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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.
Somite Therapeutics Announces FDA Orphan Drug and Rare Pediatric Disease Designations for SMT-M01 in Duchenne Muscular Dystrophy
"Receiving both Orphan Drug and Rare Pediatric Disease Designations for SMT-M01 is a significant milestone for Somite Therapeutics and, more importantly, for patients suffering from Duchenne muscular dystrophy," said Dr. Micha Breakstone, Founder and CEO of Somite Therapeutics. "These designations underscore the critical unmet need in DMD and the potential of our AI-driven approach to develop innovative cell therapies. We are committed to advancing SMT-M01 through clinical development as rapidly as possible to make a meaningful difference for DMD patients and their families."
Withings Sleep Rx Receives FDA Clearance for the First Contactless Device to Aid in the Diagnosis of Sleep Apnea
“We’re thrilled to bring Sleep Rx to the U.S. market,” said Antoine Robiliard, VP of Withings Health Solutions. “Enabling earlier and more precise diagnosis, Sleep Rx creates a new sleep apnea diagnosis and management paradigm. We know that a one-night assessment is not sufficient. By enabling more efficient and lower-cost home-based OSA diagnosis, Sleep Rx could not only reduce the staggering $150 billion annual economic burden of undiagnosed sleep apnea but also significantly improve long-term health outcomes.”
SKG1108 Receives FDA Orphan Drug Designation for Retinitis Pigmentosa | Reports Skyline Therapeutics
SKG1108 is a recombinant adeno-associated virus (rAAV) vector with innovative design, utilizing the novel intravitreal capsid AAV.0106 to deliver single-stranded DNA encoding light-activatable proteins directly to the retina. The protein, regulated by specific genetic elements, aims to improve or restore visual function by generating new photo-sensing cells, thereby compensating for the loss of rod and cone photoreceptors in patients with late-stage RP, agnostic on the specific gene or genetic mutation responsible for the condition.
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."