Breaking News
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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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Bio-Rad Receives FDA Clearance for the IH-500
Agency's clearance expands the company's offering in the blood testing market.Business Wire 05.24.19
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Health Canada Approves MRI Cochlear Implant Technology
The new implant from Advanced Bionics offers a pain-free choice to recipients undergoing MRI examinations.Business Wire 05.24.19
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Insera Earns CE Mark Approval for Cyclical-suction Stroke Thrombectomy Platform
Approval was based on mechanical bench tests, safety and efficacy tests conducted in premier stroke device testing centers.Business Wire 05.24.19
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DoD Awards Pitt, CMU Contracts to Create Autonomous Robotic Trauma Care System
Autonomous trauma care system will fit in a backpack to treat and stabilize soldiers injured in remote locations.University of Pittsburgh 05.23.19
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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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Materials
High Performance Medical Compounder Opens Doors in Leominster, Mass.
Team of plastics industry veterans opens a state-of-the-art custom medical compounding and toll processing company.Peak Performance Compounding Inc. 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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Molding
Quick Launch Program for Advanced Medical Molding
The accelerated program was developed to help OEMs who are ready to move their micro medical part into production quickly.MTD Micro Molding 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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GE Healthcare Launches Edison Integration to American College of Radiology AI-LAB
Edison AI platform will integrate with ACR AI-LAB, providing ACR members and other radiology professionals with connectivity to Edison AI services.Business Wire 05.23.19
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Spry Health Receives FDA Clearance of its Loop System, Designed to Transform COPD Care
Technology aims to reduce hospital admissions, provide peace of mind to patients and caregivers.Business Wire 05.23.19
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Axonics Appoints Two New Members to its Board
The latest additions worked for J&J and Salter Labs.Business Wire 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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Canon Medical Launches New Ultrasound Product Line
New Aplio a-series delivers ultrasound market advanced technology, ergonomics and multipurpose use.Business Wire 05.22.19
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RIMSYS Regulatory Management Software Forms Advisory Board
The board members will serve as strategic partners in the company's continued development.Business Wire 05.22.19
