CHICAGO, April 15, 2026 /PRNewswire/ — AIRS Medical today announced that SwiftMR®, an FDA 510(k)-cleared, vendor-neutral MRI image enhancement solution, has received clearance to operate in conjunction with deep learning (DL) reconstruction pipelines from original equipment manufacturers (OEM).
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 announced today that it received CE mark for its Kardia 12L electrocardiogram (ECG) system.
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.
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.
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)
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.
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.
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 new study suggests a simple letter change can reverse sex development, causing a mouse with female chromosomes (XX) to develop male genitalia.