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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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• 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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• 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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• 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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