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April 7, 2023
2 Min Read
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.
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.
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.
And in case you missed our last Medtech in a Minute report...
Olympus Medical Systems is once again receiving ire from FDA as the agency issued another warning letter to the manufacturer after inspecting an additional Olympus facility in Tokyo, Japan. The letter notes a number of violations, but what stood out the most is that the company has received about 160 complaints about a distal end cover on one of its scopes dropping out, yet failed to consider that trend to be a quality data input to initiate a corrective and preventive action.
On the heels of supply chain issues, sterile packing problems, and CE mark suspensions, Getinge has to recall two models of intra-aortic balloon pumps (IABPs). FDA said the company is recalling the Cardiosave Hybrid IABPs and Cardiosave Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown. This shutdown will occur without warnings or alarms to alert the user, the agency noted.
Nvidia and Cosmo Pharmaceuticals to develop a series of AI-based tools to help treat patients. The first product on the list is a colonoscopy tool that uses AI. The technology will integrate Nvidia’s healthcare and edge technologies with Medtronic’s GI Genius intelligent endoscopy model.
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