Diagnostics
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Diagnostics
FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests
May be related to current mixing parameters of the PCR reaction mixture.U.S. Food and Drug Administration 09.20.21
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Diagnostics
Babson Diagnostics Raises $31 Million in Series B Funding
Money will be used to help drive commercialization of customer-first, highly accessible diagnostic blood testing.Business Wire 09.20.21
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Diagnostics
FDA Clears Inova Diagnostics' Digital Multi-Analyte System
The product, Aptiva, received CE marking in August 2020.PR Newswire 09.20.21
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Diagnostics
Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA
Expands precision medicine and transforms care delivery.Siemens Healthineers 09.14.21
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Diagnostics
ZOLL to Acquire Itamar Medical for $538M
Acquiring provider of home sleep apnea diagnosis solutions.Business Wire 09.13.21
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Diagnostics
Roche to Acquire Long-Term Partner TIB Molbiol
Expands PCR-test portfolio in the fight against new infectious diseases.GlobeNewswire 09.09.21
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Diagnostics
Mobile MRI Devices Could Help Reduce Backlog of Delayed Procedures
Mobile machines can be moved to where they are most needed, and allow multiple hospitals to share costs.GlobalData 09.07.21
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Diagnostics
GE Healthcare Reveals AMX Navigate Portable X-Ray System
Helps address technologist stress and strain and improve efficiency.Business Wire 09.01.21
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Diagnostics
FDA Issues EUA for BD Veritor At-Home Covid-19 Test
The test does not require a prescription, a laboratory or a long wait for results.BD 08.26.21
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Diagnostics
Vivante Health Expands Product Suite by Unveiling GIMate
Handheld breath hydrogen monitor measures hydrogen concentration in the breath.PR Newswire 08.26.21
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Diagnostics
EchoNous’ Lexsa Linear Probe Cleared by FDA
An ultra-portable device capable of producing diagnostic-quality images rivaling those from larger, more expensive cart-based units.EchoNous 08.19.21
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Diagnostics
Illumina Closes $7.1B GRAIL Deal Despite Antitrust Challenges
GRAIL will remain a separate and independent unit, pending ongoing regulatory and legal review.PR Newswire 08.19.21
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Diagnostics
FDA Extends EUA for Spectrum Solutions’ SDNA-1000 Saliva Collection Device
New authorization includes the unsupervised self-collection of saliva for COVID-19 testing.Spectrum Solutions 08.18.21
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Diagnostics
SyntheticMR Extends Collaboration Agreement with Siemens Healthineers
Enables Siemens Healthineers to market, sell and distribute SyntheticMR’s product package SyMRI NEURO to its customers in global markets.SyntheticMR 08.18.21
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Diagnostics | Testing
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Diagnostics
Siemens Healthineers Develops COVID-19 Severity Algorithm
Helps predict the potential likelihood of progression to severe disease and life-threatening multiorgan dysfunction in COVID-19 patients.Siemens Healthineers 08.12.21
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Diagnostics
BD Launches FACSymphony A1 Benchtop Cell Analyzer
Brings sophisticated flow cytometry capabilities to laboratories of all sizes.BD 08.12.21
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Diagnostics
Regulating IVDs and LDTs—Mike on Medtech
Mike Drues and Sean Fenske discuss proposed regulations around in vitro diagnostics and lab-developed tests.Sean Fenske, Editor-in-Chief 08.10.21
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Diagnostics
HIMSS 2021: Siemens Healthineers Showcases Medicalis Patient Self-Scheduling
Enables patients to schedule their own imaging exams based on the time and location that is most convenient to them.Siemens Healthineers 08.10.21
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Diagnostics | Digital Health | Software & IT
GE Healthcare, AWS Partner to Transform Care Delivery
AI-based imaging applications and Edison Health Services platform on AWS.Business Wire 08.09.21
