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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
Given past experience with metal-on-metal joint replacements, the introduction of new prostheses should be both gradual and backed up by new and stronger preclinical and clinical studies, a panel of scientific experts in the EU says. Read More
The FDA on Tuesday reversed itself and said it won’t require devicemakers to submit formal reports when they make safety enhancements to their products. Read More
India’s medtech industry could reach $50 billion by 2025 if comprehensive regulatory and reimbursement infrastructures are put in place, a new market research report says. Read More