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The FDA Just Cleared the Dexcom G7 15-Day, the Longest-Lasting CGM

The new sensor — expected to launch in the second half of 2025 — will provide easier diabetes management for eligible users. [...]

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The FDA rolls out its own AI to speed up clinical reviews and scientific evaluations

The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we're living in a time of widespread disinforma [...]

Match Score: 63.59

Destination
Oura Ring 4 long-term review: Out ahead of its rivals

Smart rings have been a niche inside a niche in the wearables world for more than a decade. But in the last few years, they’ve enjoyed a renaissance as more attention and hype brought bigger names t [...]

Match Score: 49.54

thenextweb
The FDA just picked its first company to sell an unauthorised device to Medicare patients

The US Food and Drug Administration named Dexcom as the first manufacturer selected for its Technology-Enabled Meaningful Patient Outcomes pilot on Tuesday. The programme, known as TEMPO, allows dig [...]

Match Score: 49.01

Destination
FDA employees say the agency's Elsa generative AI hallucinates entire studies

Current and former members of the FDA told CNN about issues with the Elsa generative AI tool unveiled by the federal agency last month. Three employees said that in practice, Elsa has hallucinated non [...]

Match Score: 45.90

Destination
FDA approves world’s first dual-sensor CGM in diabetes 'breakthrough' — new Libre Duo sensor tracks ketones and blood sugar in real-time

The FDA has greenlit the first CGM wearable to monitor both blood sugar and ketone levels simultaneously. [...]

Match Score: 44.71

Destination
The FDA and EU clear Nuance Audio, smart glasses with built-in hearing aids, for sale

Nuance Audio, new "hearing glasses" from EssilorLuxottica, have received FDA clearance and "a CE marking under the Medical Devices regulation in the EU," making them officially rea [...]

Match Score: 41.02

Destination
Apple Watch Series 11 receives FDA clearance for hypertension alerts

Apple's Awe Dropping event started with dramatic health testimonials from Apple Watch users, then revealed a key new feature for the new Watch Series 11: hypertension alerts. The function had yet [...]

Match Score: 40.88

Destination
The FDA clears the first blood test for diagnosing Alzheimer's disease

There's a new way to screen for early detection of Alzheimer's disease. On Friday, the Food and Drug Administration (FDA) cleared the first blood test for the disorder. Fujirebio Diagnostics [...]

Match Score: 37.43

Destination
The FDA approves human trials for pig kidney transplants

Despite how it sounds, a xenotransplant isn't something from the latest Alien movie. It's an increasingly credible science: the transplantation of animal organs into humans. The field took o [...]

Match Score: 37.34