The FDA released a final guidance update to the General Wellness: Policy for Low Risk Devices today (January 6, 2026) in what could only be characterized as a sudden and momentous event. It is worth noting that this…Read More
January 6, 2026
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Category: Wearables
August 17, 2023
Comments on FDA Draft Guidance Related to Predetermined Change Control Plan for Artificial Intelligence and Machine Learning (AI/ML) Enabled Device Software Functions
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
January 7, 2016
The New Launchpad for Mobile Medical Device Apps: the Consumer Electronics Show
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
August 7, 2015
IBM’s Watson to “See” Clinical Imaging Data with $1B Acquisition of Merge Healthcare
IBM (NYSE: IBM) announced yesterday that Watson will gain the ability to “see” by uniting Watson’s advanced image analytics and cloud-based cognitive capabilities with data and images obtained from Merge Healthcare (NASDAQ: MRGE). The announced merger is valued…Read More
June 19, 2015
The impact of Fitbit IPO on digital health
The dust has settled after the successful IPO of Fitbit (NYSE: FIT), who can accurately be described as the world’s largest wearables maker. Fitbit raised approximately $732 million from a $20/share pricing (valuing the company at $4.1 billion) and…Read More
