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.
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.
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.
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.
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.
The China Food and Drug Administration (CFDA; previously SFDA) will launch an expedited registration process on March 1, 2014 to increase availability of innovative and cutting-edge medical devices in the country.
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.
The FDA’s Center for Devices & Radiological Health aims to improve its clinical trial process, better balance pre- and post-market data gathering and “provide excellent customer service” in 2014.
DA Mulls Faster OK for High-Ned Devices; The FDA wants to create an expedited approval pathway for high-risk medical devices for unmet needs, saying current tools at its fingertips are ineffective for speedier approvals.
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.