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• Digital Health
  

  Real-World Medical Device Hacking Tales

  MPO's Sean Fenske gains some insights from Alan Grau of Sectigo on examples of real-world healthcare device hacking incidents and the details involved.

  Videos Sean Fenske, Editor-in-Chief

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• Diagnostics
  

  FDA Grants De Novo Clearance to Medtronic’s GI Genius Model

  Assists physicians in detecting pre-cancerous growths, potentially addressing 19 million colonoscopies annually.

  Charles Sternberg, Assistant Editor 04.15.21
  

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  Portable Medical Devices Market to Reach $100 Billion by 2027

  Sector to grow 8.5 percent annually over the next six years, driven by an increased awareness of overall health and fitness.

  Michael Barbella, Managing Editor 04.15.21
  

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• Chronic Disease
  

  BD Receives 510(k) Clearance for Pristine Catheter

  The clearance was supported by clinical data from a feasibility study with favorable primary patency rates observed out to 180 days.

  Charles Sternberg, Assistant Editor 04.15.21
  

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• Chronic Disease
  

  Medtronic Introduces Extended Infusion Set in Europe

  Can be worn for up to seven days so users can safely stay on insulin pump therapy with fewer interruptions and insertions.

  Charles Sternberg, Assistant Editor 04.14.21
  

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• Cardiovascular | Software & IT
  

  BioSig Launches Software Update for PURE EP Electrophysiology Platform

  The upgrade includes enhanced signal processing for advanced cardiac signal analysis.

  Sam Brusco, Associate Editor 04.14.21
  

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• Surgical
  

  Katena Acquires Ophthalmic Surgical Instrument Maker ASICO

  Katena obtains high-quality ophthalmic surgical instruments.

  Sam Brusco, Associate Editor 04.14.21
  

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• Diagnostics
  

  DiaSorin to Buy Luminex for $1.8B

  Provides access to proven Luminex multiplexing technology and molecular testing solutions.

  Sam Brusco, Associate Editor 04.13.21
  

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• Cardiovascular
  

  Endologix Acquires PQ Bypass

  Gains proprietary Detour platform for percutaneous femoral-popliteal bypass.

  Sam Brusco, Associate Editor 04.13.21
  

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• Cardiovascular
  

  Elixir Medical Begins Study of Metallic Implant for CAD Treatment

  Product is designed to adapt to vessel physiology.

  Michael Barbella, Managing Editor 04.13.21
  

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• Digital Health
  

  A Digital Stethoscope & Digital Health—A Medtech Matters Podcast

  MPO's Sean Fenske speaks with Clive Smith of Thinklabs about his digital stethoscope and how it was used during the pandemic.

  Sean Fenske, Editor-in-Chief 04.13.21
  

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• Diagnostics
  

  Avantor to Acquire Ritter GmbH and Affiliates for $1B

  Expands proprietary offering for diagnostic and drug discovery workflows.

  Sam Brusco, Associate Editor 04.12.21
  

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• Neurological
  

  ZOLL Buys Sleep Apnea Device Maker Respicardia

  Respicardia's remedē system, an implantable neurostimulator, treats central sleep apnea.

  Sam Brusco, Associate Editor 04.12.21
  

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• Digital Health
  

  Digital Diabetes Management Market Projected to Reach $54 Billion by 2027

  Asia Pacific's annual growth rate is expected to skyrocket 19.5 percent, according to data.

  Michael Barbella, Managing Editor 04.12.21
  

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• Chronic Disease | Software & IT
  

  Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy

  Firms will collaborate to build AI tools for radiation oncology organ segmentation using the Google Cloud AI Platform.

  Sam Brusco, Associate Editor 04.09.21
  

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  Masimo Device is Useful in Assessing Respiratory Status of Pediatric Tracheostomy Patients

  EMMA Capnography can be used in home-care settings and outpatient departments.

  Michael Barbella, Managing Editor 04.09.21
  

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• Cardiovascular
  

  USPTO Issues Patent Covering Hancock Jaffe’s VenoValve

  Valve is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency (CVI).

  Charles Sternberg, Assistant Editor 04.08.21
  

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• Cardiovascular
  

  Digging into the Cardiac Arrhythmia Monitoring Device Market

  The overall market is set to reach an annual valuation of $9 billion by 2026.

  Online Exclusives Saloni Walimbe, Research Content Developer, Global Market Insights 04.08.21
  

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• Cardiovascular | Surgical
  

  Abbott's Next-Gen TriClip Earns EU Nod

  New enhancements to first-of-its-kind device uniquely developed for the difficult-to-treat tricuspid valve.

  Sam Brusco, Associate Editor 04.08.21
  

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• Diagnostics
  

  Hologic to Buy Mobidiag for $795M

  Hologic gains near-patient, acute care diagnostic testing platforms.

  Sam Brusco, Associate Editor 04.08.21
  

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• Surgical
  

  Bausch + Lomb's ClearVisc Dispersive Ophthalmic Viscosurgical Device Approved

  Offers corneal protection and visibility during ophthalmic surgery.

  Sam Brusco, Associate Editor 04.07.21
  

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  Berlin Heals' C-MIC Heart Failure Implant Achieves Breakthrough Device Status

  Company initiates an early feasibility study in the United States.

  Michael Barbella, Managing Editor 04.07.21
  

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• Digital Health
  

  Cloud and AI Accelerating Global Medical Imaging Informatics Market

  Modern informatics solutions will drive revenue in developed markets, according to Frost & Sullivan.

  Michael Barbella, Managing Editor 04.07.21
  

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• Diagnostics
  

  EKF Launches STAT-Site WB β-Ketone and Glucose Handheld Analyzer

  Company obtains CE mark certification alongside CLIA waiver for easy-to-use whole blood analyzer for diabetes care programs.

  Michael Barbella, Managing Editor 04.07.21
  

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• Surgical
  

  Royal Philips’ SmartCT Application Software Receives FDA 510(k) Clearance

  Helps enhance clinical confidence, smooths workflows, and increases productivity.

  Charles Sternberg, Assistant Editor 04.06.21
  

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• 

  Former FDA Lawyer to Lead TSG Consulting's Medical Device Practice

  Laurie Clarke has represented medical device companies ranging from small startups to multi-national corporations on complex regulatory matters.

  Michael Barbella, Managing Editor 04.06.21
  

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• Chronic Disease | Digital Health | Patient Monitoring
  

  Welldoc, Dexcom Expand Strategic Partnership for Diabetes Management

  Companies to integrate CGM, lifestyle management platforms to offer integrated type 2 diabetes solution.

  Sam Brusco, Associate Editor 04.05.21
  

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• Cardiovascular
  

  Cardiovascular Device Market Expands to Tackle Higher Disease Burden

  The market is likely to exceed a valuation of $10 billion by 2027.

  Online Exclusives Vinisha Joshi, Research Content Developer, Global Market Insights 04.01.21
  

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• Cardiovascular | Surgical
  

  Home Is Where the Heart (Valve) Is

  Artificial heart valve makers reached a number of milestones despite the pandemic’s global squeeze.

  Sam Brusco, Associate Editor 04.01.21
  

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• Chronic Disease | Digital Health | Patient Monitoring
  

  CGM: Digital Health Meets a Very Large Opportunity

  Continuous glucose monitors (CGMs) are one of the most formidable diabetes management tools to be developed in decades.

  Maria Shepherd, President and Founder, Medi-Vantage 04.01.21
  

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• Surgical
  

  Biomechanical Engineer, Heal Thyself

  Choosing a treatment option for spinal disorders can be tricky with extensive knowledge of the industry.

  Dawn A. Lissy, Founder & President, Empirical 04.01.21
  

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• Molding | Surgical
  

  Optimizing MIM in Medical Device Manufacturing

  Metal injection molding (MIM) is a good choice for producing medium- to high-volume medtech parts.

  Steve Santoro, Executive Vice President, MICRO 04.01.21
  

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• Diagnostics
  

  PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market

  With smart onshoring strategies, the medical device industry can collaborate to fix supply chain issues.

  Claudio Hanna and Ralph Tricomi , Web Industries 04.01.21
  

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• Testing
  

  The Evolution of Chemical Characterization for Medical Devices

  Evaluation of biological safety of devices is experiencing some of the most significant changes in history.

  Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Medical Device Testing 04.01.21
  

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• Digital Health
  

  How Digital Health Fits into the Medtech Mold

  Healthcare will need to adopt digital technologies that streamline and enhance connectivity.

  Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 04.01.21
  

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• Surgical
  

  Ethicon Launches Echelon+ Stapler

  Increases staple line security and reduces complications in surgery.

  Charles Sternberg, Assistant Editor 04.01.21
  

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• Digital Health | Patient Monitoring | Software & IT
  

  Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

  Telemedicine has thrived during COVID-19 but its post-pandemic momentum will depend on regulatory changes, connectivity parity, and improved interoperability.

  Michael Barbella, Managing Editor 04.01.21
  

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• Diagnostics
  

  BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing

  BD Veritor Plus System supports return-to-school and return-to-work programs through serial testing.

  Sam Brusco, Associate Editor 04.01.21
  

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• Diagnostics
  

  Abbott's Rapid COVID-19 Self-Test Receives EUA

  Permits asymptomatic, non-prescription, over-the-counter self-use for people with or without symptoms.

  Sam Brusco, Associate Editor 04.01.21
  

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• Digital Health
  

  Hackers and Home Healthcare Equipment Concerns

  MPO's Sean Fenske continues a discussion with Alan Grau of Sectigo about home and mobile healthcare devices and the threat of hackers.

  Videos Sean Fenske, Editor-in-Chief

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• Neurological
  

  Encora's Tremor Reducing Wristband Gains Breakthrough Status

  Indicated to provide temporary hand tremor relief in adult essential tremor or Parkinson's patients.

  Sam Brusco, Associate Editor 03.31.21
  

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• Cardiovascular | Patient Monitoring
  

  GE Healthcare Reveals Venue Fit POC Ultrasound with Cardiac AI Tool

  AI tool continuously calculates the heart’s real-time ejection fraction.

  Sam Brusco, Associate Editor 03.31.21
  

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• Diagnostics
  

  Diagnosing the IVD Market: An Interview with TEAM Technologies

  Chief revenue officer Steve Lents discusses the in-vitro diagnostic market and manufacturing rapid antigen POC COVID-19 tests.

  Online Exclusives Sam Brusco, Associate Editor 03.30.21
  

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• 

  Jabil Healthcare, E3D Collaborate on Drug Delivery Device Tech

  Agreement provides Jabil with exclusive license to develop drug delivery device product platform based on E3D mechanical multi-use auto-injector technology.

  Michael Barbella, Managing Editor 03.30.21
  

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• Cardiovascular
  

  Heart Failure Treatment Using Electrical Microcurrent Shows Promise

  Berlin Heals' C-MIC device restores endogenous electric potential gradients using microcurrents, leading to improved myocardial function.

  Michael Barbella, Managing Editor 03.30.21
  

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• Diagnostics
  

  BD's Combo COVID-19, Flu Rapid Antigen Test Earns EUA

  Can detect SARS-CoV-2, influenza A, influenza B from a single patient sample in 15 minutes.

  Sam Brusco, Associate Editor 03.30.21
  

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• Digital Health
  

  Philips, Orbita Partner to Create AI Assistants for Patient Engagement

  Conversational voice and chatbot applications will complement Philips' telehealth solutions.

  Sam Brusco, Associate Editor 03.30.21
  

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• Cardiovascular
  

  FDA Breakthrough Status Granted to Cook Medical's Zenith Endovascular Graft

  ZFEN+ includes up to five precisely located fenestrations to accommodate the visceral vessels.

  Michael Barbella, Managing Editor 03.29.21
  

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• Cardiovascular
  

  FDA Approves Medtronic's Harmony TPV for Congenital Heart Disease

  Less invasive option to treat pulmonary valve regurgitation for patients with a native or surgically-repaired right ventricular outflow tract.

  Sam Brusco, Associate Editor 03.26.21
  

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• Digital Health
  

  NuroKor Teams Up With Medi-Launch Partners to Develop Wearable Pain Tech

  U.K. bioelectronics company sets its sights on the U.S. market following a series of new investors, new product developments and a 156 percent sales surge.

  Michael Barbella, Managing Editor 03.26.21
  

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