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Evaluations for the EU: The Impact on Testing & Lab Services
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Evaluations for the EU: The Impact on Testing & Lab Services
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Breaking News
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Supply Chain
Device Sectors
Nurse-Led Company Deploys Computer Vision A.I. to Protect Healthcare Workers
The device leverages computer vision to automate enhanced contact tracing.
PR Newswire
04.30.20
Intense Engineering Releases High-Speed COVID-19 Sample Prep System
The product accelerates testing by processing 1,000 test sample tubes per hour.
PR Newswire
04.30.20
FDA Grants Medtronic Marketing Authorization for Pediatric Continuous Dialysis Therapy
The Carpediem System is approved for use in pediatric patients with certain kidney conditions.
PRNewswire
04.29.20
MedTech Seeks Additional Tariff Relief in COVID-19 Battle
Ventilator parts and diagnostic equipment among more than 80 devices suggested for exclusion.
AdvaMed
04.29.20
Diagnostics
Medical Diagnostic Laboratories Launches Serological Test for COVID-19 Antibodies
The advantage of serological diagnostic assays over direct detection of the virus by RT-PCR is their ability to detect past infections.
PR Newswire
04.29.20
3D/Additive Manufacturing
3D Printing Industry Answered Call to Arms Against COVID-19
The AM community has responded with a pledge to support the production of vital medical equipment for hospitals tackling the pandemic.
GlobalData
04.29.20
Diagnostics
Hardy Diagnostics Gains EUA for COVID-19 Rapid Antibody Test Kit
Partnership with Autobio Diagnostics Co. enables firm to become exclusive U.S. supplier of assay that detects IgM and IgG antibodies.
Newswire.com
04.29.20
3M Exceeds Expectations Despite COVID-19 Impact
The company accounts for 60 percent of the sales of the N95 respirator.
GlobalData
04.29.20
Former Zimmer Biomet Interim CEO Joins Pulmonix Board of Directors
New board member also worked for Boston Scientific Corp. and C.R. Bard.
Business Wire
04.29.20
FDA Approves Continuation of Senseonics Study on Glucose Monitoring System
Thirty-five participants will now be monitored for a total of 365 days.
Business Wire
04.29.20
Stretchable, Wearable Coils May Make MRI, Other Tests Easier on Patients
Team from Purdue University has developed radio-frequency coils that are formable and stretchable.
Purdue University
04.29.20
Health Canada Authorizes Gas Exchange Monitor for COVID-19 Use
Device is used to rapidly assess a patient's respiratory status, non-invasively.
PR Newswire
04.29.20
Diagnostics
Quest Diagnostics Launches Consumer-Initiated COVID-19 Antibody Test
Individuals can purchase the test online through QuestDirect.
PRNewswire
04.28.20
Diagnostics
LabCorp COVID-19 Antibody Tests Become Available Nationwide
No upfront out-of-pocket costs will be included.
LabCorp
04.28.20
Neurological
Light-Based Deep Brain Stimulation Relieves Parkinson's Symptoms
Fast-acting, light-reactive genetic tools could reveal how deep brain stimulation works.
Duke University
04.28.20
Diagnostics
BIOTECON Launches SARS-CoV-2 Screening and Identification Kits
The assays are based on the WHO reference methods.
PR Newswire
04.28.20
Former GE Healthcare Executive Assumes Regulatory Role at IRADIMED
New hire also worked for Merz North America.
Globe Newswire
04.28.20
Masimo and MS Westfalia GmbH Expand Partnership
Companies to add Masimo SedLine Brain Function Monitoring, O3 Regional Oximetry to the MSW modular point-of-care hybrid Jenny.
Business Wire
04.28.20
Genalyte Announces Availability of High-Speed COVID-19 Antibody Test
First instrument-based, rapid test uses multi-antigen approach to achieve best-in-class sensitivity and specificity.
PR Newswire
04.28.20
Testing Lab to Pay Up to $43 Million for Unnecessary Test Billing
The settlement resolves allegations that Genova Diagnostics submitted false claims to Medicare, TRICARE, and the federal employee health program.
U.S. Department of Justice
04.28.20
Breaking News
HHS Releases New Performance Goals to Enhance Healthcare Cybersecurity
FDA OKs SyntheticMR's SyMRI 3D Brain Imaging
Smart Meter CEO Joins AT&T Healthcare Executive Advisory Council
Velosity Makes Commercial Enhancements for Strategic Growth
Vimal Ramjee Joins Cardio Diagnostics Holdings as Strategic Advisor
View Breaking News >
CURRENT ISSUE
March 2024
Evaluations for the EU: The Impact on Testing & Lab Services
A Matter of Fact for Medical Device Materials
The Sweet Science of Diabetes Technology
View More >