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  Amnovis Achieves ISO 13485 Certification for Additive Manufacturing Processes

  Supports the company’s strategic focus on high-end, quality-critical applications, including medical devices.

  Amnovis 09.28.21
  

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• Digital Health
  

  FDA Clears One-Click Segmentation and Measurement Software Tool

  The new software delivers consistent precision in all medical imaging modalities.

  DeepLook Inc. 09.28.21
  

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  Medline, RenalSense Partner to Offer UO Monitoring System

  The partnership gives RenalSense and Clarity RMS the marketing muscle required to scale current North American sales and marketing efforts.

  PR Newswire 09.28.21
  

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  TE Connectivity Acquires Three Companies

  Expands its reach into IVD, point of care, and microfluidics segments.

  TE Connectivity 09.27.21
  

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• Diagnostics
  

  Ortho Clinical Diagnostics Partners With Thermo Fisher Scientific

  Collaboration is designed to bring a complete quality control solution to the laboratory.

  PR Newswire 09.27.21
  

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• Digital Health
  

  CAIRE Introduces myCAIRE Telehealth Solution

  Next-generation application is designed to increase efficiency and improve oxygen patient care.

  Business Wire 09.27.21
  

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• 

  Gredale Acquires Majority Stake in Maskco Technologies Inc.

  Masko, a personal protective equipment startup, is valued at $4.4 billion.

  PR Newswire 09.27.21
  

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• 

  Medical Alley Welcomes Roberta Dressen as New CEO

  Dressen has nearly two decades of leadership experience with leading healthcare organizations.

  Medical Alley Association 09.24.21
  

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• 

  Explorer Surgical Launches Sales Training Platform with Remote Case Observation

  Explorer Live increasing efficiency for medical device sales teams with case experience, procedural workflow training, and knowledge assessments.

  Explorer Surgical 09.24.21
  

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• 3D/Additive Manufacturing
  

  Paragon Medical to Build New Additive Manufacturing Facility

  The Pierceton, Ind., facility will provide vertically integrated solutions that enable the firm’s customers to better serve their patients.

  Paragon Medical 09.24.21
  

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• 

  CE Mark for Nuwellis’ 24-Hour Blood Circuit Set

  Certification will help Nuwellis meet clinical and healthcare economic needs in Europe.

  Globe Newswire 09.24.21
  

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• 

  Robocath, University Partner to Improve Stroke Treatment

  Efforts will focus on the use of robotics to treat stroke victims.

  Robocath 09.24.21
  

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• 

  BiologyWorks Granted ISO 13485:2016 Certification for COVID-19 Test

  The test eliminates the need for a diagnostic laboratory, providing fast, real-time results in less than 30 minutes.

  Business Wire 09.24.21
  

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• 

  Integer to Build New Innovation and Manufacturing Facility in Galway, Ireland

  Expansion to significantly increase company’s presence and capabilities in region.

  Integer Holdings Corporation 09.24.21
  

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• 

  Understanding Wireless Device Coexistence in Medical Environments

  Element's David Schaefer will explain how wireless coexistence testing helps to mitigate the risk of interference and provide safe products for patients.

  09.23.21
  

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• 

  U.S. Patent Office Rejects More of Axionics’ Challenges in Dispute with Medtronic

  Medtronic will move to request litigation proceedings resume.

  Medtronic plc 09.23.21
  

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• 

  GE Healthcare to Acquire BK Medical

  The $1.45 billion deal expands GE Healthcare's ultrasound portfolio into surgical visualization.

  GE Healthcare 09.23.21
  

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• 

  First Patient Treated With Philips' 3D Echocardiography Catheter

  The reduced need for general anesthesia with VeriSight Pro accelerates workflows, increases efficiency, and broadens treatment options.

  Royal Philips 09.23.21
  

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• 

  MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021

  Attendees of The MedTech Conference, powered by AdvaMed, will vote for the Grand Prize winner.

  MedTech Innovator 09.21.21
  

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• 

  Boston Scientific Agrees to Acquire Devoro Medical

  Advances its efforts to ensure physicians have the right tools to improve procedural efficiencies.

  Boston Scientific 09.21.21
  

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• 

  CareDx Appoints Hannah Valantine to its Board

  Valantine is a professor of Medicine at Stanford and the former National Institutes of Health chief scientific officer for Scientific Workforce Diversity.

  Globe Newswire 09.21.21
  

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• Diagnostics
  

  FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests

  May be related to current mixing parameters of the PCR reaction mixture.

  U.S. Food and Drug Administration 09.20.21
  

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• Surgical
  

  Precision Coating Merges with N2 Biomedical

  Expands its medical coatings platform.

  Ampersand Capital Partners 09.20.21
  

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• Diagnostics
  

  FDA Clears Inova Diagnostics' Digital Multi-Analyte System

  The product, Aptiva, received CE marking in August 2020.

  PR Newswire 09.20.21
  

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• Cardiovascular
  

  FDA Approves Abbott's Portico with FlexNav TAVR System

  Self-expanding TAVR valve features intra-annular (within the native valve) leaflets.

  PR Newswire 09.20.21
  

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• 

  Sight Sciences Files Patent Suit Against Ivantis

  The company seeks injunction related to Hydrus Microstent’s infringement. .

  GlobeNewswire 09.17.21
  

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• 

  New Appointments Bring Changes to Alcon's Executive Committee

  Ian Bell to head Innovation at the company while Raj Narayanan is appointed president, International.

  Business Wire 09.17.21
  

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• Patient Monitoring
  

  VitalConnect Launches New Version of VistaCenter for Cardiac & Remote Patient Monitoring

  Brings market-leading patient management and monitoring tools to physicians.

  VitalConnect Inc. 09.16.21
  

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• 

  Improved Outcomes Proven With Insulet’s Omnipod 5 System

  Studies show the automated insulin delivery system improved HbA1c nearly one percentage point in kids and 0.60 percent in adolescents and adults.

  Business Wire 09.16.21
  

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• Surgical
  

  Vicarious Surgical Business Combination with D8 Holdings Approved

  Vicarious Surgical to debut on NYSE as disruptive next-gen surgical robotics company.

  Business Wire 09.16.21
  

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• 

  CeQur Appoints Rick Doubleday and Dr. Meret Gaugler to its Board

  New members have decades of healthcare experience.

  Business Wire 09.15.21
  

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• 

  Glaukos and Ivantis Settle Glaucoma Microstent Patent Suit

  Ivantis to pay $60 million and ongoing double-digit royalty to Glaukos.

  Business Wire 09.15.21
  

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• Surgical
  

  Molli Surgical's Breast Tumor Marker

  MPO's Sean Fenske speaks with Dr. Fazila Seker of MOLLI Surgical about the benefits of her company’s breast tumor marking system.

  Sean Fenske, Editor-in-Chief 09.14.21
  

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• Neurological
  

  Axonics Loses Three Challenges to Medtronic Patents

  Medtronic receives affirmation of three additional sacral neuromodulation patents.

  PR Newswire 09.14.21
  

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• Digital Health
  

  The Benefits of Computer Vision Technology for Healthcare Applications

  How new technology could save millions of dollars and help patients receive better treatment.

  Online Exclusives Henry Bell, Head of Product at Vendorland 09.13.21
  

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• Patient Monitoring
  

  Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe

  Uses 12 LEDs to simultaneously offer 12 blood constituent parameters noninvasively and continuously.

  Business Wire 09.13.21
  

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• Digital Health
  

  RapidAI Launches Rapid Workflow for Pulmonary Embolism

  Rapid Workflow for PE helps hospital teams align, activate and communicate about patient status to administer care faster.

  RapidAI 09.13.21
  

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• Cardiovascular
  

  OMRON Healthcare, Kyoto University Partner on Cardiovascular Disease Prevention

  Effort will focus on developing an AI-driven blood pressure management method and blood pressure analysis for early detection of cardiovascular events.

  PR Newswire 09.13.21
  

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• Diagnostics
  

  ZOLL to Acquire Itamar Medical for $538M

  Acquiring provider of home sleep apnea diagnosis solutions.

  Business Wire 09.13.21
  

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• Machining & Laser Processing
  

  Modern Machining for Medtech

  CNC machining is a well-established fabrication method, but ongoing advancements keep it as an attractive option for device makers.

  Mark Crawford, Contributing Writer 09.10.21
  

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• Contract Manufacturing
  

  Automation and Assembly for Medtech Represent a Complex Coupling

  Automated device assembly can help reduce costs and improve overall manufacturing efficiency, but manual processes are still necessary for complex tasks.

  Michael Barbella, Managing Editor 09.10.21
  

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• Electronics
  

  Custom Electronics Allow Medtech Firms to Dare to Be Different

  Half a dozen industry experts discuss medical device custom electronics design and manufacturing.

  Sam Brusco, Associate Editor 09.10.21
  

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• Electronics
  

  The World’s Smallest Biosupercapacitor: What’s the Healthcare Potential?

  Efficient energy storage devices can enable operation of microsystems that work autonomously and in more and tinier areas of the human body.

  Sam Brusco, Associate Editor 09.10.21
  

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• Chronic Disease
  

  Cancer: The Global Burden and Medtech Opportunity

  Cancer is the first or second leading cause of death for patients under 70 years old in 112 of 183 countries across the globe.

  Maria Shepherd, President and Founder, Medi-Vantage 09.10.21
  

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• 3D/Additive Manufacturing
  

  3D Printing as Art Therapy

  It’s a new-tech take on art therapy and art psychotherapy, which are both elements of the support Westwood Prep offers its students.

  Dawn A. Lissy, Founder & President, Empirical 09.10.21
  

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• 

  The New U.K. Conformity Assessment: 10 Checklist Items

  The transition to the U.K.’s new regulatory regime officially began as of the first of January 2021.

  Ed Ball, Senior Associate, RQM+ 09.10.21
  

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• 3D/Additive Manufacturing
  

  3D Printing: Separating Fantasy from Reality in Medical Device Development

  3D-printed models are excellent tools for trying out different aesthetic approaches, and can be key in both human factors and preliminary market studies.

  Peggy Fasano, Chief Operating Officer, Boulder iQ 09.10.21
  

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• 

  AI-Based Medical Devices: The Regulatory Landscape

  Artificial intelligence/machine learning (AI/ML) has wide-ranging applications within the healthcare industry.

  Danielle Besal, MS, Principal Consultant, MRC Global LLC 09.10.21
  

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• 

  Managing a Global Medtech Business Amid International Travel Challenges

  It is imperative for management teams to conduct regular “functional check-ups” on all operational activities that are impacted globally.

  Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 09.10.21
  

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• Software & IT
  

  Better Claims Management Starts at the Source

  Claims management is an essential part of commercializing a product and getting it to patients.

  Terri Howard, Director, Commercial and Medical Strategy, Veeva MedTech 09.10.21
  

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