FDA Clears OrthoPediatrics’ Scoliosis System October 22, 2018 OrthoPediatrics expects to launch the system in the fourth quarter of 2018. Read More
Dexcom Wins CMS Coverage for Continuous Glucose Monitor October 19, 2018 The company expects to start shipping the system to Medicare customers in early 2019. Read More
Matrix Surgical’s OmniPore Implants Cleared for Marketing October 19, 2018 The company expects to launch additional variants in early 2019. Read More
Co-Diagnostics Gains CE Mark for Zika Screening Test October 18, 2018 Studies have linked Zika with microcephaly, a neurological disease that affects the brain development of fetuses. Read More
FDA Clears Viseon’s Voyant System October 18, 2018 The device allows the surgeon to change the depth of focus and view the surgical site on HD flat-panel display monitors. Read More
Centric Medical’s External Fixation System Cleared by FDA October 18, 2018 The fixation system can be used for Charcot reconstruction procedures and tumors. Read More
Tyto Care’s Live Video Telehealth System Receives CE Mark October 17, 2018 Tyto Care released the product in the U.S. last year following FDA clearance. Read More
CIVCO Radiotherapy’s Immobilization System Cleared in U.S. and EU October 16, 2018 The device includes a carbon fiber head support, dedicated thermoplastic mask and a customizable cushion. Read More
South Korea Health Regulator Clears Non-Small Cell Lung Cancer Diagnostic October 15, 2018 The assay analyzes tumor messenger RNA from tissue or body fluids to identify 14 ROS1 gene fusions. Read More
Tandem’s Insulin Pump Receives Health Canada Licensing October 15, 2018 The device holds up to 300 units of insulin. Read More
Health Canada Gives Green Light to Medtronic’s Insulin Pump October 15, 2018 The company expects to launch the insulin pump in Canada this fall. Read More
FDA Shoots Down Clear TearLab Dry-Eye Test for 510(k) Clearance October 12, 2018 The agency said that the dry-eye test’s application did not adequately demonstrate substantial equivalence. Read More