Signal
53 articles covering "fda"
The Dutch medtech giant cleared a 510(k) for a spectral CT that reconstructs 145 images per second using a deep learning engine, bringing always-on spectral imaging to US hospitals for the first time.
Phase 3 RASolute 302 data show the oral RAS inhibitor extending median overall survival to 13.2 months versus 6.7 months on chemotherapy, sending Revolution Medicines shares up nearly 40 percent.
The first once-weekly treatment for achondroplasia is now commercially available in the United States after Ascendis Pharma secured orphan drug exclusivity through 2033.
Prime Medicine is pursuing accelerated approval for PM359, an autologous prime editing therapy that restored immune function in both patients treated for chronic granulomatous disease, marking the first clinical use of prime editing technology.
Samsung has begun a phased rollout of blood pressure monitoring to US Galaxy Watch owners, classifying the feature as a wellness tool under the FDA's updated General Wellness Policy rather than seeking medical device clearance.
United Therapeutics' miroliverELAP, an external bioengineered liver built on a decellularized pig scaffold seeded with human cells, receives FDA RMAT designation after all five Phase 1 patients survived treatment.
Real-world data from the first year-long implantable CGM arrives as over-the-counter glucose biosensors pivot toward AI-driven wellness coaching, splitting the market between clinical precision and consumer accessibility.
A decade after the first lab-grown brain models, organoid research is crossing from laboratory curiosity to clinical reality, prompting calls for governance frameworks to match the pace of science.
The FDA has accepted Ultragenyx's resubmitted BLA for UX111, a one-time gene therapy for the fatal childhood disease Sanfilippo syndrome Type A, with a decision expected by September 19, 2026.
Three participants in the Acclaim cochlear implant trial have completed their primary 12-month evaluations, bringing the first fully implanted cochlear implant closer to FDA submission.
The FDA has cleared Butterfly Network's Gestational Age Tool, the first blind-sweep ultrasound AI authorized for U.S. marketing, letting any healthcare worker estimate fetal age in under two minutes.
The Eleventh Circuit upholds Florida's cultivated meat ban as Australia launches consumer retail, splitting the global market between expansion and prohibition.