Apple announces open-source data-collection platform for mobile medical apps

In typical Apple style, CEO Tim Cook announced the debut of its open-source platform for creating mobile medical apps while standing in front of a black background at a glitzy event in San Francisco in March.  But the news contained substance too, at least from a med tech perspective.

Apple’s ResearchKit is off to a rollicking start

People are hungry to participate in the first 5 iPhone-based studies enabled by Apple’s ResearchKit.  More than 19,000 participants have signed on within the first 24 hours of the mobile medical app platform’s debut.

Watchdog groups decry FDA’s move to let reps hand out journal articles

Little did the FDA know that allowing drug makers to hand out medical-journal articles to doctors would be so controversial.  After talking about the idea for years, since 2007 at least, the Agency rolled out some guidelines last June that would govern the practice.  And now, the consumer watchdogs at Public Citizen, along with a bevy of patient groups, are in full protest mode.

FDA approves closure system to permanently treat varicose veins

The U.S. Food and Drug Administration approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent in February 2015.  This device is first to use adhesive to cut off blood supply.

FDA Creates Unregulated Device Category for General Wellness Products

The FDA has created a new category of devices – general wellness products – that the agency will exempt from regulation. The concept is a boon to makers of apps and other products that help manage weight loss, fitness, stress, sleep, and other aspects of good health.

Analysis of 24,000+ FDA 510(k) records reveals trends

Medical Device Manufacturers often wonder how long it will take for their medical device 510(k) submission to clear.  The short answer is: it depends.  But that answer doesn’t really satisfy most people.  A few years ago the Emergo Group (EG) decided to take a more scientific approach to the issue and started examining FDA data to see how long it really takes a 510(k) to be cleared by the FDA.  This year, EG updated their analysis of all medical devices cleared via the 510(k) process between 2006 and the end of 2013.