Zimmer Biomet wins expanded FDA nod for shoulder systems
April 16, 2026
Zimmer Biomet (NYSE:ZBH) announced that it received FDA 510(k) clearance for a line extension to its existing Identity and Comprehensive shoulder system
Zimmer Biomet (NYSE:ZBH) announced that it received FDA 510(k) clearance for a line extension to its existing Identity and Comprehensive shoulder system
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.
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.
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.
Protaryx Medical announced that it received FDA 510(k) clearance for its proprietary Transseptal Puncture Device.
ProSomnus announced today that it received FDA 510(k) clearance for its RPMO₂ obstructive sleep apnea (OSA) therapy device.