MedTech News

Datar Cancer Genetics Introduces Revolutionary Tumor-Agnostic + Informed Blood Test for Residual Disease Monitoring

LONDON and MUNICH and NEW DELHI, Jan. 21, 2025 /PRNewswire/ — Datar Cancer Genetics (DCG) today announced the launch of Target-MRD, an advanced molecular residual disease (MRD) monitoring blood test for solid organ cancers. Target-MRD is a blood test based on tumor-agnostic next-generation sequencing (NGS) and customized, tumor-informed droplet digital PCR (dd-PCR) assay.

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Inflammatix Receives FDA Clearance for First-in-Class TriVerity™ Test

SUNNYVALE, Calif., Jan. 21, 2025 /PRNewswire/ — Inflammatix, a pioneering host response diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the TriVerity™ Test System (TriVerity), a first-in-class molecular test for patients with suspected acute infection or sepsis. Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid and holistic snapshot of a patient’s status.

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IntelliGenome Receives FDA Breakthrough Device Designation for CRISPR-TB Blood Test

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.

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Glooko Secures Reimbursement for Remote Monitoring of Gestational Diabetes in France

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.

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B. Braun Launches Clik-FIX® Epidural/PNB Catheter Securement Device

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.

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