Latest from Elizabeth Orr
The medtech giant violated USA and California antitrust law in its sales practices for devices used to cut and seal blood vessels during surgery, a jury found. Rival firm Applied Medical brought the case.
Cerenovus is recalling multiple products from its Cerepak Uniform, Cerepak Heliform and Cerepak Freeform product lines due to a higher-than-expected failure to detach rate. While customers were sent a safety alert in October, the US FDA announced the recall on Feb. 5.
The US FDA has warned that Magellan Diagnostics blood lead tests may provide inaccurately high results, particularly with tubes from ASP Global. Magellan’s tests had previously been recalled over inaccurate low results. The FDA also issued warning letters to both firms.
The US FDA device center’s new annual report found notable successes in 2025 that included continuing to meet user fee goals as well as making progress on patient safety, innovation, and regulatory science.
Molecular diagnostics firm SAGA Diagnostics has introduced a colorectal cancer test that can detect even very low levels of cancer biomarkers. The test helps clinicians guide post-surgical treatment decisions.
The electrostimulation pain treatment firm reportedly shipped excessive supplies to patients for eight years, driving up revenues as well as stock prices.
