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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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Solid Growth Forecast for Global Blood Transfusion Diagnostics Market
Chronic diseases and escalating demand for donor screening are expected to bolster industry growth over the next five years.Globe Newswire 08.25.21
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Safeguard DNA Diagnostics Launches Dry Collection Swabs for COVID-19 Testing
The dry swabs are being rolled out in Philippine laboratories.Business Wire 08.24.21
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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
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Diagnostics | Digital Health | Software & IT
Verily to Focus on Healthcare AI with New Israel R&D Center
Aim to apply AI in the detection of colonic polyps.Business Wire 08.06.21
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Diagnostics
Heru Inc. Announces the Commercial Availability of re:Vive
The wearable portable solution allows physicians to collect vital clinical data anytime during a patient’s visit.Heru Inc. 08.06.21
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Diagnostics
KA Imaging Forges U.S. Distribution Deal With Alpha Imaging
Alpha Imaging serves 14 states in the Northeast, mid-Atlantic, and central U.S.KA Imaging 07.30.21
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Diagnostics
Breakthrough Device Designation Granted for Skin Cancer Diagnostic
Veriskin also secures funding from the National Cancer Institute for its TruScore device.Business Wire 07.28.21
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Diagnostics
Quidel, Beckman Coulter End Ongoing BNP Business Litigation
Quidel to receive cash payments between $70 million to $75 million per year through 2029.Business Wire 07.26.21
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Diagnostics
Global PCR Tech Market to Hit $11.04 Billion by 2027
But high manufacturing costs and prolonged time period for test results will continue to negatively impact the sector.Globe Newswire 07.26.21
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Diagnostics
BurstIQ and FlowMetric Life Sciences Launch Novel Vaccine Immune Response Test
The VaxEffect platform empowers both patients and providers to make more informed health decisions.07.23.21
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Diagnostics
Nova POC Creatinine/eGFR Method More Accurate Than Lab Method
One of the first studies to compare the accuracy of POC creatinine/eGFR devices to iohexol mGFR method yields promising results.Nova Biomedical 07.20.21
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Diagnostics
Owlstone Medical Launches Breath Testing for Digestive Health
Testing enables patients to take better control over their digestive health through a simple at-home breath test.Owlstone Medical 07.19.21
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Diagnostics
NanoDx Inc. Enters Licensing Agreement with IBM Research
Collaboration aims to enhance and expand accurate, rapid testing for several indications, including COVID-19, Traumatic Brain Injury, Sepsis and Stroke.NanoDx Inc. 07.15.21
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Diagnostics
Hologic Gains CE Mark for Saliva Samples with COVID-19 Test
Hologic has shipped over 100 million Aptima COVID-19 tests globally since spring 2020.Business Wire 07.14.21
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Diagnostics
Lumos Diagnostics Appoints Three Industry Leaders as Independent Directors
Trio brings strong knowledge of equity markets and broad corporate governance expertise to the firm.Business Wire 07.09.21
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Diagnostics
Alere to Pay $39M to Resolve False Claims Suit
Allegedly sold diagnostic devices they knew had a materially defective algorithm.U.S. Department of Justice 07.09.21
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Diagnostics
FDA OKs Siemens Healthineers' MAGNETOM Free.Max MR Scanner
Company’s smallest, most lightweight scanner uses less than 1 liter of helium and no quench pipe.Business Wire 07.06.21
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Digital Health
EXINI Diagnostics Receives CE Mark Clearance for aPROMISE
The technology allows healthcare professionals and researchers to perform quantitative assessment of prostate-specific membrane antigen.Business Wire 07.02.21
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Diagnostics
Global POC Diagnostic, Testing Market to Top $34B by 2027
The advent of advanced technologies, a growing geriatric population, and the rising prevalence of infectious as well as chronic diseases will help drive growth.Globe Newswire 07.01.21
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Solid Growth Anticipated for Global Sleep Apnea Diagnostics Market
Sector is expected to swell nearly 7 percent annually through 2027.Globe Newswire 07.01.21
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Diagnostics
How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests
Leveraging technology to improve speed to market without sacrificing quality.Online Exclusives Brandon Henning, VP of Product at Greenlight Guru 07.01.21
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Diagnostics
Face Mask Prototype Can Spot COVID-19 Infection
Sensor tech could also create clothing that detects a variety of pathogens and other threats.Anne Trafton, MIT News Office 06.30.21
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Cardiovascular | Diagnostics
Philips, CNIC Partner on New Ultra-Fast Cardiac MRI Protocol
Technique can be implemented on existing MRI scanners.Philips 06.30.21
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Diagnostics
Interventional Systems’ Miniature Medical Robot Cleared by FDA
Makes way for the European company to start building its U.S. presence.Interventional Systems 06.29.21
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Diagnostics
PixCell's Rapid Blood Test Diagnostics
MPO's Sean Fenske speaks with Hanan Ben-Asher of PixCell Medical about the opportunities enabled with rapid blood diagnostics.Sean Fenske, Editor-in-Chief 06.29.21
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Diagnostics
Abbott's Panbio Rapid COVID-19 Antigen Self-Test Earns EU Approval
Approved for sale directly to consumers and for use in adults and children with or without symptoms.Abbott Laboratories 06.28.21
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Diagnostics
DARPA Enlists University to Develop AI for Portable Ultrasound
Research team will put expert knowledge at the fingertips of frontline medics.Carnegie Mellon University 06.22.21
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Diagnostics
FDA Breakthrough Device Designation Granted for OCT Imaging System
Designation provides potential pathway to expedite adoption of transformative medical imaging technology combined with AI.Business Wire 06.09.21
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Diagnostics | Neurological | Software & IT
FDA OKs Autism Spectrum Disorder Diagnostic Aid
Cognoa ASD Diagnosis Aid uses a machine learning algorithm to evaluate patients at risk of ASD.Sam Brusco, Associate Editor 06.03.21
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Diagnostics
Widening Scope: An Endoscopy Device Report
Minimally invasive surgical techniques and AI are spawning advancements in endoscope design and function.Michael Barbella, Managing Editor 06.02.21
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Diagnostics
A One-Second Saliva-Based COVID Test
Researchers have built a microfluidic device capable of detecting the SARS-CoV-2 spike protein in a saliva sample within an astonishing one second.Sam Brusco, Associate Editor 06.02.21
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Diagnostics
BD Launches Urine Culture Application
Helps accelerate workflow and drive lab efficiency.Charles Sternberg, Assistant Editor 06.01.21
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Diagnostics
Boston Scientific Receives CE Mark for Single-Use Bronchoscope
The EXALT Model B Bronchoscope is the latest device in the company’s single-use imaging portfolio.Charles Sternberg, Assistant Editor 05.28.21
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Diagnostics
Heru Inc. Closes $30 Million Series A Financing
Advances its cloud and AI-enabled wearable vision diagnosis and therapy.Charles Sternberg, Assistant Editor 05.20.21
