FDA

Alphabet’s Verily ECG watch gets FDA approval as medical device

Alphabet’s Verily ECG watch gets FDA approval as medical device

Alphabet unveiled Verily Study Watch in 2017, describing it as a smartwatch designed specifically for capturing health data from clinical study participants. The watch has been put to good use in the months since its launch, including in studies involving Parkinson's disease. The wearable features an on-demand ECG device and has just earned FDA approval as a Class II medical device.

Continue Reading

Romaine lettuce E. coli outbreak source identified as California

Romaine lettuce E. coli outbreak source identified as California

Nearly a week after advising the public about another E. coli outbreak, US officials are back with an update: the source of the contaminated products. According to the Food and Drug Administration, the new E. coli O157:H7 strain that has impacted consumers in both the United States and Canada originated from various romaine lettuce farms in California.

Continue Reading

Psilocybin depression treatment gets major new FDA designation

Psilocybin depression treatment gets major new FDA designation

A new therapy for treatment-resistant depression has received a milestone Breakthrough Therapy designation from the Food and Drug Administration (FDA). The new designation is notable for one important reason: the treatment involves psilocybin, the active ingredient found in a variety of mushrooms collectively known as "magic mushrooms."

Continue Reading

Bose over-the-counter hearing aid gets FDA approval

Bose over-the-counter hearing aid gets FDA approval

The Food and Drug Administration has approved a Bose over-the-counter hearing aid product, enabling the company to start marketing the device in the United States. Simply referred to as the Bose Hearing Aid, this device is the first of its kind that is self-fitting, controlled by the user, and approved for marketing in the US.

Continue Reading

Juul marketing materials seized as FDA targets underage vaping

Juul marketing materials seized as FDA targets underage vaping

The Federal Drug Administration has seized more than one thousands documents from e-cigarette company Juul, according to a new report. The documents are said to be related to Juul's marketing practices, the focus being underage vaping and the FDA's ongoing work to address marketing that some companies may be targeting at teens.

Continue Reading

FDA targets teen vape use with major new educational campaign

FDA targets teen vape use with major new educational campaign

Internet users will soon see a variety of digital advertisements targeting teenagers who may be thinking about or currently using e-cigarette devices. The Food and Drug Administration (FDA) announced a new educational campaign today that hopes to curb teen use of liquid nicotine devices, the effort spurred by statistics showing increased vaping activities among adolescents.

Continue Reading

Impossible Burger ‘bleeding’ veggie meat found safe to eat by FDA

Impossible Burger ‘bleeding’ veggie meat found safe to eat by FDA

Impossible Foods, the company behind the realistic meat-free "bleeding" Impossible Burger, has announced FDA recognition of its safety. The company's meat products are produced entirely with plants, its Impossible Burger the most eye-catching -- it can "bleed" like real meat, satisfying those cravings you may otherwise get during the veggie burger transition.

Continue Reading

FDA approves first marijuana-based epilepsy medication

FDA approves first marijuana-based epilepsy medication

The FDA has approved the nation's first medication based on an active ingredient from marijuana. The drug, Epidiolex, is intended to treat seizures resulting from Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy. The medication has been approved for patients aged two years or older and marks the first time the agency has approved a drug derived from cannabis.

Continue Reading

OsteoDetect AI tool finds wrist fractures, gets FDA approval

OsteoDetect AI tool finds wrist fractures, gets FDA approval

The FDA has approved a new artificial intelligence tool called OsteoDetect that helps doctors diagnose wrist fractures. The tool is a computer-aided detection and diagnosis software application that uses AI algorithms to help healthcare providers determine if a wrist fracture is present at a faster rate than traditional diagnostic technologies.

Continue Reading

FDA: 207 million eggs recalled in nine states over salmonella risk

FDA: 207 million eggs recalled in nine states over salmonella risk

Indiana-based Rose Acre Farms is initiating a voluntary recall of more than 207 million eggs out of "an abundance of caution" over salmonella risk, according to the FDA. The eggs may be contaminated with a variety of salmonella called Salmonella Braenderup, which can be fatal in compromised individuals and cause serious illness in otherwise health individuals. The eggs were distributed throughout nine states.

Continue Reading

FDA wants ISPs, social networks to help curb online opioid sales

FDA wants ISPs, social networks to help curb online opioid sales

The FDA wants social media companies like Facebook, as well as Internet service providers, to help deal with illegal online opioid sales. These illegal sales are completed in the absence of a doctor's prescription, helping fuel the opioid epidemic claiming lives across the nation. The FDA desires to "work collaboratively" with the companies to help get preventative actions in place.

Continue Reading

23andMe gets FDA approval for BRCA cancer risk DNA test

23andMe gets FDA approval for BRCA cancer risk DNA test

The FDA has approved a 23andMe's cancer risk test, one that provides the results directly to the consumer rather than to a doctor who would then provide their patient with info. The approval is specifically for the Personal Genome Service Genetic Health Risk (GHR) Report for the BRCA1/BRCA2 test revealing breast, prostate, and ovarian cancer risk.

Continue Reading

1 2 3 4 5 6 7