FDA
Emerging Tech

That bleeding vegetarian burger from Impossible Foods is now FDA-approved

Impossible Foods created a vegetarian burger that "bleeds" just like a real, juicy, half-pounder does. This week, the FDA determined that the key ingredient in Impossible Foods' veggie burger poses no risk to our health.
Smart Home

CDC reports first death from E. coli outbreak tied to romaine lettuce

The CDC has reported the first death from the major E. coli outbreak associated with romaine lettuce from the Yuma, Arizona, winter lettuce growing region. Last month more than 200 million eggs from a North Carolina farm were recalled.
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.
Health & Fitness

Bad news, college students: Pizza boxes contain toxic chemicals

Pizza lovers, college students, and Americans everywhere, take note -- the Food and Drug Administration has just banned three chemicals found in food packaging, most notably the all-important pizza box.
Emerging Tech

FDA approves use of bioengineered Herpes virus as cancer treatment

On the heels of a favorable recommendation by EU drug reviewers, the US Food and Drug Administration this week approved a novel viral drug therapy for cancer, known chemically as talimogene laherparepvec, or T-Vec.
Health & Fitness

23andMe receives limited approval from FDA to work in US

23andMe is returning to the U.S. after a two year ban from the FDA. The privately held company plans to offer 35 of the 250 tests in the country, and is planning a new marketing run in the U.S. to kickstart sales.
Emerging Tech

The first FDA-approved 3D-printed drug dissolves almost instantly in water

After months of testing, the US Food and Drug Administration has given its seal of approval to a new drug called Spritam (levetiracetam) -- a rapid-dissolving 3D-printed tablet designed for the treatment of epileptic seizures.