MedTech News
.................... by Andrew Celentano
UTR Therapeutics Inc. Announces U.S. FDA Orphan Drug Designation and Rare Pediatric Disease Designation for UTRxMYCN M1-14
U.S. FDA Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) underscore UTRxMYCN M1-14’s therapeutic targeting of the “undruggable” MYCN (N-MYC) in rare, aggressive soft tissue sarcomas, addressing a significant unmet clinical need in pediatric and adult sarcomas.
VertigoDx Secures FDA 510(k) Clearance for SmartVertigo® Point-of-Care Vestibular Diagnostic System
Mobile platform combines smartphone technology, a proprietary light-occluding headset, and AI-assisted software to capture and analyze nystagmus without complex equipment.
5 Infections, Including Epstein-Barr Virus, Were Linked to 2.3 Million New Cancer Cases in 2024
Learn how H. pylori, HPV, hepatitis B and C, and the virus behind mono can lead to cancer, and how vaccines and treatment can reduce risk.
New AI tool can predict where glioblastoma is most likely to return after initial surgery
A new AI-based model can predict where glioblastoma is most likely to return after initial surgery, potentially giving doctors a chance to treat it before it becomes visible on MRI.
NUS team unveils electronic skin that lets users “see” touch instantly
New electronic skin combines sensing and visualisation in a single device, enabling high-resolution mapping of touch for healthcare and robotics applications
Insera Therapeutics, Inc. Receives U.S. FDA 510(k) Clearance for the CLEAR™ Aspiration System Featuring Cyclical Aspiration
DALLAS, Sept. 28, 2026 /PRNewswire/ — Insera Therapeutics, Inc., a medical device company focused on advancing cyclical aspiration for mechanical thrombectomy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the CLEAR™ Aspiration System.
Belly Button Odor Could One Day Help Detect Parkinson’s, Cognitive Impairment, and COVID-19
The scent of your belly button, nose, or ear may one day be used to make medical diagnosis.
Scientists find the gene that drives T-cell exhaustion, revealing new strategy to improve immune responses
Immunotherapy, which uses a patient’s immune system to treat disease, has increased survival for some adults and children with cancer. However, it has had limited success against many pediatric solid tumors, in part because T cells can become functionally impaired or “exhausted.” St. Jude Children’s Research Hospital scientists published results in Nature showing that the gene ZMYND8 is a major regulator of CD8+ T-cell exhaustion.