The US Food and Drug Administration (FDA) is seeking industry comment on practical approaches towards measuring and evaluating the performance of AI-enabled medical devices in the real world. With a ...
The agency is looking for ways to detect, assess and mitigate changes to the performance of AI-enabled devices over time.
Rocket Doctor has entered into a reseller agreement with Remmie, Inc., maker of the Remmie 4, an FDA approved and Health Canada Medical Devices Establishment Licence (MDEL) cleared USB-smart otoscope ...
Quantum computing may sound theoretical, but the implications are very real and fast-approaching, and medical device manufacturers need to start taking action. This piece outlines what PQC is, where ...
Distalmotion announced today that it received FDA 510(k) clearance for the use of its Dexter robotic surgery system in hysterectomy.
By Lori Solomon HealthDay ReporterWEDNESDAY, Oct. 1, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, ...
The federal government seized over $86 million in vape devices in September, the largest seizure of its kind. Recent federal actions are leaving some smoke and vape shops facing uncertainty about ...
Shutting pregnant women out of clinical trials to protect them and their babies has had the opposite effect, experts say.
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How Do These New FDA-Approved Eyeglasses Treat Myopia?
It is now approved as a new treatment option designed to both correct myopia, which is nearsightedness and slow its progression in children between age 6 to 12. What Is Myopia?As pr the National Eye ...
Veteran health care also continues during a shutdown. Veterans Affairs medical centers and outpatient clinics will be open, and VA benefits will be processed and delivered. Burials will continue at VA ...
The discoveries and progress in medicine, biology, and chemistry in the last decades have revolutionized diagnostic and therapeutic methodologies for a large plethora of biomedical applications.
Gleghorn, an associate professor of biomedical engineering, was named to the first cohort of Innovation Ambassadors at UD, as part of the University’s effort to foster and support an innovation ...
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