I learned a long time ago to keep tabs on FDA import alerts, which names firms that have been deemed by FDA to be violative of import requirements for a whole host of reasons. Once on the list,…Read More
August 10, 2026
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Category: General Wellness Products
May 22, 2026
The Hunt for the Next FDA Commissioner
It is last weeks news that FDA’s leadership turnover has been the highest in memory, possibly ever. What should concern everyone is the response of industry to this degree of uncertainty at FDA. Drug company Regenxbio last week…Read More
February 12, 2026
FDA holds virtual Town Hall meeting on recent General Wellness guidance update
The FDA held a virtual town hall today (February 11th, 2026) on the General Wellness guidance update which published on January 6th, 2026. This was a highly anticipated event to address questions on the guidance, which was reported…Read More
January 7, 2026
FDA releases update to Clinical Decision Support Software guidance that expands non–regulated opportunities for AI industry
The FDA released an update to the Clinical Decision Support Software (CDS software) guidance yesterday (January 6, 2026) in what was a surprise move to virtually all in the FDA regulatory space. To put some historical context on…Read More
January 6, 2026
FDA releases update to General Wellness guidance that creates new opportunities for industry to operate without FDA regulation
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
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
