initiative is looking to empower early-stage companies by providing financial backing, expert guidance and a support network. Read More
With the number of people with dementia in Australia expected to nearly double by 2054, the federal government is funding a new AU$50 million (US$32.76 million) biomedical and med-tech incubator program to develop new therapies, medical devices and digital health technologies to address dementia and cognitive decline. Read More
Australia’s Therapeutic Goods Administration (TGA) proposed in July 2023 to develop a framework for audits for premarket device applications, but the Medical Technology Association of Australia (MTAA) registered several concerns about the proposal. Read More
Discover a wealth of industry insights with BioWorld’s extensive collection of infographics, covering the latest trends and developments in both biopharma and med-tech. Our weekly infographics are curated to provide concise summaries of key topics: financings (IPOs, private financings, public/other and follow-on offerings), deals and M&As (top deals, and monthly value and volume), regulatory (including U.S. FDA and worldwide approvals), clinical trials and more. In addition, you’ll find access to BioWorld’s year-in-review reports, as well as special infographics about obesity, pain and addiction, biosimilars and the aging space. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Icecure, Laplace Interventional, Orchestra Biomed. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agiliti, Diacarta, Natera, Oncoassure, Pulmonx, Quanterix, Retrieve. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ensodata, Virtual Incision. Read More
