fda

Not to be overshadowed by the Apple Watch, AliveCor announces a new 6-lead ECG reader

Apple’s announcement last week of a Watch with an FDA-approved ECG reader to track heart health looked to be the undoing of original ECG reader company AliveCor. But, to prove it still has a hea

Natural Cycles contraception app told to clarify pregnancy risks

A multi-month investigation by Sweden’s Medical Products Agency into a number of unwanted pregnancies among users of ‘digital contraception’ app Natural Cycles has been closed afte

Apple’s Watch isn’t the first with an EKG reader but it will matter to more consumers

Apple’s COO Jeff Williams exuberantly proclaimed Apple’s Watch was the first to get FDA clearance as an over-the-counter electrocardiogram (EKG) reader during the special event at Apple headqu

Fitbit stock sinking following Apple Watch announcement

Apple announced its latest and greatest Apple Watch in Cupertino today — The Apple Watch Series 4.  Fitbit (NYSE: FIT) stock sank as a result. Right now it’s down more than 6 percent and

The clock is ticking for e-cig companies to block underage users

The FDA is giving makers of e-cigarettes 60 days to come up with a more effective, forceful plan to combat underage use of the products. FDA Commissioner Dr. Scott Gottlieb is yet again moving the goa

Unbound makes pleasure fashionable

Unbound founders Polly Rodriguez and Sarah Jayne Kinney have long and varied careers. Rodriguez worked for U.S. Senator Claire McCaskill on Capitol Hill before heading to Deloitte Consulting and dati

Contraception app Natural Cycles’ Facebook ad banned for being misleading

Natural Cycles, a Swedish startup which touts its body temperature-based algorithmic method for tracking individual fertility as an effective alternative to hormonal birth control, has been wrapped by

JUUL Labs responds to FDA concerns about flavored e-liquids

In a statement released today, Juul Labs has responded to FDA moves to increase regulation on flavored tobacco products in order to curb underage use. This comes at a time when Juul Labs is under incr

With CBD, marijuana-based medicine gets its first greenlight from the FDA

In a news release today, the FDA announced its approval of a marijuana-derived drug called Epidiolex for the treatment of seizures in a subset of patients suffering from severe epilepsy. Epidiolex co

Juul tightens up social media to focus on former smokers switching to e-cigs

Juul Labs, the company behind the ever-popular Juul e-cig, has today announced a new policy around social media. This comes in the midst of Juul’s effort to get FDA approval, which has been made

Cognoa's AI platform for autism diagnosis gets first FDA stamp

Cognoa has gained regulatory recognition for its machine learning software as a class II diagnostic medical device for autism -- meaning the digital health startup is now positioned to submit an appl

FDA clears AliveCor’s Kardiaband as the first medical device accessory for the Apple Watch

The Food and Drug Administration has just cleared AliveCor’s Kardiaband EKG reader as the first medical device accessory for the Apple Watch. Europe has been able to use a version of the Kardiab

Peter Thiel backs offshore human testing of experimental herpes vaccine

Peter Thiel and a group of libertarians are funding an offshore human clinical trial of a herpes vaccine, skirting FDA regulations and sparking a heated debate over U.S. safety rules.

Omega Ophthalmics is an eye implant platform with the power of continuous AR

Google and other tech companies have come up with glasses and contact lenses for the purposes of AR, but Omega Ophthalmics is taking a much more invasive approach by using surgically implanted lenses

A year with the PAX Labs Juul vaporizer

Nicotine vaporizer companies have a bit of a conundrum. While, legally, they can’t market themselves as smoking cessation devices, most vapers are current or former cigarette smokers. In fact, t

9 promising at-home lab test startups for everything from fertility to STDs

It’s easier than ever to skip the doctor and go straight for the at-home test these days, thanks to updated regulations and the technology to match — and for many, it’s the answer to

FDA issues new security guidelines so that your pacemaker won’t get hacked

This week, the US Food and Drug Administration issued a set of recommendations for securing medical devices that could jeopardize the safety and privacy of their users. The report, titled “Postm

FDA finds flaws in Theranos’ Zika tests

This past week, the U.S. Food and Drug Administration mandated testing for the Zika virus at all U.S. blood centers. That juices demand for Zika-testing technology, but one company that isn&#821

What the Fitbit lawsuit means for clinical researchers

Fitbit is facing a class-action lawsuit regarding the accuracy of their heart-rate data, which have been shown to be inaccurate by a margin of up to 20 beats per minute. This news risks sending back t

Unpacking the innards of Theranos’s new Zika-detection box

Theranos has had a long 10 months. The company, beset with regulation issues, has faced a Congressional inquiry, possible criminal charges, lawsuits, a recall of test results from the past two years,
Load More