Court rules that FDA cannot rescind 510(k)s without notice and comment procedures

The FDA’s powers to reclassify devices were restricted by a federal appeals court ruling that said the agency does not have the inherent authority to reclassify devices.  Rather, the FDA must follow Congress’s procedural requirements when reclassifying devices, including notice and comment procedures.

FDA Flags False Claims on Pinterest

In First, FDA Sends Warning Letters to Companies Citing Use of Pinterest:  The US Food and Drug Administration’s (FDA) long history of Warning Letters marked a new milestone today after regulators chided three companies, including one which marketed its product on a medium never before cited by FDA:  Pinterest.

Researchers develop the first blood test to diagnose adult depression

Primary care doctors may be able to run a blood panel to diagnose depression.  Researchers at Northwestern University’s Feinberg School of Medicine have identified 9 RNA blood markers that can be used as part of a panel to diagnose the mental disorder.  They said it is the first blood test to diagnose adult depression.  They published the results of their study in the Sept. 16 issue of the Nature journalTranslational Psychiatry.

Which body parts warrant the biggest biotech venture investments?

Dow Jones writer Brian Gormley set out to find out the answer to that question, reviewing the venture data for biotech and med tech in Dow Jones’ VentureSource database.  He concluded that eye diseases warranted the biggest single wager on any particular organ, with a total of $849 million in venture bets on ophthalmology startups in the field.  And $442.7 million more came in the first half of this year, indicating that there’s been no letup in the action.

iPhone 6 and Apple Watch demonstrate healthcare ambitions

Apple unveiled the iPhone 6 and its Apple Watch in September 2014, and as expected, both have major healthcare implications.  CEO Tim Cook described the innovations in a much-anticipated announcement about the company’s new products as it attempts to show that it can continue to innovate in the post-Steve Jobs era.