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• Diagnostics
  

  RSIP Vision Launches Prostate MRI-to-Ultrasound Registration Tool

  Module creates a warped MRI scan that matches real-time ultrasound results to precisely locate clinically relevant regions & reduce procedural risks to patients

  Charles Sternberg, Assistant Editor 05.07.21
  

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• Diagnostics
  

  Medivolve & Marvel Diagnostics Complete First Stage Clinical Testing of BlowFISH

  The technology has entered the next phase toward applying for an EUA from the FDA to test for the COVID-19 virus.

  Charles Sternberg, Assistant Editor 05.06.21
  

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• Chronic Disease | Diagnostics
  

  GE Healthcare Buys Zionexa, a Breast Cancer Dx Startup

  Acquired molecular imaging agent aims for more targeted metastatic breast cancer treatment.

  Sam Brusco, Associate Editor 05.06.21
  

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• Diagnostics
  

  COVID Diagnostics from Beckman Coulter—A Medtech Matters Podcast

  MPO's Sean Fenske speaks with Chris Hagen of Beckman Coulter about the company’s response to the need for COVID diagnostics and the rapid ramp-up of production.

  Sean Fenske, Editor-in-Chief 05.04.21
  

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• Diagnostics
  

  Olympus Expands U.S. Bronchoscopy Portfolio

  Launches a new line of five premium endoscopes.

  Charles Sternberg, Assistant Editor 04.30.21
  

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• Diagnostics
  

  Hillrom Advances Its Physical Assessment Tools

  Launches the Welch Allyn PanOptic Plus Ophthalmoscope and MacroView Plus Otoscope.

  Charles Sternberg, Assistant Editor 04.29.21
  

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• Diagnostics | R&D & Design
  

  5 Guidelines for Productizing an Optically Based Medical Device

  Pitfalls most relevant to optical medical devices, but many are applicable to medical devices without optics.

  Online Exclusives Brian King, Principal Optical Systems Engineer, StarFish Medical 04.29.21
  

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• Diagnostics
  

  CerTest Biotec & BD Add Saliva to the Visasure SARS-CoV-2 Detection Kit

  Allows BD MAX System users more flexibility with three alternatives for specimen collection.

  Charles Sternberg, Assistant Editor 04.27.21
  

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  LG Expands Diagnostic Medical Monitor Line

  Unveils new 12-megapixel multimodality display.

  Charles Sternberg, Assistant Editor 04.23.21
  

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• Diagnostics
  

  Abbott Begins Shipping Rapid COVID Self-Tests

  Abbott to manufacture tens of millions of BinaxNOW Self Tests per month.

  Sam Brusco, Associate Editor 04.20.21
  

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• Diagnostics
  

  FDA Grants De Novo Clearance to Medtronic’s GI Genius Model

  Assists physicians in detecting pre-cancerous growths, potentially addressing 19 million colonoscopies annually.

  Charles Sternberg, Assistant Editor 04.15.21
  

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• Diagnostics
  

  DiaSorin to Buy Luminex for $1.8B

  Provides access to proven Luminex multiplexing technology and molecular testing solutions.

  Sam Brusco, Associate Editor 04.13.21
  

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• Diagnostics
  

  Avantor to Acquire Ritter GmbH and Affiliates for $1B

  Expands proprietary offering for diagnostic and drug discovery workflows.

  Sam Brusco, Associate Editor 04.12.21
  

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• Diagnostics
  

  Hologic to Buy Mobidiag for $795M

  Hologic gains near-patient, acute care diagnostic testing platforms.

  Sam Brusco, Associate Editor 04.08.21
  

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• Diagnostics
  

  EKF Launches STAT-Site WB β-Ketone and Glucose Handheld Analyzer

  Company obtains CE mark certification alongside CLIA waiver for easy-to-use whole blood analyzer for diabetes care programs.

  Michael Barbella, Managing Editor 04.07.21
  

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• Diagnostics
  

  PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market

  With smart onshoring strategies, the medical device industry can collaborate to fix supply chain issues.

  Claudio Hanna and Ralph Tricomi , Web Industries 04.01.21
  

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• Diagnostics
  

  BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing

  BD Veritor Plus System supports return-to-school and return-to-work programs through serial testing.

  Sam Brusco, Associate Editor 04.01.21
  

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• Diagnostics
  

  Abbott's Rapid COVID-19 Self-Test Receives EUA

  Permits asymptomatic, non-prescription, over-the-counter self-use for people with or without symptoms.

  Sam Brusco, Associate Editor 04.01.21
  

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• Diagnostics
  

  Diagnosing the IVD Market: An Interview with TEAM Technologies

  Chief revenue officer Steve Lents discusses the in-vitro diagnostic market and manufacturing rapid antigen POC COVID-19 tests.

  Online Exclusives Sam Brusco, Associate Editor 03.30.21
  

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• Diagnostics
  

  BD's Combo COVID-19, Flu Rapid Antigen Test Earns EUA

  Can detect SARS-CoV-2, influenza A, influenza B from a single patient sample in 15 minutes.

  Sam Brusco, Associate Editor 03.30.21
  

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• Diagnostics
  

  FDA OKs GE Healthcare's New 3D Surgical Imaging System

  OEC 3D brings precise 3D and 2D imaging to surgical suites, improving efficiency.

  Sam Brusco, Associate Editor 03.25.21
  

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• Diagnostics
  

  Optellum Receives FDA Clearance for Virtual Nodule Clinic

  Empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is now commercially available in the U.S.

  Charles Sternberg, Assistant Editor 03.23.21
  

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• Diagnostics
  

  FDA Authorizes Machine Learning-Based COVID-19 Biomarker Screening Device

  Identifies biomarkers that may be indicative of SARS-CoV-2 infection as well as other hypercoagulable conditions.

  Sam Brusco, Associate Editor 03.23.21
  

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  FDA Breakthrough Device Designation Granted to Machine Learning Diagnostic Method

  Algorithm developed for earlier detection of gastrointestinal bleeding.

  Michael Barbella, Managing Editor 03.18.21
  

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• Diagnostics
  

  GE Healthcare Reveals Vscan Air Wireless, Handheld Ultrasound

  Touts dual-probe whole-body scanning capabilities.

  Sam Brusco, Associate Editor 03.17.21
  

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• Diagnostics
  

  FDA OKs Olympus' Narrow Band Imaging to Assess Colonic Lesions

  New evidence supports NBI to characterize polyps found during screening colonoscopies for colorectal cancer.

  Sam Brusco, Associate Editor 03.16.21
  

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• Diagnostics
  

  Roche to Acquire GenMark Diagnostics for $1.8B

  GenMark’s syndromic panel testing portfolio complements Roche’s current molecular diagnostics portfolio.

  Sam Brusco, Associate Editor 03.15.21
  

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  In vitro diagnostics Automation of point-of-care devices

  Get ready for market launches faster by working together to develop ready-to-install automation solutions.

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• Diagnostics
  

  FDA Issues EUA to First OTC Home Molecular COVID-19 Test

  Results from the Cue COVID-19 test are sent directly to a companion app in about 20 minutes.

  Sam Brusco, Associate Editor 03.08.21
  

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• Diagnostics
  

  Avacta’s Rapid Antigen Test Proves Effective for New Coronavirus Variants

  Detects the B117, or ‘Kent’, variant, and the D614G variant, as well as the original strain.

  Charles Sternberg, Assistant Editor 03.08.21
  

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• Diagnostics
  

  EUA Granted for New COVID-19, Flu A, Flu B Combo Kit

  One multiplex real-time PCR diagnostic kit can simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B.

  Michael Barbella, Managing Editor 03.05.21
  

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• Diagnostics
  

  EchoNous Expands Its Kosmos Hardware Platform

  Adds continuous wave and pulsed wave Doppler capabilities.

  Charles Sternberg, Assistant Editor 03.04.21
  

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• Diagnostics
  

  Diagnostic Desperation: A Look at IVD Trends During COVID-19

  Diagnostics manufacturers and supply chain partners have adapted to accommodate the enormous demand for COVID-19 tests amid disrupted operations.

  Sam Brusco, Associate Editor 03.04.21
  

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• Chronic Disease | Diagnostics
  

  Bio-Techne to Acquire Asuragen for $320M

  Bio-Techne gains genetic carrier screening and oncology testing kits.

  Sam Brusco, Associate Editor 03.04.21
  

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• Diagnostics | Digital Health
  

  Philips, Disney Join Forces to Reduce Childrens' MRI Anxiety

  Will explore effects and use of animated stories and characters, including Disney favorites, as part of Philips Ambient Experience solution.

  Sam Brusco, Associate Editor 03.03.21
  

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• Diagnostics
  

  Quidel's QuickVue At-Home COVID-19 Test Earns EUA

  Easy-to-use at-home test provides results in ten minutes with a doctor’s prescription.

  Sam Brusco, Associate Editor 03.02.21
  

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• Diagnostics
  

  Hologic Buys Molecular Dx Firm Diagenode for $159M

  Diagenode brings more than 30 CE-marked, real-time PCR tests.

  Sam Brusco, Associate Editor 03.02.21
  

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  Canada Authorizes COVID-19 Diagnostic Assay That Boosts Virus Testing Efficiency

  The product is compatible with Thermo Fisher Scientific's Amplitude platform.

  Michael Barbella, Managing Editor 02.25.21
  

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• Diagnostics
  

  SpinTech Inc. Acquires MR Innovations

  Includes an expert team of engineers and physicists and MR Innovations' patents, published papers and network of global collaborators.

  Charles Sternberg, Assistant Editor 02.24.21
  

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• Diagnostics
  

  Rice University Researchers Receive Funding to Develop Covid-19 Sensor System

  Real-time electronic system will be able to detect minute amounts of SARS-CoV-2.

  Charles Sternberg, Assistant Editor 02.22.21
  

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• Diagnostics
  

  BD Collaborates with Scanwell Health

  Aims to create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.

  Charles Sternberg, Assistant Editor 02.22.21
  

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• Diagnostics
  

  Study Validates Vocalis Health’s COVID-19 Screening Tool

  VocalisCheck obtains CE mark approval for medical use.

  Charles Sternberg, Assistant Editor 02.18.21
  

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• Diagnostics
  

  Test Identifies COVID-19 Patients at Increased Risk of Intubation With Mechanical Ventilation

  The assay is currently available in Europe.

  Michael Barbella, Managing Editor 02.16.21
  

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• Diagnostics
  

  FDA Authorizes Luminostics' 30-Minute Smartphone-Based COVID-19 Test

  Luminostics is ramping up production with a target capacity of four million+ tests per month by summer.

  Videos Sam Brusco, Associate Editor

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• Diagnostics
  

  FDA Grants EUA to Bio-Rad Reliance Assay Kits

  Help physicians more easily detect and differentiate SARS-CoV-2 in patients.

  Charles Sternberg, Assistant Editor 02.16.21
  

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• Diagnostics
  

  Medtech Matters: Hologic’s Breast Health Happenings

  MPO's Sean Fenske speaks with Jennifer Meade of Hologic about the company’s recent M&A as well as its initiatives in women’s health.

  Sean Fenske, Editor-in-Chief 02.16.21
  

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• Diagnostics | Digital Health | Software & IT
  

  Pioneering AI Solutions to Reinforce Healthcare Services

  Can AI live up to its hype in the healthcare landscape?

  Online Exclusives Sunil Jha, Senior Research Content Developer, Global Market Insights 02.12.21
  

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• Diagnostics
  

  Suitcase Laboratory to Detect COVID-19 in Development

  Mobile laboratory for rapid detection of SARS-CoV-2 for Africa.

  Sam Brusco, Associate Editor 02.12.21
  

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• Diagnostics
  

  BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test

  Also shows ability to detect U.K., South African variants of COVID-19.

  Sam Brusco, Associate Editor 02.12.21
  

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• Diagnostics
  

  ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing

  System can be used for COVID-19, Influenza A & B, and other viruses.

  Charles Sternberg, Assistant Editor 02.09.21
  

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