A look at the possible impact of SCOTUS overturning Chevron deference and curbing federal agencies' power on net neutrality, Big Tech regulation, and more
Since the New Deal era, the bulk of the functioning US government is the administrative state — think the acronym soup of agencies like the EPA, FCC, FTC, FDA, and so on.
The US FDA approves Apple Watch's AFib history feature for clinical studies, the first digital health tech qualified under the FDA's MDDT program
The FDA today announced that it has qualified the Apple Watch AFib ( Atrial Fibrillation) history feature as an MDDT (Medical Device Development Tools).
The US FDA warns the agency has not “authorized, cleared, or approved any smartwatch or smart ring” that claims to measure blood glucose levels non-invasively
As Apple Reportedly Tests Blood Sugar Tech X: @fdadeviceinfo : We issued a safety communication to warn that smartwatches and smart rings claiming to measure blood glucose levels without piercing the ...
The FDA says approval for medical devices now requires meeting certain cybersecurity standards issued in the omnibus spending bill signed in December 2022
The Food and Drug Administration affirmed Wednesday that medical device manufacturers must now prove their products meet certain …
Sources: the FDA rejected Neuralink's clinical trial application, citing dozens of issues to fix before human testing, like the device's removal and its battery
Musk has said his brain implant company, Neuralink, will make the paralyzed walk, the blind see and eventually turn people into cyborgs.
Fitbit receives FDA clearance for passive heart rhythm monitoring to detect signs of atrial fibrillation (AFib) and will roll out the feature in the US soon
The Food and Drug Administration has given Fitbit the green light to monitor users' heart rhythms in the background.
FDA says Medtronic is recalling some insulin pumps that connect wirelessly to other insulin equipment because they can't be updated to address security flaws
Kate Fazzini / CNBC :
FDA says Medtronic is recalling some insulin pumps that connect wirelessly to other insulin equipment because they can't be updated to address security flaws
KEY POINTS — “MiniMed 508” Medtronic insulin pumps have cybersecurity problems that can't be updated or patched …
FDA approves first digital pill, which has an embedded sensor that will show doctors whether and when patients are taking it, sparking privacy concerns
For the first time, the Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether …
Verily, Apple, Fitbit, and Samsung are among nine firms chosen for FDA pilot program for faster approval of digital health tools
Anna Edney / Bloomberg :