Category Archives: Food and Drug Administration

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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FDA chief summons Altria and JUUL to Washington to discuss teen vaping

The head of the U.S. Food and Drug Administration is calling Altria and Juul to meet in Washington to discuss their tie-up and how it impacts the companies’ plans to combat teen vaping. Earlier this year, Altria  href=”https://techcrunch.com/2018/12/20/juul-labs-gets-12-8-billion-investment-from-marlboro-maker-altria-group/”>invested $12.8 billion investment in Juul. “After Altria’s acquisition of a 35 percent ownership interest in JUUL Labs, Inc., your newly announced plans with JUUL contradict the commitments you made to the FDA,” Commissioner Scott Gottlieb wrote in a strongly worded letter addressed to Altria chairman and chief executive, Howard […]

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Lack of transparency in healthcare startups risks another Theranos implosion

Are more Theranos -style scandals looming for investors in healthcare startups? A team of researchers associated with the Meta-Research Innovation Center at Stanford thinks so. They’ve published a paper warning investors in life sciences startups that a systemic lack of transparency exists in their portfolio companies — creating the possibility for more multi-billion-dollar implosions and scandals like the one that toppled Theranos and its charismatic founder, Elizabeth Holmes. Indeed, one of the study’s authors, Dr. John Ioannidis, the co-director of the Meta-Research Innovation Center at Stanford and director of the […]

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The FDA OK’d an app as a form of birth control

Don’t want to get pregnant? There’s a Food and Drug Administration approved app for that. The FDA has just given the go ahead for Swedish app Natural Cycles to market itself as a form of birth control in the U.S. Natural Cycles was already in use as a way to prevent pregnancy in certain European countries. However, this is the first time a so-called ‘digital contraceptive’ has been approved in America. The app works using an algorithm based on data given by women using the app such […]

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