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  Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

  Company initiates VFE testing for its porous polymer-based materials; results show components protect against certain aerosolized viruses.

  Michael Barbella, Managing Editor 01.22.21
  

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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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  FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor

  Product contains integrated sensor technologies designed to measure patient activity, heart rate, and body temperature.

  PR Newswire 01.14.21
  

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  Rapid Screening App Uses Wearable Sensor Data to Detect COVID-19 Infection

  New screening tool proves almost twice as effective as temperature checks in predicting coronavirus.

  NeuTigers 01.13.21
  

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  New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System

  The results show the device effectively delivers dose volumes up to 5 mL subcutaneously.

  B3C newswire 01.08.21
  

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  VivaLNK Expands its Medical Data Platform

  The platform boasts more than 90 healthcare solution partners across 22 countries amid an increase in remote patient monitoring adoption.

  VivaLNK 01.07.21
  

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  Rapid Adoption of AI Could Cause Problems Due to Biased Data

  Some algorithms designs could ignore how numerous factors such as sex, gender, age or existing conditions can impact health.

  GlobalData 12.07.20
  

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  Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon

  No difference in mortality between patients treated with Philips' Stellarex drug-coated balloon and those treated with percutaneous angioplasty.

  Royal Philips 12.03.20
  

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  First National Pediatric Cardiac Screening Database is Established

  FDA, industry, and patient advocacy groups join effort to advance effective cardiac screening.

  Business Wire 11.30.20
  

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• Chronic Disease
  

  Medtronic Launches InPen with Real-Time Guardian Connect CGM Data

  Real-time glucose data coupled with InPen’s dose calculator helps users make better dosing decisions.

  Medtronic plc 11.12.20
  

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• Chronic Disease
  

  Varian Invests $10M in COTA to Boost Data-Driven Cancer Care

  Companies will work together to empower cancer clinics with data analytics and decision support tools.

  PR Newswire 11.10.20
  

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• Electronics
  

  Big Data's Role in Sensor Design

  Insight into device use is driving trends in miniaturization, low-power options, and conversion to digital sensing.

  Online Exclusives Michael Barbella, Managing Editor 11.09.20
  

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  physIQ, Purdue University Studying Feasibility of COVID-19 Detection Through Smartwatch Data

  Data from the study will inform new algorithms to be developed by physIQ, a Purdue-affiliated digital health technology company.

  Business Wire 11.09.20
  

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  Report: Nearly Three-Quarters of mHealth Apps Vulnerable to Data Breach

  Findings also conclude that a majority of mHealth apps contain multiple security issues with data storage.

  Business Wire 11.05.20
  

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• Cardiovascular
  

  The Heart of the Matter: Trends in Cardiology

  Of the three major segments of coronary stents, bioabsorbable stents are expected to have the highest growth between now and 2022.

  Maria Shepherd, President and Founder, Medi-Vantage 11.04.20
  

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  ERT and Science 37 Partner to Deliver High-Quality Data During Virtual Trials

  Alliance enables trial sponsors to improve imaging, respiratory, and cardiac safety data quality while reducing patient burden and risk.

  ERT 10.08.20
  

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• Digital Health
  

  Medidata Launches Centralized Statistical Monitoring Solution for Clinical Trials

  Medidata Detect identifies known and unknown risks, and triggers corrective actions.

  Business Wire 10.05.20
  

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• Surgical
  

  Hype or Hope? The Future of Surgical Robotics

  Recent publications suggest the U.S. performs more robotic surgery than every other country in the world.

  Maria Shepherd, President and Founder, Medi-Vantage 10.01.20
  

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• Software & IT
  

  Adopting a Data-Driven Approach to Quality with an MDQMS

  FlexLogical is making quality a competitive advantage through its software solution.

  Online Exclusives Jon Speer, Founder and VP of QA/RA, Greenlight Guru 09.24.20
  

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  RapidAI Marks One Millionth Scan Leveraging Big Data

  The milestone gives RapidAI the ability to leverage more statistical power and data to enhance performance and improve patient care.

  Business Wire 09.22.20
  

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• Diagnostics | Electronics
  

  Smart E-Skin, Robotic Hand Could Gather Vital Diagnostic Data

  Relies on easily manufacturable rubber semiconductor.

  University of Houston 09.17.20
  

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• Neurological
  

  Gentle Probes Could Enable Massive Brain Data Collection

  NIH awards $4.15 million grant to maximize use of devices based on flexible nanoelectronic thread.

  Mike Williams, Rice University 09.16.20
  

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• Diagnostics
  

  FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data

  Shows Limit of Detection of over 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel.

  U.S. Food and Drug Administration 09.16.20
  

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• Contract Manufacturing | R&D & Design
  

  Trends for Medtech Contract R&D and Manufacturing

  Over the past 10 years, medtech manufacturers from startups to giants have grown their levels of outsourcing to contract R&D and manufacturing partners.

  Maria Shepherd, President and Founder, Medi-Vantage 09.01.20
  

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• Cardiovascular
  

  Data Reconfirms Long-Term Safety of Philips Stellarex Low-Dose Drug-Coated Balloon

  The mortality rate at four years shows no statistical difference between two patient groups.

  Royal Philips 08.27.20
  

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• Cardiovascular
  

  Elixir Medical Touts Positive 12-Month Data for DynamX Coronary Bioadaptor System

  Data show no target vessel revascularization, no thrombosis, and positive adaptive remodeling of the artery.

  Business Wire 08.26.20
  

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  Real-World Data for Medtech Approval Reduces Time to Market in China

  The Chinese market is forecast to grow 5.6 percent over the next five years.

  GlobalData 08.05.20
  

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  Study Data for LimFlow System Shows Excellent Amputation-Free Survival

  The minimally-invasive LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood into the foot via the veins.

  Business Wire 07.20.20
  

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• Cardiovascular
  

  FDA Approves Data Streaming from Abiomed's Impella Console

  Sets the stage for AI algorithms to further improve patient outcomes.

  Business Wire 07.17.20
  

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• Diagnostics

  FDA to Harness Real-World Data to Inform COVID-19 Response Efforts

  The FDA will participate in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.

  U.S. Food and Drug Administration 06.19.20
  

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• Software & IT
  

  Avoiding the Ripple Effect of Bad Data: Humans and Machines

  Part 3: Using process automation to reduce human error.

  Online Exclusives Terrance Holbrook, Director of Product at MasterControl 06.17.20
  

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• Software & IT
  

  Avoiding the Ripple Effect of Bad Data: Systems and Data

  Part 2: Integrating disconnected data systems.

  Online Exclusives Terrance Holbrook, Director of Product at MasterControl 06.17.20
  

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• Software & IT
  

  Avoiding the Ripple Effect of Bad Data: Quality and Manufacturing

  Part 1: Why going paperless is essential.

  Online Exclusives Terrance Holbrook, Director of Product at MasterControl 06.17.20
  

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• Chronic Disease
  

  Medtronic Presents Pivotal Trial Data for MiniMed 780G Advanced Hybrid Closed Loop System

  Data from two clinical trials demonstrates positive results for patients with type 1 diabetes.

  Globe Newswire 06.15.20
  

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  How Are MPO’s Top 30 Addressing COVID-19?

  J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.

  Online Exclusives Sam Brusco, Associate Editor 06.09.20
  

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  ERA-EDTA Launches European Database of Dialysis Data

  New registry initiative collects data of dialysis patients and transplanted patients with COVID-19 in order to measure outcomes and define risk factors.

  Presswire 06.08.20
  

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• Diagnostics
  

  FDA Publicly Shares Antibody Test Performance Data

  Advancing access to trustworthy tests and the wider field of research into serology testing.

  U.S. Food and Drug Administration 06.05.20
  

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• Digital Health
  

  Hospital Advances in Digital Health Medical Technology

  It's been stated, “What the world would have taken five years to achieve was accomplished in five weeks,” regarding virtual care and the U.S. population.

  Maria Shepherd, President and Founder, Medi-Vantage 06.04.20
  

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  Early Trial Data Show Promise in Endoscopic Procedure Time Study

  A study evaluating endoscopic procedure time removing complex colorectal polyps shows superiority of Lumendi's DiLumen device over a control group.

  Business Wire 05.27.20
  

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• R&D & Design
  

  Medtech R&D Process Aided by Big Data, AI

  Digital health allows researchers and engineers to incorporate data sets of user behaviors into their prototypes during the early phases of R&D.

  Online Exclusives Michael Barbella, Managing Editor 05.13.20
  

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• Cardiovascular
  

  HRS 2020 Science: Trial Data Compares Subcutaneous ICD Therapy to TV-ICDs

  Shows that the subcutaneous ICD is non-inferior to the transvenous ICD.

  Heart Rhythm Society 05.08.20
  

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  Implandata Completes Enrollment in ARGOS-SC01 Clinical Study

  Twenty-four patients are being evaluated at healthcare institutions in Germany and Switzerland.

  B3C Newswire 05.04.20
  

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  The Next Medtech Frontier: MedTech’s COVID-19 Response

  To their credit, many involved within our industry are fixated on determining the best ways to protect the public health.

  Maria Shepherd, Medi-Vantage 05.01.20
  

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• Software & IT
  

  Creating a Sound Data Bedrock for AI

  Five best-practice tips for creating a trusted regulatory and product information asset base capable of supporting AI-enabled process improvements.

  Online Exclusives Steve Gens of Gens & Associates and Remco Munnik of Iperion Life Sciences Consultancy 04.30.20
  

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  Advancing Infection Prevention Tools

  The applications and benefits of porous polymer materials and components.

  Jack Chan, Global Marketing Director, Porex

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• Surgical
  

  FDA Update on Essure Postmarket Activities

  All unused Essure devices of which Bayer is aware have been returned to the company.

  U.S. Food and Drug Administration 04.27.20
  

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• R&D & Design
  

  Medtech R&D Must Address Outcomes in Value-Based Care

  Clinical requirements are no longer the only cornerstone of medical device development.

  Online Exclusives Michael Barbella, Managing Editor 04.24.20
  

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  GlobalData: Medtronic’s MI Business to Exhibit Slow Growth

  Aliyah Farouk, Medical Device Analyst at GlobalData offers her view.

  GlobalData 04.24.20
  

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• Electronics | Patient Monitoring
  

  Sensors Woven into a Shirt Can Monitor Vital Signs

  Comfortable, form-fitting garments could be used to remotely track patients' health.

  Massachusetts Institute of Technology 04.24.20
  

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• Diagnostics
  

  WytCote Introduces Three-Minute COVID-19 Antibody Test

  The company has applied to the FDA for Emergency Use Authorization.

  PR Newswire 04.24.20
  

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