It has been highly anticipated that FDA was planning to issue a new proposed rule on laboratory developed tests (LDTs) with suggestions that a proposed rule could come in by the end of this week. The expectation clearly…Read More
September 29, 2023
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September 28, 2023
FDA Transition Plan in Action as Demonstrated by Akili EndeavorOTC Product
In March 2023, the FDA released a final guidance titled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency“, which at high level set out a timeline…Read More
March 8, 2016
IBM buys Truven for $2.6 Billion, now has Health-Related Data on “approximately 300 million patient lives” with Watson Health
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
October 29, 2015
Theranos and the FDA: A Cautionary Tale on the Need for Regulatory Strategy
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
