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The approval was based on a clinical trial in which about 35 percent of the 106 enrolled ovarian cancer patients were positive for the marker, as determined by the assay. Read More
Cybersecurity relates closely to both design controls and risk management in the medical device arena. So, any efforts to address cybersecurity must be incorporated into existing design and development planning, as well as overall risk management practices. That means that companies cannot simply stick an authentication algorithm or other Band-Aid on their connected device and be in compliance with regulations. Read More
DeVilbiss Healthcare received a Form 483 from the FDA for inadequate complaint handling, design verification and lack of corrective and preventive action (CAPA) procedures, following an Aug. 1-17 inspection of its Somerset, Pa., facility. Read More
A newly updated “playbook” issued by MITRE under contract with the FDA aims to help hospitals integrate medical device cybersecurity into their emergency plans. Read More
Lantheus, which specializes in radiopharmaceutical diagnostic and therapeutic products, will pay $260 million in upfront license fees — with potential for another $1.8 billion — for worldwide rights to two of POINT Biopharma’s late-stage cancer therapeutic candidates. Read More
Roche’s Ventana FOLR1 assay has been approved by the FDA as the first companion diagnostic test to identify patients eligible for treatment with ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) also recently FDA approved. Read More