Biomerics Announces Expansion in Costa Rica With New Plant in Cartago
Biomerics inaugurated its second plant in Costa Rica. […]
GPX Embolic Device Success in Challenging Tumor Case
Fluidx Medical’s Novel Embolic Device Demonstrates Repeated Success in Treating Complex Tumors […]
Foldax Appoints Scott Huennekens to Board of Directors
Foldax Appoints Scott Huennekens to Board of Directors […]
PolarityTE Announces U.S. FDA Approval of IND for Pivotal Phase 3 Study of SkinTE® to Support Chronic Cutaneous Ulcer Indication
PolarityTE, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application for the evaluation of SkinTE for the treatment of chronic cutaneous ulcers. […]
Co-Diagnostics, Inc. JV CoSara Receives Clearance from Indian Regulators for High-Risk HPV Multiplex Test
Co-Diagnostics, Inc. announced that CoSara Diagnostics Pvt Ltd has received clearance by the Central Drugs Standard Control Organization (“CDSCO”) in India to manufacture and sell its SARAGENE™ Human Papillomavirus High-Risk (HPV-HR) Real-Time PCR test as an in vitro diagnostic (“IVD”) […]
New Peripheral Vascular Microcatheters Save Procedure Time and Advance Treatment Capabilities
New Peripheral Vascular Microcatheters Save Procedure Time and Advance Treatment Capabilities […]
Positive Study Results Published for KidneyIntelXTM in Monitoring Patient Response to New Drug Therapy
Positive Study Results Published for KidneyIntelXTM in Monitoring Patient Response to New Drug Therapy […]
CenExel Clinical Research Acquires Rocky Mountain Movement Disorders Center
Premier Neurology Facility in Colorado Joins the CenExel Centers of Excellence […]
CenExel Clinical Research Acquires California Neuroscience Research
CenExel Clinical Research, Inc. announced the acquisition of California Neuroscience Research. […]
Nexus Spine Appoints David Ivanko as Vice President of Quality Engineering and Manufacturing and Andrew Shepherd as Vice President of Marketing
Nexus Spine announced key appointments to its leadership team that includes David Ivanko as Vice President of Quality Engineering and Manufacturing and Andrew Shepherd as Vice President of Marketing. […]
Singing River Health System and Renalytix Join Forces to Improve Kidney Health on the Mississippi Gulf Coast
Seventh KidneyIntelX implementation partnership for Renalytix focused on underserved populations with high disease burden […]
Transition Plan for Medical Devices Issued FDA EUAs
To help fight the pandemic, the FDA has been issuing EUAs and exercising enforcement discretion for medical devices needed to diagnose, treat, or prevent COVID-19. Last month, the agency issued two draft guidances related to transition plans to regular compliance for COVID-19 related medical devices that fall under EUAs or Agency Enforcement Policies that have […]