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  Kwivik Therapeutics, EirMed Partner to Accelerate Product Commercialization

  Kwivik has developed a pipeline of products for certain respiratory, emergency medical, asthma, migraine/cluster headache, wound care, and skin care markets.

  Michael Barbella, Managing Editor 01.27.21
  

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• Cardiovascular | Surgical
  

  Twist on Heart Valve Design Boosts Blood Flow, Prevents Clots

  UBC Okanagan research could transform the current gold standard for heart valves.

  Sam Brusco, Associate Editor 01.27.21
  

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• Diagnostics
  

  Abbott's Panbio Rapid COVID-19 Antigen Test Earns CE Mark for Two New Uses

  EU approves symptomatic screening and self-administered sample collection with nasal swab.

  Sam Brusco, Associate Editor 01.26.21
  

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• Cardiovascular
  

  Alleviant's Transcatheter Tech Obtains Breakthrough Status

  The technology offers a no-implant interatrial shunt therapy for heart failure patients.

  Sam Brusco, Associate Editor 01.25.21
  

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  MedAcuity, Fathom Partner on Human Factors Engineering Services

  Focused on facilitating safe and effective use of medical devices, HFE is a critical aspect of product development.

  Michael Barbella, Managing Editor 01.25.21
  

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  Are you prepared for EUDAMED actor registration module? Let’s get started

  Through this webinar, participants will be able to focus exclusively on “Actor Registration Module” which is key to accessing and using EUDAMED.

  01.22.21
  

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  Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

  Company initiates VFE testing for its porous polymer-based materials; results show components protect against certain aerosolized viruses.

  Michael Barbella, Managing Editor 01.22.21
  

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  Henry Schein Buys Majority Interest in Prism Medical Products

  PRISM will operate as a subsidiary of Henry Schein Medical and will be managed separately as an individual division.

  Michael Barbella, Managing Editor 01.22.21
  

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• Neurological
  

  Boston Scientific's Vercise Genus DBS Earns FDA Approval

  Fourth-generation DBS portfolio features full-body MR conditional devices.

  Sam Brusco, Associate Editor 01.22.21
  

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  Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection

  The new detection method can help determine whether patients have had COVID-19 and if they might still have immunity to the disease.

  Michael Barbella, Managing Editor 01.22.21
  

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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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  Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.

  The daily disposable, silicone hydrogel contact lens for astigmatism will roll out concurrently worldwide beginning in February.

  Sam Brusco, Associate 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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  PhysIQ Elects Former Naval Vice Admiral to its Advisory Board

  New board member most recently Washington State's medical and healthcare systems response to the COVID-19 pandemic.

  Business Wire 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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  Evonik Closes LACTEL Absorbable Polymers Acquisition

  LACTEL's biodegradable, PLGA-based polymers will be integrated into Evonik’s Health Care business.

  Evonik 01.21.21
  

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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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  Intersect ENT Announces CMS Approval of Coding Application for Sinus Implant

  Establishes new S code for Propel to facilitate specific coding and payment.

  Business Wire 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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  Cognoptix Forms a New Board of Directors

  The board is now comprised of a mix of healthcare investors and a leading expert on biomarker discovery.

  PR Newswire 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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  FDA Authorizes Interscope's EndoRotor System for Direct Endoscopic Necrosectomy

  Product allows physicians to simultaneously resect, aspirate necrotic material from a walled-off pancreatic collection under direct endoscopic visualization.

  PR Newswire 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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  Telemedicine, Regulatory Changes to Characterize Medtech Industry in 2021

  The global pandemic has created an urgent need for telemedicine.

  GlobalData 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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  FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor

  Product contains integrated sensor technologies designed to measure patient activity, heart rate, and body temperature.

  PR Newswire 01.14.21
  

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  Surge Period Expected for ERCP and PTC Devices Market

  But the boost will not offset revenue losses due to COVID-19.

  GlobalData 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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  Rhythmlink Acquires Chalgren Enterprises, Expands Product Lines

  Deal will enable Rhythmlink International to now offer products for epilepsy monitoring, electroencephalography, electromyography, and more.

  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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