FDA
Emerging Tech

The FDA approves special contact lenses that turn dark on sunny days

The U.S. Food and Drug Administration has given its stamp of approval to contact lenses which darken or lighten depending on how much ultraviolet radiation they come into contact with.
Mobile

KardiaBand helps the Apple Watch inch closer to becoming a medical device

While those fitness bracelets and smart watches can help improve your health, they're no substitute for real medical devices. But now, the FDA approved the first medical device accessory for the Apple Watch.
Health & Fitness

The FDA may be reversing its stance on e-cigarettes and vapes

The FDA noted a pretty significant change in its e-cigarette policy, which includes relaxing restrictions on these kinds of products (its previous policy might've rendered them nearly obsolete)
Health & Fitness

After an FDA probe, St. Jude rolls out an update fixing the Merlin@home issue

After reports claiming hackers can break into Merlin@home monitors and reprogram St. Jude implants, the FDA conducted an investigation. Now an update is currently rolling out to the monitors and St. Jude's Merlin.net network to address the…
Computing

FDA issues final guidelines on keeping medical devices safe from cyberattack

Malware aimed at medical devices is particularly dangerous, and so the Food and Drug Administration (FDA) has singled out medical devices as being worthy of special protection against cyberattack,
Health & Fitness

FDA easing access to hearing aids and assistance devices for everyone over 18

The FDA announced effective immediately it will not enforce hearing aid regulations for people 18 and older. Medical evaluations or waivers will not be required to buy hearing aids. The FDA committed to "consider" a category of OTC hearing…
Health & Fitness

FDA states it will not regulate fitness trackers and wellness apps

App and product developers can rest easy after the FDA released recommendations indicating the agency will not regulate low-level wellness and fitness products, including fitness trackers, weight management applications, and meditation…
Emerging Tech

The FDA approved this ‘stomach pump’ implant, and doctors aren’t happy about it

The FDA-approved AspireAssist weight-loss device allows obese patients to pump food from their stomach, through a tube, out their belly, and into the toilet without being fully absorbed.
Web

Rise in popularity of online vision exams has your local eye doctor seeing red

The American Optometric Association is ready to wage war against online vision exams, with its initial target being Chicago-based startup Opternative. The AOA describes these types of services as the "corporate equivalent of snake oil…
Emerging Tech

The pipe dream is over: FDA regulates vaping

The U.S. Food and Drug Administration announced that it would begin regulating all tobacco-related products including cigars, pipe tobacco, hookah tobacco, and e-cigarettes. This new rule will have a profound effect on the e-cig and vaping…
Emerging Tech

The world's tiniest pacemaker is no bigger than a vitamin, and it was just approved by the FDA

Micra Transcatheter Pacing System, the world's smallest pacemaker, just received FDA approval. It is one-tenth the size of traditional devices and measures about the size of a large vitamin, so it is easy to implant and can last for more…
Health & Fitness

The FDA wants medical device manufacturers to be proactive about cybersecurity

To address the potential dangers of connected medical devices, the FDA has recently released a draft guidance aimed at helping medical device manufacturers keep their patients safe and the public health protected.