Supply Chain

Medtronic recalled 348,616 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators because they might fail to deliver energy when high voltage therapy is needed, the FDA said July 18. 

Nearly 8,000 cardiac panel blood tests have been recalled after 41 reports of inaccurate test results that pose the risk of missing a heart attack diagnosis, the FDA said July 17. 

Researchers from NYU Langone Health and University of New York, both based in New York City, found discrepancies in the marketing of artificial intelligence and machine learning-enabled medical devices compared with FDA approval summaries.

About 1,060 ventilator products between two companies are recalled because of the risk of serious injury or death, the FDA said July 13. 

Detroit-based Henry Ford Health tapped HPC International, a purchased services supplier for healthcare, on July 11 to manage its expenses process. 

Health systems that are not prepared for "supply shocks" can face reputational and financial losses and quality care issues, according to a July 11 article from McKinsey. 

More than 60 burn injuries have been reported in connection to electrosurgical pads made by Megadyne, a medical device company owned by Johnson & Johnson's Ethicon division, the FDA said July 11. No products are pulled from the market, a company…

Four years after the FDA said there could be a higher risk of death with paclitaxel-coated devices used for peripheral arterial disease, the agency concluded July 11 the evidence does not support this possibility. 

Guilford, Maine-based Puritan Medical Products, a supplier of medical swabs, issued a WARN notice June 28 regarding the closure of its Portland, Tenn., manufacturing plant. The company has also made cuts in its home state, according to documents.

Lumos Diagnostics has received FDA clearance to market a rapid diagnostic test meant to support clinicians in determining when to prescribe antibiotics for acute respiratory infections.