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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
While Shield, Guardant’s blood-based colorectal cancer screening test, got an overall thumbs-up from an FDA advisory committee, members stressed that it’s no substitute for colonoscopy. Read More
Hologic BioZorb Markers with excessive adverse event reports and Vyaire Medical’s Twin Tube with the potential for the nozzle separating during patient use have been deemed as Class I recalls by the FDA. Read More
Drug shortages, patent tussles, and gripes about the Inflation Reduction Act (IRA) headlined the conversation at an FDA “check-up” meeting conducted by the House Energy and Commerce’s subcommittee on health. Read More