September 22, 2023
On September 6th, 2023, the FDA released three draft guidances with the stated of goal of “…Part of Ongoing Efforts to Modernize the Premarket Notification [510(k)] Program”. I can not encourage industry and regulatory professionals enough to review…Read More
August 24, 2023
Two devices with recent De Novo Classifications were reported on recently in the Viz.ai HCM and Better Therapeutics devices that employ Artificial Intelligence (AI) and/or Machine Learning (ML). The Classification Order for both were recently published and present…Read More
August 17, 2023
It is not often the FDA offers truly transformative guidance to enable industry to constructively advance cutting edge technology in a practical way. But with the draft FDA guidance titled “Marketing Submission Recommendations for a Predetermined Change Control…Read More
August 8, 2023
Medical device makers have seen a productive summer with warm receptions at FDA for Artificial intelligence (AI) enabled devices. Over the last five weeks, a number of De Novo classifications and 510(k) clearances granted by FDA cover a…Read More
September 13, 2018
Apple made a number of high profile announcements yesterday regarding their new iPhone releases, but of particular interest to the medical device world was the Apple Watch Series 4 product announcement by the Verge on the incorporation of…Read More
January 21, 2018
Honda announced this week that they received a Medical Devices Directive (Council Directive 93/42/EEC) certification for their Honda Walking Assist Device, an assistive device for use in the training and rehabilitation of walking, which allows Honda to affix…Read More
March 8, 2016
IBM (NYSE: IBM) announced last month that Watson Health will gain the ability to analyze the cost and treatment data on more than 200 million patients with the $2.6 Billion purchase of Truven Health Analytics. This comprised the fourth…Read More
January 7, 2016
There was a time not too long ago when medical devices were launched to the world almost exclusively at preeminent medical society meetings, primarily to gain the focused attention of physicians and/or other medical professionals who may use…Read More
October 29, 2015
A flurry of recent reports in the Wall Street Journal, New York Times, Forbes and Reuters regarding Theranos states it is using an unapproved medical device, not adequately following up on customer complaints and suffers from other quality control deficiencies.…Read More
September 22, 2015
Fitbit (NYSE: FIT) announced last Wednesday that it is adding HIPAA compliance protocols related to its privacy and security for its Fitbit Wellness division. The U.S. Health Insurance Portability and Accountability Act (HIPAA) is the primary U.S. law…Read More
