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• Cardiovascular
  

  Data Confirm the Accuracy of HeartFlow Planner in Modeling Post-PCI Outcomes

  The interactive planning tool enables heart teams to modify vessels virtually and determine the optimal treatment strategy before procedures.

  Business Wire 07.23.21
  

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  Tasso-M20 Device Earns CE Mark Certification

  Device is being used across multiple virtual clinical trials to gather unprecedented amounts of pharmacokinetic data.

  Business Wire 07.23.21
  

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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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  Venture Capital Fund Launched for Early-Stage Medical Device Firms, Products

  Fund from E-merge Capital Partners to focus on disruptive medical technologies with the potential to transform patient outcomes.

  Business Wire 07.23.21
  

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  The 2021 MPO Top 30 Medical Device Companies Report

  The COVID-19 pandemic struck the medical device industry more than most.

  Sean Fenske, Michael Barbella, & Sam Brusco, MPO Editorial Staff 07.22.21
  

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• Cardiovascular
  

  Study Data Show MobiusHD Device is a Safe Heart Failure Treatment

  Company also adds Stan Rabinovich to its Board of Directors.

  Business Wire 07.22.21
  

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• Cardiovascular
  

  Philips' Laser-Assisted IVC Filter Removal Device Earns Breakthrough Status

  Intended for ablating tissue to remove IVC filter when previous removal methods have failed.

  GlobeNewswire 07.21.21
  

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• Software & IT | Surgical
  

  Hillrom Launches Helion Integrated Surgical System in U.S.

  Provides operating room connectivity, flexibility, and efficient staff communications.

  PR Newswire 07.21.21
  

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• Cardiovascular | Digital Health
  

  Studies Show AI-Driven Blood Test Accurately Predicts Heart Attack Risk

  Data indicate the test also can correctly portend stroke and cardiac death risk.

  Business Wire 07.21.21
  

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• Electronics
  

  Electronic Medical Device Design Considerations—A Medtech Makers Q&A

  Ensuring the proper connections are made can be a greater challenge than device manufacturers may realize.

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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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• Chronic Disease
  

  Integra Highlights Data from Diabetic Foot Ulcer Study

  Positive clinical outcomes for PriMatrix dermal repair scaffold for management of hard to heal diabetic foot ulcers.

  GlobeNewswire 07.20.21
  

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• Cardiovascular
  

  CARMAT Celebrates First Aeson Artificial Heart Commercial Implant

  Represents first CARMAT sale, paves the way for the company’s commercial development.

  Business Wire 07.20.21
  

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• Cardiovascular
  

  Endologix's ChEVAS System Gains Breakthrough Status

  Investigational EVAS system designed for patients with complex abdominal aortic aneurysm.

  Business Wire 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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  MDIC Partners With Booz Allen on Device Cybersecurity

  Companies will identify best practices in cybersecurity benchmarking that can be replicated by manufacturers to ensure patient safety and security.

  Business Wire 07.19.21
  

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  Study Confirms Benefits of ZOLL's Implantable Sleep Apnea Device

  Data show sustained improvement in sleep disordered breathing, arousals, sleep architecture, and daytime sleepiness through five years.

  Business Wire 07.19.21
  

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• Chronic Disease | Software & IT
  

  Dexcom's Real-Time APIs for Third-Party Apps, Devices Earn FDA Nod

  Gives Dexcom users more choice in where and how they interact with their glucose data.

  Business Wire 07.16.21
  

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• Surgical
  

  FDA OK's Palliare's EVA15 Insufflation for Endoscopic Surgery

  Shipments of new END-200 tubeset to commence in Q4-2021.

  Business Wire 07.16.21
  

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  Aspen Laser Granted New U.S. Patent for Laser Therapy Device

  Company expanded and relocated its corporate headquarters in Utah earlier this year.

  PR Newswire 07.16.21
  

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• Patient Monitoring
  

  Philips introduces integrated Interventional Hemodynamic System

  The system features the Patient Monitor IntelliVue X3 to improve workflow and patient focus during image-guided procedures.

  Royal Philips 07.16.21
  

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• Cardiovascular
  

  HeartFlow to Go Public in $2.8B Merger Deal

  HeartFlow’s artificial intelligence-enabled software platform brings precision heart care to cardiology.

  HeartFlow Inc. 07.15.21
  

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  4 Critical Considerations for Medical Devices in a Post-Brexit UK

  Brexit impacted multiple industries, and the medical device industry was not spared.

  Online Exclusives Bruce McGill, Vice President of Global Certification, Intertek 07.15.21
  

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• Patient Monitoring
  

  Spacelabs, Masimo Partner on Patient Monitoring Advancements

  Collaboration to bring brain function monitoring, and O3 regional oximetry into select Spacelabs multi-parameter monitors.

  Business Wire 07.15.21
  

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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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  Global Enteral Feeding Devices Market to Reach $4.85 Billion by 2027

  Innovation and product launches are expected to drive growth.

  Business Wire 07.14.21
  

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• Digital Health
  

  DataRobot Launches AI for Health Incubator

  Company is accelerating critical healthcare research to help physicians and medical professionals better leverage AI.

  Business Wire 07.14.21
  

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• Patient Monitoring
  

  Survey: Patient Focus Breeds Success for Remote Cardiac Monitoring Programs

  Data show practices struggle to keep patients engaged in their care, straining staff and making it impossible for clinical and financial benefits to be realized

  Business Wire 07.14.21
  

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• Digital Health
  

  Tilak Healthcare Launches U.S. Pilot for Medical Vision Monitoring App

  The smartphone app is especially suited to monitor patients with chronic eye diseases associated with aging.

  Business Wire 07.14.21
  

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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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• Cardiovascular
  

  HeartFlow Completes Patient Enrollment in the PRECISE Trial

  More than 2,000 patients enrolled in randomized controlled trial to evaluate a precision-testing pathway for suspected coronary artery disease.

  Business Wire 07.13.21
  

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• Cardiovascular
  

  Endologix Launches ALTO Abdominal Stent Graft System in Canada, Argentina

  Company expands global reach with latest endovascular aneurysm repair technology.

  07.13.21
  

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• Patient Monitoring
  

  Canary Medical’s ‘Smart’ Implants

  MPO's Sean Fenske speaks with Dr. Bill Hunter of Canary Medical about his firm’s smart implant technology for orthopedics.

  Sean Fenske, Editor-in-Chief 07.13.21
  

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• Digital Health
  

  Heartbeat Health Raises $20 Million Series B Funding

  Money will be used to expand virtual heart care.

  Business Wire 07.12.21
  

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• Testing
  

  EAG Expands Medical Device Testing Services With New Lab

  The laboratory includes a dedicated medical device polymer analysis area.

  Business Wire 07.12.21
  

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• Digital Health
  

  ClearDATA, BioIntelliSense Collaborate to Enhance RPM Security and Compliance

  Compliant transmission of medical grade data from the home enables providers to safely monitor patients and meet demand for scalable remote care.

  Business Wire 07.09.21
  

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• Cardiovascular | Patient Monitoring
  

  FDA OKs QTc Interval Measurement for AliveCor's Personal ECG

  Long QTc interval is a potentially life-threatening side effect of certain medications.

  PR Newswire 07.09.21
  

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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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• Digital Health
  

  Philips, Cognizant Ink Digital Health Solutions Collaboration

  Pairs cloud-based healthcare platform with experience-oriented application design.

  Philips 07.09.21
  

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• Cardiovascular
  

  St. Jude Fined $27M for Allegedly Selling Defective Heart Devices

  Allegedly failed to disclose serious adverse health events in connection with premature battery depletion.

  U.S. Department of Justice 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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• Neurological
  

  Royal Philips Enters Strategic Partnership with NICO.LAB

  Advances its commitment to improving outcomes for people who suffer a stroke.

  Philips 07.08.21
  

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• Surgical
  

  USMI Developing First Robotic System for Cancer Surgery

  Stand-alone solution for robotic-assisted surgery will target open, laparoscopic/mini-invasive, endoscopic, thoracoscopic, and trans-oral surgical procedures.

  Business Wire 07.08.21
  

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• Cardiovascular
  

  Enrollment Underway in Philips' WE-TRUST Stroke Study

  Will assess impact of the Direct to Angio Suite workflow in improving patient outcomes.

  Philips 07.07.21
  

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• Cardiovascular
  

  FineHeart Successfully Implants, Removes Cardiac Device in Trial

  Study showed the device is easily removed with a beating heart 30 days after implantation without damaging the myocardium.

  Business Wire 07.07.21
  

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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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• Cardiovascular
  

  Implicity’s Cardiac Device Remote Monitoring

  MPO's Sean Fenske speaks with Dr. Arnaud Rosier of Implicity about the cardiac device monitoring solutions his company offers.

  Sean Fenske, Editor-in-Chief 07.06.21
  

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• Cardiovascular | Surgical
  

  Surmodics Buys Vetex Medical

  Adds ReVene Thrombectomy Catheter to the company's portfolio.

  Business Wire 07.06.21
  

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• Surgical
  

  Robocath Completes First Robotic Coronary Angioplasties in Belgium

  The first robotic procedures are part of a clinical study which involves six European centers.

  Robocath 07.02.21
  

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• Surgical
  

  FDA Clears Standard Bariatrics' Stapling Technology for Sleeve Gastrectomy

  The Titan SGS design ensures more consistent staple formation across the entire 23-centimeter cutline.

  PR Newswire 07.02.21
  

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