Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ensodata, Virtual Incision.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agiliti, Diacarta, Natera, Oncoassure, Pulmonx, Quanterix, Retrieve.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Icecure, Laplace Interventional, Orchestra Biomed.
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.
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.
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.
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.
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