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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
  

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• Diagnostics
  

  BD Announces CE Marked Assay for HPV Screening from At-Home Self-Collected Samples

  Affords women greater access to testing.

  Charles Sternberg, Assistant Editor 05.14.21
  

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• Diagnostics
  

  New Findings Could Help Improve Pregnancy Outcomes

  Researchers have developed a model for studying uterine fluid in the lab without the need for invasive monitoring or experimentation on active pregnancies.

  Charles Sternberg, Assistant Editor 05.14.21
  

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• Diagnostics
  

  Researchers Develop AI to Predict Outcomes for Patients with Diseased Dental Implants

  The team was surprised by the types of cells associated with better outcomes for implant patients.

  Charles Sternberg, Assistant Editor 05.13.21
  

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• Diagnostics
  

  Olympus Releases New Endobronchial Ultrasound Bronchoscope

  The BF-UC190F aids physicians in diagnosing and staging lung cancer without surgery.

  Sam Brusco, Associate Editor 05.12.21
  

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• Diagnostics
  

  MatMaCorp Launches Handheld Molecular Diagnostics Tool

  Product is capable of simultaneous PCR amplification and real-time fluorescent detection, with cycle threshold values, in under an hour.

  Michael Barbella, Managing Editor 05.11.21
  

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• Diagnostics
  

  Medtronic’s Pillcam and GI Genius—A Medtech Matters Podcast

  MPO's Sean Fenske speaks with Giovanni Di Napoli of Medtronic about the company’s diagnostic technologies they are offering for the gastrointestinal space.

  Sean Fenske, Editor-in-Chief 05.11.21
  

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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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