Medtech in a Minute: How the Mighty Have Fallen
14 Apr 2023
Elizabeth Holmes Will Do Time for Her Crime
Judge Edward Davilia denied Elizabeth Holmes' request to stay out of prison pending her appeal. Holmes will now have to begin her sentence of 11 years and three months on April 27. The former medtech CEO was found guilty on four counts of fraud in January 2022 and was sentenced in November.
Pear Falls from the PDT Tree
The pioneer of the prescription digital therapeutics (PDT) market, has filed for bankruptcy. Pear said it would continue scaled-down operations during the bankruptcy process as it seeks to execute an expedited sale process. But, the company will do so without CEO Corey McCann, who was part of yet another reduction in force. "This is certainly not the outcome I envisioned when I founded Pear in 2013," McCann wrote in a LinkedIn post.
And in case you missed our last Medtech in a Minute report...
Ex-Magellan Execs Charged with Fraud
Three former Magellan Diagnostics executives are now facing multiple criminal charges. Ex-CEO Amy Winslow, Ex-COO Hossein Maleknia, and Reba Daoust, the company's former head of quality assurance and regulatory affairs, are accused of concealing a device malfunction that allegedly produced inaccurately low lead test results for tens of thousands of children and other patients.
EPA Cracks Down on EtO, Industry Resists
The Environmental Protection Agency (EPA) is pushing for tougher standards on pollution from several toxic chemicals widely used for sterilizing medical equipment, including ethylene oxide (EtO). The problem is EtO, while known for causing certain cancers, is the only sterilization method available for many medical devices.
Abbott's Popular Diabetes Device Recalled
After Abbott initiated a medical device correction for its FreeStyle Libre continuous glucose monitoring readers, FDA issued a notice classyfing it as a class I recall. The company has received a limited number of global reports (0.0017%) from users over several years saying their reader’s lithium-ion battery swelled or infrequently overheated. In very rare cases, users reported that the battery sparked or caught fire.
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