aha.org13h
FDA warns of potential to miss notifications on smartphone-compatible diabetes devices
The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...
TCTMD14h
FDA Issues Early Alert About Risks of Peripheral Atherectomy Device
Fractures and breakages of the helix on the Rotarex system has led to 30 serious injuries, four deaths, and 115 interventions ...
FDA clears migraine device for children as young as 8
A device long used by adults to manage migraines was now available for children as young as eight years old, offering new ...
FDA approves wearable infusion device for advanced Parkinson disease
The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only ...
JD Supra4d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
The National Law Review18d
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
You are responsible for reading, understanding, and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy ...
Reuters18d
FDA approves standalone use of J&J's ketamine-derived depression treatment
Jan 21 (Reuters) - The U.S. Food and Drug Administration expanded approval for Johnson & Johnson's (JNJ.N), opens new tab nasal spray, Spravato, to allow it to be used as a standalone treatment ...
The Irish Times19d
Cork medtech Cergenx secures FDA support for neonatal brain injury device
The United States’s Food and Drug Administration (FDA), which regulates all medicines and medical devices in this key market, has now granted Breakthrough Device Designation for the Wave device.
Becker's Hospital Review21d
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.
ABC News21d
RFK Jr. petitioned FDA in 2021 to revoke authorization of all COVID vaccines
The petition, first reported by the New York Times, asked the Food and Drug Administration to "revoke Emergency Use Authorizations for existing COVID vaccines and refrain from approving and ...
Smithsonian Magazine22d
FDA Bans Red Dye No. 3 From Food, Beverages and Ingested Drugs, Citing Link to Cancer in Lab Rats
Andia/Universal Images Group via Getty Images After decades of debate, the Food and Drug Administration (FDA) has announced a ban on Red Dye No. 3, a synthetic food coloring that’s been linked ...
Forbes22d
FDA’s Red Dye No. 3 Ban, Explained—What It Means For Food And Trust
Red Dye No. 3, or erythrosine, is a synthetic red food dye once popular in candies and cakes. The ... [+] FDA bans Red Dye No. 3 under the Delaney Clause, citing cancer risks observed in lab ...