FDA clears Instylla’s Tembo Embolic System
January 28, 2025
Instylla today said it has won FDA 510(k) clearance for its Tembo Embolic System.
Instylla today said it has won FDA 510(k) clearance for its Tembo Embolic System.
BALLERUP, Denmark and REDWOOD CITY, Calif., Jan. 27, 2025 /PRNewswire/ — Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, today announced the immediate commercial launch and FDA 510(k) clearance and CE Mark for Norlase® LYNX™, the world’s first and only pattern scanning laser indirect ophthalmoscope.
Imperative Care announced today that it has secured FDA 510(k) clearance for its Zoom comprehensive stroke thrombectomy system.
Stereotaxis (NYSE:STXS) said today that it has secured CE mark approval for its Magic robotically-navigated magnetic ablation catheter.
MINNEAPOLIS, Jan. 23, 2025 /PRNewswire/ — Saluda Medical, Inc., a pioneer in the development and commercialization of a novel neuromodulation platform designed to transform the lives of patients with chronic neurological conditions, today announced United States (U.S.) Food & Drug Administration (FDA) approval for its biomarker-based, automated patient programming platform in spinal cord stimulation (SCS), representing a significant advancement for SCS therapy.
Nalu Medical announced today that the FDA cleared expanded labeling of its peripheral nerve system to include whole-body MRI use.
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.
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.
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.
CergenX announced today that the FDA granted breakthrough device designation for its Wave device for neonatal brain monitoring.