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- Andrew Celentano

Cala Announces FDA Clearance of its Next Generation TAPS Therapy Wearable Device for Essential Tremor and Parkinson’s Disease

SAN MATEO, Calif. and CHICAGO, April 15, 2026 /PRNewswire/ — Cala®, the bioelectronic medicine leader, today announced U.S. Food and Drug Administration (FDA) clearance of the Cala kIQ® Plus system, the next-generation of its wearable neurostimulation device for action hand tremor in essential tremor (ET) and Parkinson’s disease (PD). Cala kIQ Plus is the latest advancement in TAPS® technology – introducing new therapy modes and adaptive calibration designed to optimize tremor relief and personalize treatment providing patients with an intuitive experience whenever tremor control is needed.

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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.

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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.

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