Becker's Spine Review1d
7 spine, orthopedic devices earning FDA clearance in 1 month
Discover the latest FDA-cleared orthopedic and spine devices and technologies, including robotics, implants, and bone graft systems.
Becker's Hospital Review1d
FDA spotlights risks in medical device supply chain
The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.
JD Supra3d
FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support ...
ophthalmologyadvisor3d
FDA Alerts: Ophthalmology Drug and Device Approvals
FDA alerts and updates on the latest drug and device approvals, recalls, and other regulatory developments in ophthalmology.
Radical Catheter Technologies’ 8F Neurovascular Catheter Receives US FDA 510(k) Clearance, Second for the Best-in-Class Ribbon Technology Platform
I am pleased with the growth and accomplishments related to the Company’s key strategic objectives to set a new standard in neurovascular access and delivery,” said Brian Martin, co-founder and CEO of ...
JD Supra4d
FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, ...