CERTIFICATIONS

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.

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.

ProSomnus announced today that it received FDA 510(k) clearance for its RPMO₂ obstructive sleep apnea (OSA) therapy device.

Used with Beckman’s immunoassay analysers, MeMed’s BV test has been demonstrated to reduce unnecessary antibiotic use.

Modular Medical (Nasdaq:MODD) announced today that it received FDA 510(k) clearance for its next-generation insulin patch pump.