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Diagnostics & Healthcare News

FDA Grants Breakthrough Device Designation to DNAe’s Sequencing Diagnostic 

DNAe, the next generation sequencing company developing novel diagnostics for use at the point-of-need, today announced that the US Food and Drug Administration (FDA) has granted it a “Breakthrough Device” designation for its pioneering platform and first assay. DNAe has...

April 9, 2020

Diagnostics & Healthcare News

SpiderTech Helping Healthcare Workers Experiencing Irritation, Sores From PPE With Face Protection

In the midst of the COVID-19 pandemic, healthcare workers across the world have been active on social media displaying the painful results of wearing medical personal protective equipment (PPE) for long hours on the job. Face masks, surgical and N95...

April 9, 2020

Diagnostics & Healthcare News

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...

April 8, 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

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

Diagnostics & Healthcare News

EchoNous, Inc. Announces CE Mark Approval for Its Healthcare AI KOSMOS Platform

EchoNous is very pleased to announce that its KOSMOS platform has been approved for CE Markets thanks to the unbending effort of its engineering, operations and regulatory teams. The company’s engineering team has developed a medical tool that, according to physician...

March 24, 2020