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Cancer care and software technology maker Varian announced that the FDA has granted an investigational device exemption (IDE) for a pivotal multi-center, international trial of its cardiac radioablation (CRA) system for patients with high-risk refractory ventricular tachycardia (VT). Read More
DePuy Synthes — a subsidiary of Johnson & Johnson — has agreed to pay $9.75 million to resolve allegations it violated the False Claims Act by paying kickbacks to a Massachusetts-based orthopedic surgeon to induce his use of DePuy products. Read More
FDA Commissioner Robert Califf laid out his priorities for “a major reformation of our national system for generating medical evidence” and wearable sensors were at the top of his list, in an article in the journal Clinical Trials. Read More
The SEIU-United Healthcare Workers West union in California has petitioned the FDA to issue corrective recalls for Fresenius 2008K2, 2008T, and 2008T BlueStar hemodialysis machines to protect patients from high ultrafiltration rates and assure accurate conductivity — concentration of dialysis fluid.
The FDA has sent Surmodics a Complete Response Letter for its SurVeil drug-coated balloon, asking the company to amend its premarket approval application (PMA) to add information on biocompatibility and labeling.
In a letter to the White House, AdvaMed defended the medical sterilization industry’s use of ethylene oxide (EtO) and asked for consideration of several points for the Environmental Protection Agency’s (EPA) proposed regulation of the sterilization process for medical devices.
The FDA has released a final rule on radiological health that revises documentation requirements, allowing more time for submitting reports for accidental radiation occurrences (AROs).
The FDA has granted a priority review for Purdue’s abbreviated new drug application for nalmefene prefilled syringes for complete or partial reversal of opioid overdose.