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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
The potential for cleanroom contamination and other deficiencies led to a Form 483 for UFP Technologies, following an FDA inspection of the company’s Chicopee, Mass. facility. Read More
PerkinElmer has gained FDA marketing authorization for its EONIS assay to simultaneously detect spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns — making it the first assay authorized by the FDA for SMA screening in newborns. Read More
Sponsors of medical devices will see increased user fees under the recently reauthorized Medical Device User Fee Amendments (MDUFA) V, but they can also look forward to more rapid submissions and approvals under a new user fee funded pilot program, according to one Washington D.C.-based regulatory attorney. Read More
Despite failing to garner U.S. approval, Australian devicemaker Artrya has nabbed regulatory approvals in both the EU and UK to market its Salix CT scan analysis software for identifying arterial plague build-up that can cause coronary artery disease. Read More
WCG Imaging has been named one of this year’s top 10 medical device testing and certification companies by MedTech Outlook, a medical technology publication. Read More