FDA - Food and Drug Administration
FDA clears AI model to triage urgent CT findings, Israeli firm says
Aidoc won FDA clearance for a 'foundation model' clinical AI that triages 14 abdomen-CT indications in one workflow, aiming to surface urgent findings faster amid ED crowding and imaging backlogs.
FDA clears first US trial of Israel’s EndoArt synthetic corneal implant
Arizona couple admits in court to faking cancer-curing 'smart chip' device
Forget the injections: The FDA has approved a daily weight-loss pill for the first time
FDA approves 'donanemab' treatment for Alzheimer's disease
The drug contains an antibody that aims to slow the progression of the incurable Alzheimer’s disease. It operates by eliminating the buildup of amyloid protein plaque in the brain.
Nicotine-like chemicals in US vapes may be more potent than nicotine, FDA says
6-methyl nicotine in vapes, potentially more addictive than traditional nicotine, is unregulated by the FDA, prompting concerns and calls for regulation due to unknown health risks.
FDA approves the first fully autonomous AI for portable diabetic retinopathy screening
AEYE Health's FDA-cleared AI, AEYE-DS, enables autonomous diabetic retinopathy screening using handheld cameras, revolutionizing eye care accessibility and outcomes.
Israel’s Immunai could be the secret weapon to faster drug approvals
American-Israeli company announces latest success story with AstraZeneca.
Imagindairy gets FDA approval to introduce animal-free dairy proteins to US market
The company’s animal-free dairy proteins replicate the taste, texture, functionality, and nutritional value of traditional cow's dairy proteins.
FDA greenlights new obesity treatment
Preliminary studies have shown Eli Lilly's injection's ability to reduce body weight by up to 26%. The drug is already approved in Israel for diabetes.
Blood tests needed for widespread Alzheimer’s diagnosis on the way
Blood testing is initially likely to be used to rule out Alzheimer’s, with positive results signaling the need for more advanced diagnostics.
Brooklyn kosher ice cream chain recalls all of its frozen desserts due to listeria fears
The recall also applies to Ice Cream House frozen products sold in grocery stores.
Israeli firm gets FDA approval for rectum shield that blocks radiation
When implanted and inflated, the device creates a consistent, reliable, and reproducible space between the prostate and rectum.
Alzheimer's diagnosis revamp embraces rating scale similar to cancer
The new guidelines are intended for doctors to use in clinical practice, for the first time offering patients treatments that can slow the course of the disease, rather than just treat symptoms.
