The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that has allegedly harmed patients and is now the subject of a criminal investigation.
FDA announces recall of heart pumps linked to deaths and injuries
There are about 90 sterilizing plants in the U.S. that use ethylene oxide, and for decades companies used the chemical to sterilize medical products without drawing much attention.
Congressional watchdog will launch inquiry into FDA oversight of medical device recalls
Sens. Dick Durbin and Richard Blumenthal asked the Government Accountability Office to investigate the regulatory agency, citing ProPublica and Pittsburgh Post-Gazette reports on the 2021 recall of Philips breathing machines.
Deep flaws in FDA oversight of medical devices, and patient harm exposed in lawsuits and records
Therabody’s The Workout Called Life is a 360-degree broadcast media campaign to highlight its updated packaging, merchandising and technological capabilities.
Despite readings skewed by race, pulse oximeter makers stand by their devices
Takeda announces deals worth more than $1 billion; biotech and pharma investments reached $10.5 billion in 2017; prescriptions for nerve pain on the rise
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