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Fda Approval

All articles tagged with #fda approval

Boston AI startup forecasts breast cancer risk from mammograms before tumors form
technology1 day ago

Boston AI startup forecasts breast cancer risk from mammograms before tumors form

Boston-based Clairity, led by radiologist Dr. Connie Lehman, has FDA authorization to use an AI system that analyzes mammograms to predict a woman's risk of developing breast cancer, enabling preventive actions and tailored screening. Trained on over 400,000 mammograms with five-year follow-ups and tested on 77,000 images, the deep neural network outperformed traditional risk calculators and could expand to younger ages and more diverse populations, though the model remains a 'black box' in parts; investors include ACE Global Equity and Santé Ventures as Boston's health-tech scene grows.

via The Boston Globe|
#ai-in-healthcare#boston-tech-scene#breast-cancer
FDA Approves Wearable TTFields Therapy for Locally Advanced Pancreatic Cancer
health4 days ago

FDA Approves Wearable TTFields Therapy for Locally Advanced Pancreatic Cancer

The FDA approved Optune Pax, a wearable device delivering abdominal tumor treating fields (TTFields) to treat locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel, based on PANOVA-3 which showed longer median overall survival and pain-free survival with TTFields versus chemotherapy alone; skin reactions were common; the device costs about $21,000 per month and includes patches, a generator, and support services.

via Medscape|
#fda-approval#health#novocure
Wegovy Goes Oral: New Pill Delivers Similar Weight-Loss Benefits as Injection
health1 month ago

Wegovy Goes Oral: New Pill Delivers Similar Weight-Loss Benefits as Injection

The FDA has approved Wegovy as an oral pill for adults, delivering the same active ingredient (semaglutide) as the weekly injection. Because the pill must pass through the digestive system, it’s taken once daily on an empty stomach with a full glass of water and a 30‑minute wait before eating. The pill uses a higher daily dose (25 mg) than the injection (2.4 mg weekly), and trials suggest similar weight‑loss results between forms (about 13.9% with the pill vs 14.4% with the injection). Side effects are primarily gastrointestinal for both forms. The pill is not yet approved for adolescents (12+), can be stored at room temperature, and costs and insurance coverage may influence which form a patient chooses.

via Live Science|
#fda-approval#glp-1#health
Novo Nordisk Launches Wegovy as First Oral Weight-Loss Pill in the U.S.
health1 month ago

Novo Nordisk Launches Wegovy as First Oral Weight-Loss Pill in the U.S.

Novo Nordisk has launched an oral version of its weight-loss drug Wegovy in the U.S., offering a convenient alternative to injections. The pill, containing semaglutide, was approved by the FDA in December and is available for $149 per month for initial doses, with prices increasing later in April. Clinical trials show significant weight loss benefits, making it a notable innovation in obesity treatment.

via CBS News|
#fda-approval#health#novo-nordisk
FDA Approves Wegovy as First Oral Weight-Loss Pill
health2 months ago

FDA Approves Wegovy as First Oral Weight-Loss Pill

The FDA has approved the first daily oral medication version of Wegovy, a popular weight-loss drug, giving Novo Nordisk an advantage over Eli Lilly, whose similar drug is still under review. The pill, containing semaglutide, has shown significant weight loss in clinical trials and is expected to be available soon, potentially expanding access and reducing costs for obesity treatments.

via CBS News|
#fda-approval#health#novo-nordisk