fda FDA Clears First Artificial Intelligence Device to Screen for Diabetic Retinopathy The FDA grants rapid approval to the first artificial intelligence device designed to detect diabetic retinopathy without requiring a doctor's interpretation. This breakthrough technology allows non-eye care specialists to screen patients for the leading cause of blindness.
neuralink Neuralink Wins FDA Breakthrough Status, But Blindness Cure Claims Are Premature Neuralink receives FDA breakthrough device clearance for its Blindsight implant, though experts caution this designation does not equate to a proven cure for blindness. The technology still faces significant hardware limitations despite Elon Musk's ambitious public statements.
fda FDA Clears DeepWell Toolkit to Treat Stress With Video Games DeepWell DTx receives FDA clearance for a biofeedback software development kit that allows video games to treat stress and hypertension as over-the-counter supplements. This milestone connects gaming media directly to emerging digital mental health reimbursement streams.
apple Apple AirPods Pro 2 Gain FDA Approval as Over-the-Counter Hearing Aids The FDA grants Apple permission to turn AirPods Pro 2 into clinical-grade hearing aids through a simple software update. This milestone makes the earbuds the first over-the-counter hearing aid software device approved in the United States.
fda FDA Over-the-Counter Hearing Aid Ruling Sparks New Era of Tech Innovation A new FDA ruling allows hearing aids to be sold over the counter, breaking the monopoly of legacy players. Experts predict this change brings massive consumer tech innovation and lower costs for millions of Americans.
johnson and johnson Federal Officials Extend Pause on Johnson & Johnson Vaccine Over Rare Clotting Cases U.S. regulators and an independent expert panel extend a pause on the Johnson & Johnson vaccine after six women develop rare blood clots. Health officials warn the delay leaves vulnerable populations at risk while the White House downplays the impact on overall vaccination goals.
johnson and johnson Federal Panel Delays Decision on Johnson & Johnson Vaccine Pause U.S. health officials extend the pause on the Johnson & Johnson COVID-19 vaccine as an advisory committee requests more time to review rare blood clot cases. The group plans to reconvene within 10 days to issue a formal recommendation.
johnson and johnson CDC Panel Delays Decision on Johnson & Johnson Vaccine Amid Blood Clot Concerns U.S. health officials keep the Johnson & Johnson COVID-19 vaccine on pause after an advisory committee requests more time to review rare but severe blood clot cases. The experts plan to reconvene within 10 days to issue a formal recommendation.
fda FDA and CDC Officials Announce Temporary Pause on Johnson and Johnson Vaccine Federal health agencies issue a temporary halt to the Johnson and Johnson COVID-19 vaccine as they investigate rare blood clot cases. Officials urge the public to remain calm and monitor for symptoms while the review takes place.
pfizer Pfizer Seeks Emergency Approval for Highly Effective COVID-19 Vaccine Pfizer officially asks U.S. regulators for emergency use authorization of its COVID-19 vaccine, which shows 95% effectiveness. Limited vaccine supplies could reach Americans by next month.
pfizer Pfizer and BioNTech Request Emergency FDA Authorization for 95% Effective COVID-19 Vaccine Pfizer and BioNTech officially request emergency use authorization from the FDA for their highly effective COVID-19 vaccine. The companies plan to distribute millions of doses globally within hours of receiving approval.
pfizer Pfizer Seeks Emergency FDA Approval for Highly Effective COVID-19 Vaccine Pfizer and BioNTech officially apply for FDA emergency use authorization for their coronavirus vaccine, which shows 95% efficacy in final trials. If approved, the first doses could reach high-risk Americans by mid-December.
pfizer Pfizer Seeks Emergency FDA Approval for Highly Effective COVID-19 Vaccine Pfizer and BioNTech officially request emergency use authorization from the FDA for their COVID-19 vaccine after clinical trials show 95% effectiveness. The company states it is ready to begin distributing the vaccine within hours of receiving federal approval.
pfizer Pfizer and BioNTech Submit Covid-19 Vaccine for FDA Emergency Authorization Pfizer and BioNTech officially ask the FDA to grant emergency use authorization for their coronavirus vaccine. The request brings the world one step closer to deploying a highly effective shot.
moderna Moderna Covid-19 Vaccine Shows 94.5% Efficacy in Late-Stage Trials Moderna reports that its two-dose coronavirus vaccine demonstrates a 94.5% effectiveness rate in preventing Covid-19. The promising results follow a similar announcement from Pfizer as regulators prepare for fast-tracked emergency approvals.