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The Centers for Medicare & Medicaid Services is willing to pay for Myriad Genetics’ Prolaris prostate cancer test via a local coverage determination proposed by a South Carolina Medicare contractor. Read More
The FDA issued a final rule Wednesday placing nucleic acid-based IVDs for the detection of Mycobacterium tuberculosis complex in Class II with special controls. The rule also covers use of the tests to detect genetic mutations associated with MTB complex antibiotic resistance in respiratory specimens. Read More
International medical device regulators are trying to entice more companies to participate in a single-audit pilot program, promising they will receive no warning letters unless the issues pose an immediate threat to public health.
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Industry groups are warning the FDA that its draft guidance on risks versus benefits in 510(k) submissions could trigger new requirements for clinical trials that are inconsistent with the premarket notification process. Read More
Premarket submissions for flow cytometry devices should include a description of quality controls to ensure the device performs accurately throughout its lifecycle, the FDA says. This should include each analytical parameter reported by the device, including fluorescence intensity measures, when relevant. Read More
A federal court has barred Ethicon Endo-Surgery unit from manufacturing, promoting and selling its newest ultrasonic surgical tool, the latest turn of the screw in an ongoing patent infringement dispute between the Johnson & Johnson subsidiary and Irish devicemaker Covidien. Read More
The FDA has cited Zoll Manufacturing for failing to adequately validate its Class III medical Life Vest, noting that “approximately half of all treatments delivered to patients are inappropriate shocks,” according to a recent warning letter. Read More
Bard’s Lutonix cleared the FDA hurdle, making it the first drug-coated angioplasty balloon catheter to treat peripheral artery disease in the leg approved for use in the U.S. But it could be another year or more before the technology wins over payers. Read More
Devicemakers could come under increased scrutiny for false claims violations, thanks to a decision by the Department of Justice to routinely share qui tam complaints with both its civil and criminal divisions. The move, announced last month, will allow parallel investigations to be opened more quickly. Read More
With a comprehensive regulatory framework for devices set to take effect on Nov. 25, Japan’s Pharmaceutical and Medical Devices Agency still hasn’t published many of the implementing regulations, leaving industry to guess how best to prepare. Read More
The FDA’s latest tweak to its list of recognized standards add references on catheters and batteries, but withdraws one on blood glucose testing. Read More