MedTech News
.................... by Andrew Celentano
Waters Announces CE Mark for Next-Generation Fully Automated BD BACTEC FXI Culture System for Bloodstream Infection Diagnosis
MILFORD, Mass., April 15, 2026 /PRNewswire/ — Waters Corporation (NYSE: WAT) today announced that the BD BACTEC™ FXI Culture System has received CE marking under the European Union’s In Vitro Diagnostic Regulation (IVDR), enabling commercialization in Europe and representing a key milestone in the Company’s clinical microbiology portfolio expansion. The BD BACTEC FXI System is a next-generation, fully automated blood culture system designed to improve the speed, consistency, and accuracy of bloodstream infection diagnostics in modern microbiology laboratories.
AliveCor wins CE mark for 12-lead ECG
AliveCor announced today that it received CE mark for its Kardia 12L electrocardiogram (ECG) system.
A less invasive heart valve fix shows strong early results for older high-risk patients
A national study led by investigators from Cedars-Sinai Health Sciences University found that transcatheter tricuspid valve replacement, or TTVR, delivered strong early results in real-world practice.
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.