Category Archives: fda

Risks and rewards of digital therapeutics in treating mental disorders

Madeline Stein & Michael Stein Contributor Share on Twitter Madeline Stein is a first year Doctorate student at Saybrook University studying Applied Psychophysiology within the College of Integrative Medicine and Health Sciences. Michael Stein (@MichaelStein16) is an attorney and angel investor, with a focus on technology companies that want to make the world a better place. More Americans than ever before are suffering from mental and emotional distress. In the U.S., the mental health problem is exacerbated by issues across infrastructure, government, and culture. However, because the […]

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What top VCs look for in women’s fertility startups

A number of promising women’s health tech companies have popped up in the last few years, from fertility apps to ovulation bracelets — even Apple has jumped into the subject with the addition of period tracking built into the latest edition of the watch. But there hasn’t been much in the way of innovation in women’s sexual health for decades. In-vitro fertilization (IVF) is now a 40-year-old invention and even the top pharmaceutical companies have spent a pittance on research and development. Subjects like polycystic ovarian syndrome, […]

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Dear Hollywood, here are 5 female founders to showcase instead of Elizabeth Holmes

Joseph Flaherty Contributor Joe Flaherty is director of Content & Community at Founder Collective. More posts by this contributor Why the ‘end of the startup era’ could be great for entrepreneurs Invisible unicorns: 35 big companies that started with little or no money There’s a seemingly insatiable demand for Theranos content. John Carreyrou’s best-selling book, “Bad Blood,” has already inspired an HBO documentary, The Inventor; an ABC podcast called The Dropout, a prestige limited series starring SNL’s Kate McKinnon, was just announced; and Jennifer Lawrence is reportedly going to star in the feature […]

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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 date by one year for FDA approval of flavored products. Manufacturers of all flavored ENDS (electronic nicotine delivery system) products will now have to submit premarket applications by August 8, 2021. The second change is introducing a new compliance policy with regards to flavored ENDS products. At the time that the current compliance policy was […]

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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 machine, called OLO, that analyzes cartridges manually loaded with drops of the patient’s blood — performing blood counts in situ. The new funding is led by VC firm Longliv Ventures, also based in Israel, and a member of the multinational conglomerate CK Hutchison Group. Sight Diagnostics said it was after strategic investment for the Series C — specifically […]

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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 announced a plan that would remove all flavored electronic nicotine delivery system products — with the exception of tobacco, mint, menthol or non-flavored products — from any store where children under the age of 18 can see them. So what does this mean for Juul, a company that reached a $10 billion valuation 4x faster […]

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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 goal posts for e-cig companies. He now considers underage use of electronic nicotine delivery systems (ENDS) an epidemic, forcing the government to make a choice that we all knew was coming: save the smokers or save the kids? “I believe in the power of American ingenuity to solve a lot of problems, […]

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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 more arduous by the fact that the FDA has cracked down on Juul after learning how popular the device is with underage users. As part of the new policy, Juul will no longer feature models in pictures posted on Instagram, Twitter, or Facebook. FWIW, Juul doesn’t even have a Snapchat. Instead of using […]

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