MedTech News

L&C Bio Secures World’s First NMPA Approval for ‘MegaDerm Plus’ in China
SEONGNAM-SI, South Korea, Jan. 22, 2025 /PRNewswire/ — L&C Bio (CEO Hwan-Chul Lee) has achieved a significant milestone in its global market strategy by becoming the first company worldwide to secure approval from China’s National Medical Products Administration (NMPA) for its acellular dermal matrix, “MegaDerm Plus.”

Innovative bioprinting method creates heart tissues with dynamic shape changes
Researchers at University of Galway have developed a way of bioprinting tissues that change shape as a result of cell-generated forces, in the same way that it happens in biological tissues during organ development.

FDA clears Nalu peripheral nerve stim tech for whole-body MRI
Nalu Medical announced today that the FDA cleared expanded labeling of its peripheral nerve system to include whole-body MRI use.

Trump is back: Here’s what his initial actions mean for medtech
President Donald Trump has returned to office and swiftly enacted a series of executive orders that could impact the medtech industry.

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.

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.

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.

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.