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Light Age received a Form 483 for multiple deficiencies observed in an inspection of its Somerset, N.J., facility including the lack of a device master record and failing to launch corrective and preventive action (CAPA) procedures.
Healthcare analytics company Aetion has entered into a five-year collaboration with the FDA to use its Aetion Evidence Platform (AEP) to analyze novel oncology real-world data and answer questions about cancer prevention, clinical care, diagnostics and treatment.
The commissioner called for improved “access to high-quality data from traditional clinical trials, electronic health records, and personal devices and wearable sensors.”
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