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• Cardiovascular | Digital Health
  

  BioFourmis' Digital Heart Failure Therapeutic Earns Breakthrough Status

  Augments guideline-directed use of heart failure medications.

  PR Newswire 07.30.21
  

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• Cardiovascular
  

  Successful First Human Use of Foldex's Biopolymer Mitral Heart Valve

  Second product from Tria Biopolymer Valve portfolio to move into human study.

  Business Wire 07.30.21
  

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• Cardiovascular | Patient Monitoring
  

  Abbott Rolls Out Jot Dx Insertable Cardiac Monitor

  Device has option to control the amount of electronic data received for irregular heart rhythms.

  Abbott Laboratories 07.30.21
  

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• Diagnostics
  

  KA Imaging Forges U.S. Distribution Deal With Alpha Imaging

  Alpha Imaging serves 14 states in the Northeast, mid-Atlantic, and central U.S.

  KA Imaging 07.30.21
  

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• Neurological
  

  Nevro Corp Receives FDA Approval for Senza System

  The 10 kHz high frequency spinal cord stimulation therapy is designed for treatment of chronic pain associated with painful diabetic neuropathy.

  Nevro Corp. 07.29.21
  

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• Neurological
  

  Computer Algorithm Translates Brain Activity into Words and Sentences

  Restores words to a man with paralysis who is unable to speak.

  Videos

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• Surgical
  

  Baxter Buys CryoLife's PerClot Polysaccharide Hemostatic System

  Marks Baxter’s entry into the attractive global hemostatic powder segment.

  Baxter 07.29.21
  

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• Cardiovascular
  

  Bioprinted 3D Cardiac Patches Could Reverse Scar Formation

  They could also promote myocardial regeneration after heart attacks.

  American Institute of Physics 07.28.21
  

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• Cardiovascular | Patient Monitoring | Software & IT
  

  Medtronic's AI Algorithms for Cardiac Monitoring Earn FDA Nod

  AI algorithms enhance LINQ II insertable cardiac monitor diagnostic accuracy for improved patient management.

  PR Newswire 07.28.21
  

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• Surgical
  

  FDA OKs Asensus Surgical's Articulating Instruments

  Expands dexterity and adds capability to Senhance Surgical System.

  Business Wire 07.28.21
  

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• Digital Health
  

  Biospectal Initiates Studies of its Blood Pressure Measurement App

  Studies include the integration of Biospectal OptiBP and focus on routine blood pressure measurement as well as assessment of hypertension during pregnancy.

  Biospectal 07.28.21
  

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• Diagnostics
  

  Breakthrough Device Designation Granted for Skin Cancer Diagnostic

  Veriskin also secures funding from the National Cancer Institute for its TruScore device.

  Business Wire 07.28.21
  

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• Chronic Disease
  

  Rice Team Building Insulin-Producing Implant for Type 1 Diabetes

  JDRF funds creation of implant to automatically regulate blood glucose levels.

  Jade Boyd, Rice University 07.27.21
  

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• Patient Monitoring
  

  FDA OKs LifeSignals' LX1550 Multiparameter Remote Monitoring Platform

  Delivers continuous remote patient vital signs monitoring in both hospital and home.

  PR Newswire 07.27.21
  

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• Surgical
  

  BD Acquires Tepha to Expand Soft Tissue Repair and Regeneration

  Tepha is a developer and manufacturer of proprietary resorbable polymer technology.

  PR Newswire 07.27.21
  

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• Surgical
  

  Intersect ENT Rolls Out VenSure Balloon Sinus Dilation, Cube Navigation

  Join portfolio of localized drug delivery creating an integrated offering of ENT technologies to treat CRS.

  Business Wire 07.26.21
  

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• Diagnostics
  

  Quidel, Beckman Coulter End Ongoing BNP Business Litigation

  Quidel to receive cash payments between $70 million to $75 million per year through 2029.

  Business Wire 07.26.21
  

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• Cardiovascular | Surgical
  

  Medtronic Launches Prevail DCB in Europe

  Prevail DCB is used during percutaneous coronary intervention procedures.

  PR Newswire 07.26.21
  

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• Diagnostics
  

  Global PCR Tech Market to Hit $11.04 Billion by 2027

  But high manufacturing costs and prolonged time period for test results will continue to negatively impact the sector.

  Globe Newswire 07.26.21
  

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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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