Archive for April 2020
Stryker Releases Emergency Relief Bed, a Limited-Release Medical Bed to Support Critical Needs During Pandemic
Stryker, one of the world’s leading medical technology companies, announced today it has developed a low-cost, limited-release emergency response bed to quickly aid healthcare providers with efficient care during the COVID-19 pandemic. “People are at the heart of what we do, and COVID-19 hasn’t changed that. It has amplified our mission of making healthcare better.…
Read MorePrecision Spine Announces the Worldwide Launch of the Reform Ti Pedicle Screw System Providing Surgeons with Increased Flexibility, Versatility, and Visibility
Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has launched world wide the Reform® Ti Titanium Pedicle Screw System, which provides surgeons with the increased flexibility, versatility, and visibility that is required during today’s challenging degenerative and trauma spine procedures. The Reform Ti System features a titanium tulip and a triple lead thread to…
Read MoreAllurion 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 pivotal study and the hiring of key personnel who will be leading the US market launch. These milestones…
Read MoreCOVID-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 in a few weeks. Ortho followed the guidelines established by the U.S. Food and Drug Administration’s…
Read MoreSpectrum 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 viable biosample source for COVID-19 detection when compared to nasopharyngeal or oropharyngeal swabs. The resourceful…
Read MoreCelularity 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 More