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Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
FDA Approves Illumina Cancer Biomarker Test with 2 Companion Diagnostics to Rapidly Match Patients to Targeted Therapies
"FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community," said Everett Cunningham, chief commercial officer of Illumina. "We are committed to partnering with industry leaders like Bayer and Lilly to advance cancer diagnostics and help broaden access to precision oncology for more patients."
Qure.ai Launches FDA-cleared AI Solution for Advanced Lung Nodule Quantification on CT Scans at AABIP 2024
Qure.ai reports the new AI solution is now available to support radiologists and pulmonologists in analyzing lung nodules on non-contrast chest CT scans and tracking volumetric growth as part of progression monitoring.
GrayMatters Health Expands Veteran and Civilian Access to FDA-Cleared Prism for PTSD™ Treatment
Home Base, the first and largest private sector brain health clinic in America treating Veterans, Service Members, their Families and Families of the Fallen, is adding Prism as a potential supplementary treatment option to enhance their existing PTSD programs at the National Center of Excellence in Charlestown, Massachusetts reports GreyMatters Health.
Guard Medical Announces FDA 510(k) Clearance for Additional Large Sizes of Its Novel NPseal® NPWT Surgical Dressing
“We’re excited to expand our portfolio with the NPseal 20 and NPseal 25. FDA clearance for the additional large sizes allows NPseal to become the dressing of choice for the treatment of closed surgical incisions in orthopedic, cesarean, and cardiothoracic procedures,” stated Machiel van der Leest, CEO of Guard Medical. “We believe that NPseal uniquely fits in the ever-increasing outpatient trend requiring higher patient mobility and self-care.”
Pneuma Systems Infusion Technology Accepted by FDA’s Highly Selective Safer Technologies Program (STeP)
"This is a tremendous milestone," says Pneuma Systems Founder and CEO Jeffrey Carlisle. "Not just for Pneuma, but for the infusion pump industry and, most importantly, for patients and nurses everywhere."
Labcorp Receives FDA De Novo Marketing Authorization for PGDx elio plasma focus Dx
"The launch of PGDx elio plasma focus Dx represents a landmark expansion of Labcorp's suite of precision oncology solutions," said Shakti Ramkissoon, M.D., Ph.D., MBA, vice president, medical lead for oncology at Labcorp. "This latest liquid biopsy test offers laboratories and oncologists a convenient, cost-effective and highly targeted tumor-profiling solution that spans a wide range of solid-tumor types – particularly when tumor tissue is limited or unavailable. When paired with PGDx elio tissue complete, Labcorp now offers laboratories access to tissue and liquid genomic-profiling assays that operate on the same instrument, enabling seamless integration of these precision oncology products into routine laboratory workflows. The ability to test tissue or liquid will provide critical data and insights needed to inform more personalized treatments and care plans for patients."
FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma
"Potentially life-threatening cancers such as synovial sarcoma continue to have a devastating impact on individuals, especially those for whom standard treatments have limited efficacy due to tumor growth and progression," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER). "The approval of this state-of-the-art immunotherapy technology provides a critical new option for a patient population in need and demonstrates the FDA's dedication to the advancement of beneficial cancer treatments."
Stryker’s Spine Guidance 5 Software featuring Copilot receives 510(k) clearance from FDA
Q Guidance System with Spine Guidance 5 Software featuring Copilot is a first-to-market technology, pioneering new planning and surgical capabilities.
Asensus Surgical Receives FDA 510(k) Clearance for Senhance Surgical System in Urology
“This FDA clearance marks another milestone for Asensus Surgical and represents an additional indication expansion in the U.S. market,” said Anthony Fernando, Asensus Surgical President and CEO. “The Senhance System's precision and advanced digital capabilities make it uniquely suited for urological procedures, offering surgeons the benefit of digital tools and smaller instrumentation. We are excited to bring this technology to urologists and their patients across the United States.”
