Posts by cstephenson@legacymedsearch.com
Celularity Announces FDA Clearance of IND Application for CYNK-001 in Coronavirus, First in Cellular Therapy
Celularity Inc., a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for the use of its proprietary CYNK-001 in adults with COVID-19. With this, Celularity will commence a Phase I/II clinical study including up to 86…
Read MoreTablo Hemodialysis System Receives FDA Clearance for Home Dialysis
Outset Medical, a leading med tech innovator delivering first-of-its-kind technology into the growing global dialysis market, today announced the Food and Drug Administration (FDA) cleared the Tablo Hemodialysis System for patient use in the home. The new home clearance expands Tablo’s existing labeled indication for use in acute and chronic care facilities, which for the…
Read MoreCrossBay Medical Receives FDA Clearance for CrossGlide Endometrial Tissue Sampler
CrossBay Medical, Inc., a health technology company focused on improving the delivery of women’s healthcare, announced it has received clearance from the Food and Drug Administration (FDA) to market its CrossGlide™ ETS Endometrial Tissue Sampler. The CrossGlide ETS, the third product to utilize the frictionless CrossGlide technology platform, enables medical providers to perform an office-based…
Read MoreNuvo Group Receives FDA Clearance for its Innovative INVU Remote Pregnancy Monitoring System
Nuvo Group, a private company with a bold ambition to reinvent pregnancy care for the 21st century, today announced that it has received clearance from the U.S. Food & Drug Administration (“FDA”) to market INVU™, a prescription-initiated, protocol-driven remote monitoring platform that offers measurements of fetal and maternal heart rate via a wireless, self-administered INVU…
Read MoreFDA Clears Siemens Healthineers RAPIDPoint 500e Blood Gas Analyzer Used for Critically Ill Patients in Acute Care Settings
Siemens Healthineers announced today that its latest critical care testing solution, the RAPIDPoint® 500e Blood Gas Analyzer, has received clearance from the U.S. Food and Drug Administration. The analyzer generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, which are used to diagnose and monitor critically ill patients in the intensive care unit, operating…
Read MoreBattelle Announces Rapid Manufacturing of a System to Decontaminate N95 Respirator Masks
Battelle announced today that it has begun rapid manufacturing of a system to decontaminate N95 respirator masks and other medical protective equipment. Each Battelle CCDS Critical Care Decontamination System™ is capable of decontaminating up to 80,000 masks per day at full capacity. Because it is scalable, the system is capable of processing even more pieces…
Read MoreNorthwell Implements New On-site Laboratory Treatment Technology for COVID-19 Infected Medical Waste
To minimize the risk of spreading COVID-19, Northwell Health has become the first US health system to implement a new technology that breaks down medical waste from laboratory testing in a safe, environmentally friendly way. Developed by Irish-based Technopath Clinical Diagnostics, the Envetec 200 system simultaneously shreds and disinfects infectious waste using a patented destruction and disinfection…
Read MoreCardioQuip MCH-1000 Earns CE Mark Approval
CardioQuipTM, LLC, a medical device manufacturer focused on development and commercialization of patient temperature control and cardiovascular perfusion technology announced today it has received CE Mark approval for the MCH-1000TM Modular Cooler-Heater SeriesTM. The MCH-1000 Series of cooler-heaters is now available to European hospital systems fighting the COVID-19 pandemic. A cooler-heater device is used to regulate patient temperature…
Read MoreVERO Biotech Announces First Patient With COVID-19 Infection Complicating Pulmonary Hypertension Treated with GENOSYL DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide
VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering, and improving the health economics of care, today announced that the first patient with COVID-19 infection complicating pulmonary hypertension has been treated with its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS at home. The patient was treated under an emergency IND…
Read MoreOrthofix Completes Acquisition of FITBONE Limb Lengthening System
Orthofix Medical Inc., a global medical device company focused on musculoskeletal healing products, today announced it has completed the acquisition of assets associated with the FITBONE® intramedullary lengthening system for limb lengthening of the femur and tibia bones. The transaction also includes other potential applications of the technology which are in development, including the FITSPINE® system for…
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