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OptumHealth Care Solutions has recalled its Nimbus II Plus infusion pumps — a recall now deemed Class I by the FDA — because of the potential for the device to fail from a variety of issues. Read More
This week, the FDA issued a final rules related to the administrative destruction of medical devices that are thought to be counterfeit and announcing the termination of the Science Advisory Board to the National Center for Toxicological Research. Draft guidance was published on the platform technology designation program for drug development. Read More
The FDA has finalized a rule allowing it to destroy illegal medical devices valued under $2,500 that have been refused admission into the US as a deterrence against sellers re-shipping items previously refused admission. Read More
A clinical laboratory trade association and one of its member companies have filed suit against the FDA, asking the agency to overturn its final rule to regulate lab-developed tests (LDT) as medical devices claiming that the FDA doesn’t have the authority to scrutinize LDTs. Read More
Spinal devicemaker Innovasis and its two senior executives, Brent and Garth Felix, have agreed to settle an anti-kickback whistleblower suit for $12 million for allegedly paying kickbacks to physicians who used the company’s products. Read More
Philips Respironics has recalled several of its BiPap machines after 888 complaints of a potential malfunction of the device’s inoperative alarm which can cause the ventilator to shut down. Read More
This edition of Quick Notes looks at the FDA clearances for heart monitoring and lung disease diagnostic algorithms, an artificial pancreas app and a bipolar radiofrequency hysteroscopy system. Read More