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  Optimize EP Launches CaRM Cardiac Device Data Management Platform

  Digital tool automates workflow processes and enhances data algorithms to efficiently improve patient care.

  Accesswire 01.15.21
  

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• Cardiovascular
  

  U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

  The use of TAVR over open surgical techniques for replacing an aortic valve has exploded globally in recent years.

  GlobalData 01.15.21
  

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• Neurological
  

  Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

  Next-generation digital therapeutic is designed for the treatment of Alzheimer’s disease.

  Business Wire 01.14.21
  

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• Surgical
  

  Moon Surgical Expands Leadership Team

  Adds Jeffery Alvarez, David Noonan, and Nicolas Linard.

  Moon Surgical 01.14.21
  

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  Surge Period Expected for ERCP and PTC Devices Market

  But the boost will not offset revenue losses due to COVID-19.

  GlobalData 01.14.21
  

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• Diagnostics
  

  Rapid Antigen Tests Manufacturer Acquires BIOLAB

  Deal will create jobs and increase Innova's U.S. COVID-19 test kit manufacturing capability.

  Innova Medical Group Inc. 01.14.21
  

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• Neurological
  

  Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson's

  First-of-its-kind study tests automated therapy that responds to brain signals in Parkinson's patients.

  PR Newswire 01.14.21
  

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• Diagnostics
  

  PerkinElmer's SARS-CoV-2 RT-PCR Assay Earns EUA for Asymptomatic Testing

  Gold-standard testing of individuals without COVID-19 symptoms key to controlling the spread.

  Business Wire 01.14.21
  

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• Diagnostics
  

  High-Volume COVID Antigen Test Receives FDA EUA

  Ortho’s Vitros can run up to 130 tests per hour and helps address testing backlogs, supply shortages, and delayed results.

  Ortho Clinical Diagnostics 01.13.21
  

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  CMS Expedites Breakthrough Device Access; Industry Applauds

  New rule creates an accelerated Medicare coverage pathway for innovative products that the FDA deems ‘breakthrough.’

  MPO Staff 01.13.21
  

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• Patient Monitoring
  

  Valencell Launches Blood Pressure Monitoring Tech

  New technology can be built into a myriad of devices to provide accurate blood pressure readings.

  Valencell 01.13.21
  

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• Diagnostics
  

  Researchers Develop Chip That Can Detect COVID-19 Antibodies in a Minute

  New diagnostic platform could be a valuable tool for detecting exposure to multiple viruses.

  Bob Marcotte, University of Rochester 01.13.21
  

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• Cardiovascular
  

  WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

  Company adds to portfolio of 40 patents for catheter-based technology that leverages the power of the body’s natural fluid removal process.

  Business Wire 01.13.21
  

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• Digital Health | Software & IT
  

  FDA Releases Artificial Intelligence, Machine Learning Action Plan

  Outlines FDA’s next steps toward furthering oversight for AI/ML-based "software as a medical device."

  U.S. Food and Drug Administration 01.13.21
  

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• Diagnostics
  

  Abbott to Supply Additional 30M COVID-19 Tests to U.S. Gov't

  Company is in final stages of completing its self-funded capacity expansion across U.S. manufacturing sites.

  PR Newswire 01.13.21
  

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• Chronic Disease | Digital Health | Patient Monitoring
  

  Teladoc Health, Dexcom Launch CGM Tech, Personalized Insights for Type 2 Diabetes

  CGM-powered insights offer complete health profile, recommendations that support ongoing diabetes management.

  GlobeNewswire 01.13.21
  

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• Patient Monitoring
  

  Unique Contact Lens Sensor System & Manufacturing Process Developed

  New multifunctional lens can provide diversified signals from eyes.

  Surrey University 01.12.21
  

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  Researchers Receive Funding to Develop Smart Vaccine Device

  New smart patch will deliver the COVID-19 vaccine and measure its efficacy through monitoring the body's associated response.

  Swansea University 01.12.21
  

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• Surgical
  

  Medtech Matters: Talking Robotic Surgery with Zimmer Biomet

  MPO's Sean Fenske speaks with Liane Teplitsky of Zimmer Biomet about the firm’s efforts in robotic surgery and its Rosa System.

  Sean Fenske, Editor-in-Chief 01.12.21
  

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• Neurological | Surgical
  

  FDA OKs ClearMind Biomedical's Axonpen Neuroendoscope

  Requires only a narrow channel of 6.5mm through the skull for insertion into the brain.

  PR Newswire 01.12.21
  

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• 

  CarThera Starts New Clinical Trial to Test its SonoCloud-9 Device

  Study will determine the safe dose of Abraxane to be used with SonoCloud-9 in recurrent glioblastoma patients.

  CarThera 01.12.21
  

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• Patient Monitoring
  

  Itamar Medical Acquires Spry Health Tech, Assets

  Leverages Spry’s technology to bring to market first device for continuous remote patient monitoring of sleep apnea.

  GlobeNewswire 01.12.21
  

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• Patient Monitoring
  

  CES News: Philips Highlights Healthcare at Home

  Participates in the first-ever all-digital CES 2021.

  Royal Philips 01.11.21
  

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• Diagnostics
  

  Olympus and Hitachi Sign Five-Year Contract

  Will jointly develop Endoscopic Ultrasound Systems.

  Olympus Corporation 01.11.21
  

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• Diagnostics
  

  ForaCare Suisse AG Launches COVID-19 Antigen Rapid Test

  Provides fast, accurate, and easy-to-interpret test results.

  PRNewswire 01.11.21
  

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• Diagnostics | Neurological
  

  FDA OKs Abbott's First-of-Its-Kind Rapid, Handheld TBI Test

  Produces a result within 15 minutes after a plasma sample is inserted.

  Abbott Laboratories 01.11.21
  

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• Diagnostics
  

  SARS-CoV-2 Mutation Prompts FDA Alert

  Impact remains low, but false negative results can occur with any molecular test.

  U.S. Food and Drug Administration 01.11.21
  

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• Diagnostics
  

  CareDx Partners with IDbyDNA

  Will develop AlloID, a transplant patient-specific metagenomic infectious disease test platform.

  Globe Newswire 01.08.21
  

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• Diagnostics
  

  Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA

  Helps identify severe inflammatory immune responses in patients confirmed to have COVID-19.

  Siemens Healthineers 01.08.21
  

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• Cardiovascular
  

  Acutus Medical Launches AcQCross Transseptal System in Europe

  The product is designed to improve safety and efficiency in any procedure requiring left heart access.

  Globe Newswire 01.08.21
  

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• 

  Solvay Partners With PrinterPrezz on 3D Printing for Medical Devices

  Companies are collaborating on 3D printing selective laser sintering (SLS) solutions for implants and other medical devices.

  Solvay 01.08.21
  

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• Diagnostics
  

  Quantitative Transmission Ultrasound Outperforms Mammography

  QT Imaging completes first-in-human study of transmission ultrasound as a new imaging technology for breast health screening.

  PRNewswire 01.07.21
  

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• Neurological
  

  BioSerenity Achieves FDA Clearance for Wearable Device System

  Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.

  PRNewswire 01.07.21
  

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• 

  Single-Use Medical Devices Reprocessing Key to Improving Environment, Public Health

  New analysis finds healthcare supply chains to be major sources of pollution and greenhouse gas emissions.

  Business Wire 01.07.21
  

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• Diagnostics
  

  University of Birmingham Researchers Invent New COVID-19 Test

  Delivers accurate results within minutes.

  University of Birmingham 01.07.21
  

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• Packaging & Sterilization | Surgical
  

  Olympus Releases ScopeLocker Endoscope Storage Cabinet

  HEPA hinged door endoscope storage system addresses infection prevention needs in busy GI suites.

  Olympus 01.06.21
  

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• Chronic Disease | Diagnostics
  

  Hologic to Buy Cancer Test Maker Biotheranostics for $230M

  Accelerates Hologic’s entry into the oncology growth market, provides new lab capabilities.

  Business Wire 01.06.21
  

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• Cardiovascular | Electronics
  

  Medtech Matters: A Non-Contact ECG Sensor

  MPO's Sean Fenske speaks with Dr. Jesse Wheeler of Draper about the R&D organization’s project involving non-contact ECG monitoring.

  Sean Fenske, Editor-in-Chief 01.05.21
  

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• Diagnostics
  

  EKF Introduces Accurate Quantitative COVID-19 Antibody Test Kit

  The test kit is one of first to detect both the presence and precise levels of COVID-19 neutralizing antibodies.

  EKF Diagnostics 01.05.21
  

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• Diagnostics
  

  Mologic COVID-19 Rapid Antigen Test Receives CE Mark Approval

  Preliminary results show 92% sensitivity and 100% specificity, compared with RT-PCR.

  Mologic Ltd 01.05.21
  

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• Diagnostics
  

  Hologic Adds 3D Ultrasound Imaging to SuperSonic MACH 40 System

  New software-based application helps clinicians visualize breast anatomy and provides detailed characterization of lesions.

  Hologic Inc. 01.04.21
  

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• Surgical
  

  FDA Clears EndoRotor to Remove Dead Pancreatic Tissue

  Treats patients with necrotic tissue resulting from complications of acute pancreatitis.

  U.S. Food and Drug Administration 01.04.21
  

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• Cardiovascular | Neurological | Surgical
  

  FDA OKs Rapid Medical's Steerable Neurovascular Guidewire

  Provides efficient access in difficult neuro and peripheral vascular procedures.

  Business Wire 01.04.21
  

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• Diagnostics
  

  Decision Diagnostics CEO Charged in COVID-19 Fraud Scheme

  Falsely claimed the company developed a 15-second test to detect COVID-19 in a finger prick sample of blood.

  United States Department of Justice 01.04.21
  

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• Cardiovascular
  

  Edwards Treats First Patient in Restore Clinical Trial

  Evaluates minimally invasive device for mitral valve disease.

  Edwards Lifesciences Corp. 12.21.20
  

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• Diagnostics
  

  Manufacturer of Rapid Antigen Tests Acquires BIOLAB

  BIOLAB acquisition will create jobs and increase Innova's U.S. COVID-19 testing capability.

  PR Newswire 12.18.20
  

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• Diagnostics
  

  FDA Authorizes Abbott's Rapid, $25 COVID-19 Test for At-Home Use

  Telehealth service will take users step-by-step through the sample collection process.

  U.S. Food and Drug Administration 12.17.20
  

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• Cardiovascular | Diagnostics
  

  Genetesis' CardioFlux Imaging Tech Gains Breakthrough Status

  Leverages room temperature magnetometers to noninvasively measure heart’s naturally-generated magnetic fields.

  Business Wire 12.16.20
  

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• Diagnostics
  

  FDA Authorizes First OTC Fully At-Home Diagnostic COVID-19 Test

  The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test.

  U.S. Food and Drug Administration 12.16.20
  

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• Diagnostics
  

  RSIP Vision Announces New Cardiac Diagnostic Tool for PoC Ultrasound Screening

  New algorithmic module provides an automated expert-level assessment of heart function for point of care medical teams.

  RSIP Vision 12.16.20
  

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