HOUSTON, Jan. 21, 2025 /PRNewswire/ — IntelliGenome, an innovative molecular diagnostic solutions provider, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its CRISPR-Tuberculosis (TB) Blood Test. This test is the first qualitative real-time polymerase chain reaction (PCR) assay to combine CRISPR technology, designed to detect Mycobacterium tuberculosis (Mtb) cell-free DNA in human serum and EDTA plasma.

PALO ALTO, Calif., Jan. 21, 2025 /PRNewswire/ — Glooko, Inc., a global integrated digital health company connecting patients, providers, biopharma, and medical device partners, today announced that its Glooko XT solution has been approved for reimbursement by the Haute Autorité de Santé (HAS) and the Commission Nationale d’Évaluation des Dispositifs Médicaux et des Technologies de Santé (CNEDiMTS) in France.

SARATOGA, Calif., Jan. 21, 2025 /PRNewswire/ — CapsoVision, Inc., a leader in innovative endoscopic capsule technology, today announced that its award-winning product, the CapsoCam Plus® capsule endoscopy system, has received U.S. Food & Drug Administration (FDA) clearance for remote ingestion.

BETHLEHEM, Pa., Jan. 21, 2025 /PRNewswire/ — B. Braun Medical Inc. (B. Braun), a leader in smart infusion therapy and pain management, announced today the launch of its new Clik-FIX® Epidural/Peripheral Nerve Block (PNB) Catheter Securement Device, the latest addition to the Clik-FIX Family of Catheter Securement Devices.

A research team led by Dr. Youngdo Jeong of the Center for Advanced Biomolecular Recognition at the Korea Institute of Science and Technology (KIST), in collaboration with Professor Seok-Ho Kang’s team from the Department of Urology, Korea University College of Medicine, has developed a urine-based diagnostic kit for bladder cancer that can be conveniently used at home

A collaborative team of scientists at several research centers in the United States has found that a compound known as genipin, derived from the gardenia plant called Cape jasmine, can prompt nerve regeneration.

CergenX announced today that the FDA granted breakthrough device designation for its Wave device for neonatal brain monitoring.

MedRhythms announced that it received a final pricing determination from CMS for its InTandem rehabilitation system.