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  Increased Wear Time Permitted for Guard Medical's Surgical Dressing

  The FDA okayed NPseal's wear time extension to six days.

  Business Wire 07.28.21
  

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• Diagnostics
  

  Breakthrough Device Designation Granted for Skin Cancer Diagnostic

  Veriskin also secures funding from the National Cancer Institute for its TruScore device.

  Business Wire 07.28.21
  

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• Packaging & Sterilization
  

  Facility Falsified Sterilization Data—Mike on Medtech

  Mike Drues and Sean Fenske discuss troubling concerns over a sterilization provider in Italy.

  Sean Fenske, Editor-in-Chief 07.27.21
  

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  Axonics Receives FDA Approval to Expand MRI Labeling

  Expansion allows the use of detachable extremity coils for patients undergoing 1.5T and 3.0T MRI scans.

  Business Wire 07.26.21
  

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  Tasso-M20 Device Earns CE Mark Certification

  Device is being used across multiple virtual clinical trials to gather unprecedented amounts of pharmacokinetic data.

  Business Wire 07.23.21
  

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  Digitization of the Regulatory Review

  The FDA’s roadmap to digitization and remote audits includes more modernized approaches to regulatory oversight.

  Sara Bresee and Matt Lowe, MasterControl 07.22.21
  

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• Testing
  

  Guidance on Skin Irritation With a Push to Achieve the 3 Rs

  The publication of ISO 10993-23:2021 marks a paradigm shift in prioritizing in-vitro testing alternatives within the medical device biocompatibility space.

  Nick Hibbard, In-Vitro Scientific Research Fellow at WuXi AppTec Medical Device Testing 07.22.21
  

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  CE Mark Granted for Axonics' Implantable Sacral Neurostimulator

  The FDA approved the device last year.

  Business Wire 07.21.21
  

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  Aspen Laser Granted New U.S. Patent for Laser Therapy Device

  Company expanded and relocated its corporate headquarters in Utah earlier this year.

  PR Newswire 07.16.21
  

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  4 Critical Considerations for Medical Devices in a Post-Brexit UK

  Brexit impacted multiple industries, and the medical device industry was not spared.

  Online Exclusives Bruce McGill, Vice President of Global Certification, Intertek 07.15.21
  

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• 

  RQM+ Launches Free IVDR Search Tool

  Allows users to navigate IVDR legislation using subject areas most likely to be relevant to their day-to-day work.

  RQM+ 07.09.21
  

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• 

  Santen Granted Health Canada Approval of PRESERFLO MicroShunt

  The product is currently available in Europe.

  Business Wire 07.07.21
  

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  EU MDR Preparedness: How Is COVID-19 a Factor?

  Properly plan ahead so that your company can tackle regulatory hurdles without any struggles.

  Online Exclusives Jon Speer, Founder of Greenlight Guru 07.06.21
  

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• Surgical
  

  FDA Clears Standard Bariatrics' Stapling Technology for Sleeve Gastrectomy

  The Titan SGS design ensures more consistent staple formation across the entire 23-centimeter cutline.

  PR Newswire 07.02.21
  

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• Digital Health
  

  EXINI Diagnostics Receives CE Mark Clearance for aPROMISE

  The technology allows healthcare professionals and researchers to perform quantitative assessment of prostate-specific membrane antigen.

  Business Wire 07.02.21
  

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• 

  NORBIT Achieves ISO 13485 Certification

  The certification allows the Norwegian electronics supplier to service the medical industry.

  NORBIT 06.30.21
  

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• Cardiovascular
  

  CE Mark Granted to Phoenix Cardiac's BACE Device

  Product is designed to address the root cause of mitral regurgitation, avoiding the need for open-heart surgery.

  Phoenix Cardiac Devices 06.30.21
  

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• 

  FDA Grants IDE Approval for Sommetrics Sleep Apnea Trial

  Study will be conducted at 10 sites located in Arizona, Florida, Ohio, Pennsylvania, and South Carolina.

  Business Wire 06.30.21
  

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  TÜV SÜD North America Gains FDA Accreditation for Device Testing

  TÜV SÜD offers ASCA-accredited laboratory testing of medical devices at five U.S. locations and in Canada.

  Business Wire 06.29.21
  

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• Surgical
  

  FDA Clears Wire-Free Localization Tech for Breast Cancer Surgery

  The new device helps surgeons remove lesions more efficiently with accuracy and specificity.

  PR Newswire 06.25.21
  

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  FDA Breakthrough Status Granted for Implandata's EYEMATE System

  Product is the world’s only clinically-validated product used for comprehensive remote glaucoma monitoring.

  B3C Newswire 06.25.21
  

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  Establishment Labs Completes Breast Enhancement Study Enrollment

  Company also announces CE Mark filing of tools for Motiva Mia System.

  Business Wire 06.24.21
  

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  FDA Breakthrough Device Designation Granted for Revita DMR

  Study is underway to evaluate the effectiveness of Revita DMR in improving glucose control while reducing or eliminating the need for insulin.

  Business Wire 06.24.21
  

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  Canada Approves Drug-Releasing Contact Lens for Eye Allergies

  Daily disposable lens corrects vision and provides relief to patients suffering from allergic conjunctivitis.

  PR Newswire 06.23.21
  

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  FDA Clears Soundbite Medical's Recanalization Tool

  Product consists of the reusable SoundBite Console, a single-use sterile SoundBite Active Wire 14P, and their respective accessories.

  Business Wire 06.22.21
  

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  Health Canada Clearance Granted to Ambu's Single-Use Flexible Cystoscope

  Product is used with the company’s aView 2 Advance, a high-definition display for video endoscopy.

  Business Wire 06.22.21
  

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  CE Mark Granted for Biostable Science's HAART 200 Device

  More than 1,000 patients now treated worldwide with the HAART Aortic Annuloplasty product.

  Business Wire 06.18.21
  

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  Aptar CSP Technologies Earns ISO 13485 Certification

  Recognition comes as the company prepares to commercialize a new medical device using its proprietary 3-Phase Activ-Polymer platform technology.

  Aptar CSP Technologies 06.14.21
  

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  CE Mark Granted for Contego Medical's Next-Gen Carotid Stent

  Clinical trial results show a 100 percent success rate for the product.

  PR Newswire 06.10.21
  

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  Top 483s of 2020—Mike on Medtech

  Mike Drues and Sean Fenske discuss the issues medical device manufacturers had during inspections last year.

  Sean Fenske, Editor-in-Chief 06.08.21
  

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  Intertek Granted ASCA Recognition by FDA for Medical Device Premarket Testing

  he ASCA Pilot Program is a voluntary program developed to provide increased confidence in testing results.

  Michael Barbella, Managing Editor 06.04.21
  

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• Packaging & Sterilization
  

  Packaging Design Considerations to Ensure a Safe, Sterile Medical Device

  Choosing the right packaging configuration for a medical device is critical to ensure safety and sterility to the end user.

  Britt Jones, Manager, Chemistry & Package Testing, WuXi AppTec Medical Device Testing 06.02.21
  

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• 

  FDA Clears Masimo's Radius PCG for the Root Patient Monitoring Platform

  Radius PCG with Bluetooth connectivity seamlessly integrates tetherless mainstream capnography with Root.

  Michael Barbella, Managing Editor 06.02.21
  

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• Digital Health
  

  FDA OKs First AI-Enabled Device for Colon Cancer Detection

  Product is composed of hardware and software designed to highlight portions of the colon where the device detects a potential lesion.

  Michael Barbella, Managing Editor 06.01.21
  

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  Chemence Medical Receives FDA Approval for Exofin Fusion Redesign

  Product line now features mesh that has curved ends.

  Michael Barbella, Managing Editor 05.25.21
  

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  FDA Grants Marketing Clearance to Helius Medical's PoNS Device

  First tongue-delivered neuromodulation therapy provides new treatment option for patients living with gait deficit due to multiple sclerosis symptoms.

  Michael Barbella, Managing Editor 05.24.21
  

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  MedStar Health Joins NESTcc Research Network

  Partnership with largest health provider in U.S. capital region expands NESTcc research expertise, data capabilities for medical device evaluation.

  Michael Barbella, Managing Editor 05.21.21
  

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  nanoComposix Achieves ISO13485:2016 Certification

  Company recently expanded its manufacturing capability for large-scale production of 40 nm gold nanoparticles.

  Michael Barbella, Managing Editor 05.20.21
  

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  CE Mark Granted for Acutus Medical's EP Product Suite

  Greenlighted technologies are designed to streamline procedural workflow in all left heart procedures.

  Michael Barbella, Managing Editor 05.19.21
  

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  FDA Clears Nanox's Single-Source Digital X-Ray

  Company's technology digitally generates electrons and successfully replaces the thermionic filament ‎in the X-ray tube.

  Michael Barbella, Managing Editor 05.17.21
  

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  FDA Grants Breakthrough Device Status to Epilepsy Treatment System

  NeuroPace's RNS System is currently available in the United States as an adjunctive therapy for adults with drug-resistant focal epilepsy.

  Michael Barbella, Managing Editor 05.12.21
  

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• 

  Alvalux Medical Awarded Patent for Wearable Dermal Repair System

  Product helps improve old and prevent new hypertrophic and keloid scar healing.

  Michael Barbella, Managing Editor 05.11.21
  

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• 

  Conducting Remote GxP Audits: Three Keys to Success

  While remote audits have always been an option, the pandemic forced quality units to take a fresh look at how to use them effectively.

  Online Exclusives Paula Pilecki, Sr. Director of Project and Audit Management, MWA Consulting Inc. 05.07.21
  

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  FDA Approves Helius Medical's Stimulator Device for Gait Improvement

  The product is a short-term treatment for gait deficit as a result of mild to moderate symptoms from multiple sclerosis.

  Michael Barbella, Managing Editor 05.06.21
  

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• 

  Embedding Risk-Based Thinking into Quality Efforts

  Controlling risk is an important requirement for companies developing regulated products.

  Online Exclusives David Jensen, Staff Writer, Master Control 05.04.21
  

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• Surgical
  

  FDA Clears XPERIENCE No Rinse Antimicrobial Solution

  The solution defends against germs for hours and can used in virtually every open surgery case.

  Michael Barbella, Managing Editor 05.04.21
  

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• 

  Breakthrough Device Designation Granted to Tempus’ Afib ECG Analysis Platform

  The platform was developed in collaboration with Geisinger.

  Michael Barbella, Managing Editor 05.03.21
  

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  Video & Analytics: Differentiators in a Compliance-Adherent Crowd

  Instead of checking the box with minimal investment in compliance, the firm that elevates its manufacturing practices beyond cGMP will gain more market share.

  Prasad Akella, Founder/CEO, Drishti 05.03.21
  

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  Ensuring Regulatory Compliance for Medical Device Manufacturing

  EMS providers have highly experienced quality teams that intimately understand the regulatory landscape for developing safe and effective medical devices.

  Tim McGinnis, Vice President, Medical Quality and Regulatory Affairs, Sanmina 05.03.21
  

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  Japanese Approval Granted for Shape Memory's IMPEDE-FX Embolization Plug

  The product is indicated for use in Japan as an adjunct to devices such as stents, coils, and plugs.

  Michael Barbella, Managing Editor 04.30.21
  

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