MedTech News
.................... by Andrew Celentano
Blood test can predict Alzheimer’s disease progression years before symptoms or brain scan changes
A study by investigators at Mass General Brigham has found that a blood test of plasma phosphorylated tau 217 (pTau217), an Alzheimer’s disease biomarker, can predict the progression of amyloid PET scan changes and cognitive decline in cognitively healthy older adults.
CRISPR takes a bold leap toward silencing Down syndrome’s extra chromosome
Scientists have taken an important step toward a gene therapy that could one day turn off the extra genetic material that causes Down syndrome (DS)
TOBY Receives FDA Breakthrough Device Designation for Its Urine-Based Multi-Cancer Early Detection (MCED) Test
AUSTIN, Texas, April 14, 2026 /PRNewswire/ — TOBY, Inc., a biotechnology company developing non-invasive cancer screening technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to TOBY’s urine-based Multi-Cancer Early Detection (MCED) test. The designation recognizes the test’s potential to enable earlier detection of multiple cancers through a simple, non-invasive urine sample and address a major unmet need in cancer screening.
Scopio Labs Secures EU IVDR Certification for the Industry-Only Full-Field Digital Bone Marrow Application
PARSIPPANY, N.J., April 14, 2026 /PRNewswire/ — Scopio Labs, the leader in Full-Field digital cell morphology, today announced it has achieved IVDR certification for its Full-Field Bone Marrow Aspirate (FF-BMA) Application.
Reach Surgical Receives CE Mark Approval for iREACH IRIS, First Powered Reusable Stapler with Real-Time Firing Curve™ and 90° Articulation
SINGAPORE, April 15, 2026 /PRNewswire/ — Reach Surgical, the surgical solutions division of Genesis MedTech, has received CE Mark approval for iREACH IRIS, a next-generation powered stapling platform designed to deliver Real-Time Firing CurveTM and up to 90° articulation during surgery.
A Single DNA Letter Change Can Trigger Female Mice to Develop Testes
A new study suggests a simple letter change can reverse sex development, causing a mouse with female chromosomes (XX) to develop male genitalia.
Travere’s Filspari overcomes Phase 3 fail to become first drug for rare kidney disease
The FDA has greenlit Travere Therapeutics’ Filspari as the only available treatment for focal segmental glomerulosclerosis despite the drug’s loss to Sanofi’s Avapro in a Phase 3 study.
New drug doubles one-year survival in pancreatic cancer trial
Phase 2 randomized trial shows 38% reduction in risk of death with the drug when combined with chemotherapy