Friday, 16 Nov 2018
Category: fda

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 market a new hearing aid device. Dubbed the Bose Hearing Aid, it’s designed to let people with audio impairments fit, program and control the […]

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 headquarters, TechCrunch has confirmed. The unannounced inspection of the startup’s headquarters on Friday was part of the FDA’s efforts to seek documentation related to Juul’s sales and […]

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 after the startup agreed to clarify the risk of the product failing. But, on the self-reported data front, the agency said it was satisfied the number of unwanted pregnancies is in line […]

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 continuing to tank. The company sells a competing wearable health and fitness device.  Apple’s newest watch, starting at $399, can now perform an […]

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 increasing scrutiny. Here’s the statement from Juul Labs CEO Kevin Burns: We fully support FDA’s efforts to curb underage use […]

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 contains CBD, a cannabis chemical compound skyrocketing in popularity and driving what is estimated to have doubled into a $200 million market in 2018. CBD is […]