Device Sectors
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Diagnostics
FDA Authorizes First Test to Detect Zika Antibodies
The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S.U.S. Food and Drug Administration 05.24.19
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Diagnostics
FDA Clears Roche to Expand Testing Menu on cobas 6800/8800 Systems for STDs
Addition of the cobas TV/MG test to the testing menu provides the flexibility to process up to four sexually transmitted infections from one patient sample.PR Newswire 05.24.19
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Diagnostics
Beckman Coulter's Blood Test Analyzers Recalled Over Risk of Inaccurate Platelet Analyzing Results
The FDA is aware of more than 2,000 laboratories in the U.S. that may be affected.U.S. Food and Drug Administration 05.24.19
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Diagnostics
FDA OKs First Extragenital Tests for Chlamydia and Gonorrhea
Hologic and Cepheid's tests spot these infections via the throat and rectum.PR Newswire 05.24.19
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Digital Health | Software & IT
System Software with Centennial Software Solutions at BIOMEDevice Boston
Zach Pfeffer discusses ways in which his company is helping medical device manufacturers get to market faster with an embedded software solution.Videos Sean Fenske, Editor-in-Chief
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Diagnostics | Patient Monitoring
FDA OKs ControlRad's Radiation Reduction Technology that Integrates into Mobile C-arms
ControlRad Trace is the only technology that can be integrated into existing mobile C-arms to reduce radiation in any fluoroscopic imaging procedure.Business Wire 05.23.19
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Diagnostics | Digital Health | Neurological | Software & IT
Smartphone App Can Help Detect Huntington's Early
The app provides its user with a series of tests in order to check the presence of the symptoms.Kaunas University of Technology (KTU) 05.23.19
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3D/Additive Manufacturing | Diagnostics
New 3D-Printed Tech Lowers Cost of Common Medical Test
The 3D-printed pipette-tip ELISA method could also help make certain medical testing available in rural or remote areas.University of Connecticut 05.23.19
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Cardiovascular | Surgical
Edwards Shares Milestones for Transcatheter Mitral Program
The company announced strategic clinical and regulatory milestones for its PASCAL transcatheter valve repair systemPR Newswire 05.23.19
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Cardiovascular
BIOTRONIK's Orsiro Demonstrates Unique Benefits in Small Vessels
A subgroup analysis of the BIO-RESORT RCT three-year data showed significant differences in efficacy in favor of Ultrathin Strut Orsiro.PR Newswire 05.22.19
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Cardiovascular | Contract Manufacturing | Electronics | Molding | Patient Monitoring
Staying Dry: Waterproofing a Heart Monitor
Comar resolves market growth needs for the myPatch sl Holter recorder while enhancing design and addressing specific demands.Online Exclusives Adrian Possumato, Principal Consultant, Medica Consulting 05.21.19
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Neurological
Wearable System to Sense and Stimulate Brain at Unprecedented Resolution
This neural interface will be capable of both recording and stimulating the brain's dynamic activity with high temporal and spatial resolution.College of Engineering, Carnegie Mellon University 05.21.19
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Cardiovascular | Software & IT | Surgical
Algorithm Steers Catheters to the Right Spot to Treat AFib
The technology doesn't require special catheters or 3D maps of the heart.Florida Atlantic University 05.21.19
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Cardiovascular | Surgical
B. Braun Interventional Launches NuDEL All-in-One Stent Delivery System
The NuDEL CP Stent Delivery System was developed in collaboration with NuMED Inc. to treat congenital heart defects.GlobeNewswire 05.21.19
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Cardiovascular | Surgical
Galt Acquires Arrotek Medical
Combination of Arrotek’s product development with Galt’s manufacturing capabilities will provide access to new segments of the Interventional market.Business Wire 05.21.19
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Cardiovascular
HeartMate 3 Heart Pump Reduces Burden of Bleeding and Stroke Rates, Eliminates Pump Thrombosis
Largest study of its kind shows newer pump far superior to predecessor.Globe Newswire 05.21.19
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Diagnostics
QIAGEN's QIAstat-Dx Syndromic Testing System Wins FDA Nod
Molecular diagnostic testing for accurate insights on hard-to-diagnose syndromes, initial launch with respiratory panel for detection of over 20 pathogens.QIAGEN 05.20.19
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Patient Monitoring
FDA Warns Against Use of Unauthorized Diabetes Management Devices
FDA is aware patients may choose to create these systems or purchase unauthorized or unapproved components or systems because of personal preference or cost.U.S. Food and Drug Administration 05.20.19
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Cardiovascular | Surgical
Philips Launches New IntraSight Interventional Applications Platform
The platform will seamlessly integrate intravascular imaging and physiology applications for image-guided procedures.GlobeNewswire 05.20.19
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Diagnostics | Software & IT
FDA OKs Body Vision's LungVision 2.0 System
Technology helps visualize, access, and biopsy small lung lesions in real time with high accuracy.PR Newswire 05.20.19
