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• Tubing & Extrusion
  

  PPE Moves into New Manufacturing Facility

  New building is twice the size of the old one.

  Charles Sternberg, Assistant Editor 01.21.21
  

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• Diagnostics
  

  FDA OKs Canon Medical's AI-Powered, 90cm Bore CT

  Company claims the Aquilion Exceed LB CT offers the industry's largest bore opening.

  Sam Brusco, Associate Editor 01.21.21
  

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• Molding
  

  Freudenberg Medical Expands Injection Molding Operations

  Adds new machines at its Baldwin Park, California facility.

  Freudenberg Medical 01.21.21
  

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• Cardiovascular
  

  First Heart Failure Patient Treated With Impulse Dynamics' CCM Therapy in Brazil

  The Optimizer delivers cardiac contractility modulation therapy, the company’s proprietary technology, to the heart.

  Business Wire 01.21.21
  

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• Cardiovascular
  

  Boston Scientific to Acquire Preventice for Up to $925M

  Acquisition of external cardiac monitoring technologies, services provider to expand rhythm management diagnostics portfolio.

  PR Newswire 01.21.21
  

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• Materials
  

  Researchers Successfully ‘Fine Tune’ New Thermoplastic Biomaterial

  Enables both the rate at which it degrades in the body and its mechanical properties to be controlled independently.

  University of Birmingham 01.20.21
  

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• Diagnostics
  

  RSIP Vision Announces Versatile Medical Image Segmentation Tool

  Delivers efficient anatomical measurements and better treatment options.

  RSIP Visions 01.20.21
  

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• Cardiovascular | Surgical
  

  Haemonetics to Acquire Cardiva for Up to $510M

  Enhances penetration into the large and growing interventional cardiology and electrophysiology markets.

  PR Newswire 01.20.21
  

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• Cardiovascular | Surgical
  

  Abbott Wins Expanded Medicare Coverage for MitraClip

  Includes patients with secondary (or functional) mitral regurgitation resulting from heart failure.

  Abbott Laboratories 01.20.21
  

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• Diagnostics
  

  Thermo Fisher Buys Mesa Biotech for $450M

  Mesa Biotech developed, commercialized a PCR-based rapid POC testing platform for detecting infectious diseases.

  PR Newswire 01.20.21
  

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• Surgical
  

  Freehand Partners with Imperial Medical Solutions

  Supports the introduction of its surgical robots in India, Sri Lanka, Malaysia and the Caribbean.

  Freehand 01.19.21
  

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• Cardiovascular | Patient Monitoring
  

  Hillrom to Buy Bardy Diagnostics for $375M

  Advances digital health offering with expansion into attractive ambulatory cardiac monitoring segment.

  PR Newswire 01.19.21
  

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• Diagnostics
  

  Owlstone Medical Introduces Breath Biopsy Panel for Respiratory Diseases

  Supports research to distinguish between different types of chronic inflammatory airway diseases.

  Owlstone Medical 01.19.21
  

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• Cardiovascular
  

  Occlutech's Atrial Flow Regulator Earns Breakthrough Status for HF

  First-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients.

  PR Newswire 01.19.21
  

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• Cardiovascular | Diagnostics
  

  FDA OKs MRI for Impulse Dynamics' Optimizer CCM Delivery Systems

  FDA clears potential hurdle for many heart failure patients.

  Business Wire 01.19.21
  

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• Surgical
  

  TransEnterix Wins EU Approval for Robotic Surgical Machine Vision System

  Intelligent Surgical Unit enables augmented intelligence on the Senhance surgical system.

  Business Wire 01.19.21
  

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• Digital Health | Software & IT
  

  Philips Buys Capsule Technologies in $635M Deal

  Capsule offers vendor-neutral Medical Device Information Platform with an SaaS business model.

  GlobeNewswire 01.19.21
  

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• Surgical
  

  Medtech Matters: Surgeons Scrubbing In Virtually

  MPO's Sean Fenske speaks with Dr. Nadine Hachach-Haram of Proximie about her company’s ability to bring surgeons to the table remotely.

  Sean Fenske, Editor-in-Chief 01.19.21
  

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• Cardiovascular
  

  FineHeart Successfully Tests Wireless TET System

  A breakthrough in treating patients with severe heart failure.

  FineHeart 01.18.21
  

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• Cardiovascular
  

  U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

  The use of TAVR over open surgical techniques for replacing an aortic valve has exploded globally in recent years.

  GlobalData 01.15.21
  

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• Neurological
  

  Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

  Next-generation digital therapeutic is designed for the treatment of Alzheimer’s disease.

  Business Wire 01.14.21
  

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• Surgical
  

  Moon Surgical Expands Leadership Team

  Adds Jeffery Alvarez, David Noonan, and Nicolas Linard.

  Moon Surgical 01.14.21
  

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• Diagnostics
  

  Rapid Antigen Tests Manufacturer Acquires BIOLAB

  Deal will create jobs and increase Innova's U.S. COVID-19 test kit manufacturing capability.

  Innova Medical Group Inc. 01.14.21
  

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• Neurological
  

  Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson's

  First-of-its-kind study tests automated therapy that responds to brain signals in Parkinson's patients.

  PR Newswire 01.14.21
  

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• Diagnostics
  

  PerkinElmer's SARS-CoV-2 RT-PCR Assay Earns EUA for Asymptomatic Testing

  Gold-standard testing of individuals without COVID-19 symptoms key to controlling the spread.

  Business Wire 01.14.21
  

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• Diagnostics
  

  High-Volume COVID Antigen Test Receives FDA EUA

  Ortho’s Vitros can run up to 130 tests per hour and helps address testing backlogs, supply shortages, and delayed results.

  Ortho Clinical Diagnostics 01.13.21
  

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• Patient Monitoring
  

  Valencell Launches Blood Pressure Monitoring Tech

  New technology can be built into a myriad of devices to provide accurate blood pressure readings.

  Valencell 01.13.21
  

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• Electronics
  

  Meeting Critical Ventilator Product Requirements Amid Pandemic

  One supplier serves as a case study in how to service OEMs during potentially catastrophic disruptions to the supply chain.

  Online Exclusives Sven Richter, Vice President Analytical & Medical, Fluid Control & Pneumatics, Emerson 01.13.21
  

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• Diagnostics
  

  Researchers Develop Chip That Can Detect COVID-19 Antibodies in a Minute

  New diagnostic platform could be a valuable tool for detecting exposure to multiple viruses.

  Bob Marcotte, University of Rochester 01.13.21
  

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• Cardiovascular
  

  WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

  Company adds to portfolio of 40 patents for catheter-based technology that leverages the power of the body’s natural fluid removal process.

  Business Wire 01.13.21
  

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• Digital Health | Software & IT
  

  FDA Releases Artificial Intelligence, Machine Learning Action Plan

  Outlines FDA’s next steps toward furthering oversight for AI/ML-based "software as a medical device."

  U.S. Food and Drug Administration 01.13.21
  

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• Diagnostics
  

  Abbott to Supply Additional 30M COVID-19 Tests to U.S. Gov't

  Company is in final stages of completing its self-funded capacity expansion across U.S. manufacturing sites.

  PR Newswire 01.13.21
  

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• Chronic Disease | Digital Health | Patient Monitoring
  

  Teladoc Health, Dexcom Launch CGM Tech, Personalized Insights for Type 2 Diabetes

  CGM-powered insights offer complete health profile, recommendations that support ongoing diabetes management.

  GlobeNewswire 01.13.21
  

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• Patient Monitoring
  

  Unique Contact Lens Sensor System & Manufacturing Process Developed

  New multifunctional lens can provide diversified signals from eyes.

  Surrey University 01.12.21
  

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• Surgical
  

  Medtech Matters: Talking Robotic Surgery with Zimmer Biomet

  MPO's Sean Fenske speaks with Liane Teplitsky of Zimmer Biomet about the firm’s efforts in robotic surgery and its Rosa System.

  Sean Fenske, Editor-in-Chief 01.12.21
  

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• Contract Manufacturing
  

  Vonco Products Receives ISO 13485:2016 Certification

  Both a packaging company and a components company, Vonco started as a custom equipment and packaging pioneer.

  Business Wire 01.12.21
  

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• Neurological | Surgical
  

  FDA OKs ClearMind Biomedical's Axonpen Neuroendoscope

  Requires only a narrow channel of 6.5mm through the skull for insertion into the brain.

  PR Newswire 01.12.21
  

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• Patient Monitoring
  

  Itamar Medical Acquires Spry Health Tech, Assets

  Leverages Spry’s technology to bring to market first device for continuous remote patient monitoring of sleep apnea.

  GlobeNewswire 01.12.21
  

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• Packaging & Sterilization
  

  STERIS to Buy Cantel Medical for $4.6B

  Complementary to STERIS’s product and service portfolio, focused on infection prevention.

  GlobeNewswire 01.12.21
  

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• Materials
  

  Momentive Performance Materials Acquires KCC Corp.’s Silicones Business

  Further strengthens its global capabilities in advanced silicones.

  PRNewswire 01.11.21
  

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• Patient Monitoring
  

  CES News: Philips Highlights Healthcare at Home

  Participates in the first-ever all-digital CES 2021.

  Royal Philips 01.11.21
  

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• Diagnostics
  

  Olympus and Hitachi Sign Five-Year Contract

  Will jointly develop Endoscopic Ultrasound Systems.

  Olympus Corporation 01.11.21
  

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• Diagnostics
  

  ForaCare Suisse AG Launches COVID-19 Antigen Rapid Test

  Provides fast, accurate, and easy-to-interpret test results.

  PRNewswire 01.11.21
  

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• Diagnostics | Neurological
  

  FDA OKs Abbott's First-of-Its-Kind Rapid, Handheld TBI Test

  Produces a result within 15 minutes after a plasma sample is inserted.

  Abbott Laboratories 01.11.21
  

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• Diagnostics
  

  SARS-CoV-2 Mutation Prompts FDA Alert

  Impact remains low, but false negative results can occur with any molecular test.

  U.S. Food and Drug Administration 01.11.21
  

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• Diagnostics
  

  CareDx Partners with IDbyDNA

  Will develop AlloID, a transplant patient-specific metagenomic infectious disease test platform.

  Globe Newswire 01.08.21
  

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• Diagnostics
  

  Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA

  Helps identify severe inflammatory immune responses in patients confirmed to have COVID-19.

  Siemens Healthineers 01.08.21
  

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• Cardiovascular
  

  Acutus Medical Launches AcQCross Transseptal System in Europe

  The product is designed to improve safety and efficiency in any procedure requiring left heart access.

  Globe Newswire 01.08.21
  

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• Diagnostics
  

  Quantitative Transmission Ultrasound Outperforms Mammography

  QT Imaging completes first-in-human study of transmission ultrasound as a new imaging technology for breast health screening.

  PRNewswire 01.07.21
  

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• Neurological
  

  BioSerenity Achieves FDA Clearance for Wearable Device System

  Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.

  PRNewswire 01.07.21
  

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