medical device guru

Surgery and Surgical Robotics

Allurion Technologies Announces Submission of US Premarket Approval Application for its Flagship Elipse Gastric Balloon

Allurion Technologies, an established leader in the development of innovative, proven, and trusted weight loss experiences, today announced the Premarket Approval (PMA) submission of its flagship Elipse gastric balloon. The company had previously announced the successful completion of its landmark FDA...

April 7, 2020

Diagnostics & Healthcare News

COVID-19 Antibody Test Released by Ortho Clinical Diagnostics

Aligned with its mission to improve and save lives with diagnostics, Ortho Clinical Diagnostics today announced it is launching to market its SARS-CoV-2 (COVID-19/coronavirus) antibody test—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. Testing kits are expected to be available...

April 6, 2020

Diagnostics & Healthcare News

Spectrum Solutions Saliva Collection Device Answers Critical Testing Hurdles, Enabling Large-Scale COVID-19 Testing While Protecting Health Professionals From Exposure

Spectrum DNA™, a division of Spectrum Solutions, LLC, in Salt Lake City, Utah, today announced that using the Spectrum DNA SDNA-1000 Whole Saliva Collection Device, researchers from RUCDR Infinite Biologics at Rutgers University have successfully validated saliva as being a...

April 6, 2020

Biologics, Wound Care, Infection Prevention

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...

April 2, 2020

Diagnostics & Healthcare News

Tablo 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...

April 2, 2020

Diagnostics & Healthcare News

CrossBay 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...

April 2, 2020

Diagnostics & Healthcare News

Nuvo 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...

April 1, 2020

Cardiovascular / Cardiology

FDA 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...

March 31, 2020

Biologics, Wound Care, Infection Prevention

Battelle 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...

March 30, 2020