fda

The FDA proposes further restrictions to sales of flavored e-cig products

The FDA has drafted new guidance for the regulation of e-cigarettes, particularly with regards to flavored nicotine products. The first big change is that the FDA has bumped up the application due dat

National Cancer Institute chief tapped as acting FDA Commissioner

In the wake of FDA Commissioner Scott Gottlieb’s abrupt resignation, Secretary of Health and Human Services Alex M. Azar III announced that Dr. Ned Sharpless will serve as interim commissioner o

FDA approves esketamine nasal spray, the first new major depression drug in more than 30 years

In one of the most significant milestones for depression treatment in decades, the U.S. Food and Drug Administration announced today that it has approved a new drug with esketamine, a derivative of ke

FDA Commissioner Scott Gottlieb abruptly resigns from his post

That was unexpected, including by the FDA, apparently. FDA Commissioner Scott Gottlieb resigned today, an administration official tells The Washington Post, adding that Gottlieb will relinquish the of

FDA warning brings controversial young blood transfusion company to a halt

On Tuesday, the FDA issued a warning to anyone who might be inclined to give their old bones a jolt with fresh blood harvested from the young. The idea is pretty far from mainstream, even in Silicon V

Biotech AI startup Sight Diagnostics gets $27.8M to speed up blood tests

Sight Diagnostics, an Israeli medical devices startup that’s using AI technology to speed up blood testing, has closed a  $27.8 million Series C funding round. The company has built a desktop m

Healthcare wearables level up with new moves from Apple and Alphabet

Announcements that Apple has partnered with Aetna health insurance on a new app leveraging data from its Apple Watch and reports that Verily — one of the health-focused subsidiaries of Google&

What the FDA’s restriction of e-cig flavors means for Juul

FDA Commissioner Scott Gottlieb has revealed his plans to combat underage use of e-cigs and nicotine, which has grown 78 percent among high school students from 2017 to 2018. The commissioner today an

How the Apple Watch changed the world

In 2015 Switzerland was fucked. This blunt belief, grunted out by Apple’s Jony Ive and repeated by the media as a death knell for the watch industry, seemed to define a sad truth: that the Swiss

Bose hearing aid gets FDA approval

For the 37.5 million adults who have trouble hearing without a hearing aid, Bose has a new product for you. The U.S. Food and Drug Administration today approved audio technology company Bose to marke

Juul files lawsuit against other e-cig makers for patent infringement

Juul Labs today filed a complaint with the United States International Trade Commission (ITC) claiming that several organizations are infringing on Juul Labs’ patents. Juul has asked the ITC to

FDA seizes thousands of documents from e-cig startup Juul

E-cigarette maker Juul recently received a surprise visit from the Food and Drug Administration, CNBC first reported. Last week, the FDA seized thousands of documents from the startup’s headquar

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
Load More