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  FDA Breakthrough Device Designation Awarded to BrainCool AB's Cooral System

  The Cooral System was CE marked in June 2020 as an invasive medical device.

  Michael Barbella, Managing Editor 03.02.21
  

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  Medtech Matters: FDA’s Ambiguity on Hyaluronic Acid

  MPO's Sean Fenske speaks with Mike Daley of OrthogenRx about the role HA plays in alleviating knee pain and the challenges with the FDA over it.

  Sean Fenske, Editor-in-Chief 03.02.21
  

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• Cardiovascular
  

  Soundbite Medical Wins Health Canada Approval for PAD Treatment

  Product targets patients with heavily calcified chronic total occlusions.

  Michael Barbella, Managing Editor 03.02.21
  

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  Mike on Medtech: Update on FDA's STeP Designation

  Mike Drues and Sean Fenske discuss the final guidance for the FDA’s STeP designation and who should use it.

  Sean Fenske, Editor-in-Chief 02.26.21
  

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  FDA Clears Ava Fertility Tracking Wearable Device

  The wearable is clinically proven as effective as LH tests in predicting ovulation—and with more fertile days detected.

  Michael Barbella, Managing Editor 02.26.21
  

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  First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

  The product received CE Mark approval in January.

  Michael Barbella, Managing Editor 02.26.21
  

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• Cardiovascular
  

  FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

  Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.

  Michael Barbella, Managing Editor 02.25.21
  

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  FDA Approves Daytime Treatment for Sleep Apnea and Snoring

  Signifier Medical’s proprietary therapy eXciteOSA is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology approved in the U.S.

  Michael Barbella, Managing Editor 02.23.21
  

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  Navient Receives Chinese Regulatory Clearance for ENT Applications

  The surgical navigation system is already approved in the United States, Europe, Canada, South Korea, Brazil, and Taiwan.

  Michael Barbella, Managing Editor 02.22.21
  

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  FDA Clears B-Secur's HeartKey EKG/ECG Technology

  The product's algorithms can be quickly integrated in semiconductors for devices in the medtech, health monitoring, and wellness sectors.

  Michael Barbella, Managing Editor 02.19.21
  

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  FDA Appoints its First Cybersecurity Director

  University of Michigan associate professor to serve a one-year term within the Center for Devices and Radiological Health.

  Michael Barbella, Managing Editor 02.17.21
  

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  FDA Clears Pulse Biosciences' CellFX System

  The product delivers Nano-Pulse Stimulation technology in dermatologic procedures.

  Michael Barbella, Managing Editor 02.17.21
  

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  FDA Clears Rapid Acoustic Pulse Technology for Use in Cellulite

  The RAP device induces mechanical disruption in fibrous structures, such as the septae contributing to dimples in cellulite.

  Michael Barbella, Managing Editor 02.10.21
  

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• Cardiovascular
  

  FDA Clears Wearable Electrocardiogram Sensor

  The product offers extended ambulatory ECG recording up to three weeks.

  Michael Barbella, Managing Editor 02.08.21
  

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• 

  Tips for Reigniting Your MDR/IVDR Preparation

  To get the MDR/IVDR preparation ball rolling again, here are four processes to help refocus on achieving compliance with the updated regulations.

  Nicolle Cannon, Founder and CEO, Cannon Quality Group LLC 02.03.21
  

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  How to Better Prepare for Regulatory Requests and Minimize Impact

  Pressure to increase efficiency in medical device development has been prevalent over the past year, especially with the intensified regulatory expectations.

  Sandi Schaible, Sherry Parker and Kim Ehman, WuXi AppTec Medical Device Testing 02.03.21
  

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  Pulse Biosciences Granted CE Mark Approval for CellFX System

  Product delivers nano-pulse stimulation technology to clear hard-to-treat benign skin lesions.

  Michael Barbella, Managing Editor 02.03.21
  

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  Stericycle Settles Environmental Violations at Its Medical Waste Incinerator

  Agreement includes Supplemental Environmental Project to provide low-emitting school buses to local school district.

  Michael Barbella, Managing Editor 02.01.21
  

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  FDA Clears 3D Acellular Dermal Matrix

  The technology is supported by more than 150 peer-reviewed published articles.

  Michael Barbella, Managing Editor 01.27.21
  

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  FDA Clears a Portable Hemodialysis System

  Quanta Dialysis Technologies' SC+ system became available in the U.K. last year.

  Michael Barbella, Managing Editor 01.26.21
  

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  Mike on Medtech: Emergency Use Authorizations

  Mike Drues and Sean Fenske discuss what happens when the pandemic ends and what companies with EAUs need to do.

  Sean Fenske, Editor-in-Chief 01.26.21
  

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• 

  AtriCure Receives FDA Clearance to Expand its Labeling for Cryo Nerve Block Therapy

  The expansion includes adolescent patients who can benefit from cryo nerve block therapy during surgical procedures involving the chest wall.

  Business Wire 01.20.21
  

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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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  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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  SCONE Medical Awarded Emergency FDA Authorization for Self-Contained Negative Pressure Environment

  Product evacuates contagious aerosols from the environment surrounding a patient during aerosol-generating procedures.

  Videos PR Newswire

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  FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

  New software version for Vantage Orian 1.5T also offers a solution to help clinicians image and quantify fatty liver disease.

  Business Wire 01.15.21
  

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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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• 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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• 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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• 

  TransEnterix's Senhance Surgical System Approved in Russia

  The Senhance System is designed to maintain laparoscopic minimally invasive surgery standards while providing digital benefits.

  Business Wire 01.12.21
  

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• 

  Anitoa Granted CE Mark for its Maverick Series Portable qPCR Instruments

  The company has previously demonstrated Maverick technology in detecting several types of pathogen DNA and RNA strands.

  PR Newswire 01.11.21
  

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  Exero Medical’s Smart Sensor Granted FDA Breakthrough Designation

  The product provides data on internal tissue healing in the gastrointestinal tract.

  Exero Medical 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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• 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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  Mike on Medtech: CDRH 2021 Priorities

  Mike Drues and Sean Fenske discuss several of the priorities the agency has been talking about recently and why they are important.

  Sean Fenske, Editor-in-Chief 01.08.21
  

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  Caretaker Medical Receives Canadian Approval for Wireless Patient Monitor

  The device measures continuous, uninterrupted blood pressure, heart rate, respiration rate, SpO2, and other vital signs.

  PR Newswire 01.04.21
  

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  New Home Use Indication Granted for the Passio Pump Drainage System

  Product is designed for the drainage of recurrent and symptomatic pleural effusion.

  PR Newswire 12.15.20
  

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  Mike on Medtech: Communicating with the FDA

  Mike Drues and Sean Fenske discuss methods of communicating with the agency and share best practices for doing so.

  Sean Fenske, Editor-in-Chief 12.15.20
  

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  Preparing Your Design Controls for FDA Approval

  Design controls are a set of procedures to build into medical device design and development.

  Online Exclusives Adam Freeman, Freelance Medical Device and Combination Product Design Specialist, Kolabtree 12.09.20
  

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  Sofwave Medical Granted CE Mark for Skin Tightening, Wrinkle Reduction Device

  Company's device also received regulatory approval from the Medical Device Division of the Israeli Ministry of Health.

  PR Newswire 12.09.20
  

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  Survey Finds On-Site Inspections Plummeted by 93 Percent

  Findings from Greenlight Guru survey reveal internal divides within organizations are making medical device companies less competitive.

  Greenlight Guru 12.08.20
  

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  Shimmer Research Receives CE Certification for Inertial Measurement Unit Sensor

  The wearable sensor is now recognized as a medical device in Europe, capable of providing continuous, medical-grade measurements of a person’s activity.

  Shimmer Research 12.07.20
  

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• Diagnostics
  

  FDA Clears AI-Powered Full Field Peripheral Blood Smear Application

  Israel-based Scopio Labs' solution is tailored to augment hematology diagnostics.

  Scopio Labs 12.02.20
  

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  CARMAT Obtains Approval to Resume PIVOTAL Study Implants in France

  Thirteen total implants have been performed thus far within the PIVOTAL study framework.

  CARMAT 12.01.20
  

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  First National Pediatric Cardiac Screening Database is Established

  FDA, industry, and patient advocacy groups join effort to advance effective cardiac screening.

  Business Wire 11.30.20
  

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  FDA Ruling Expands Patient Access to Video Capsule System

  Patients now have access to a mechanism for evaluating the small intestine without in-person interactions with clinicians.

  PR Newswire 11.30.20
  

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  Propel Launches Integrated QMS, PLM, and Regulatory Solution for Device Industry

  The platform includes new capabilities related to electronic instructions for use and global product registration.

  Propel 11.24.20
  

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  Reducing Exposure During Customer Audits

  Two audit streamlining methods are highlighted to help suppliers reduce exposure from outside visitors associated with customer audits.

  Online Exclusives Nicolle Cannon, Founder/CEO, Cannon Quality Group 11.23.20
  

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  Reflow Medical Receives Japanese Approval for the Wingman CTO Catheter

  The Wingman Catheter crosses peripheral CTOs using an extendable beveled tip.

  Business Wire 11.18.20
  

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  FDA Agrees to Participate in MDIC's Collaborative Community Initiative

  Effort is designed to help advance medical device quality and safety to achieve better patient outcomes.

  Business Wire 11.17.20
  

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