Regulatory
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Intertek, Globizz Partner to Offer Regulatory Services to Device Manufacturers
Collaboration will provide regulatory consulting, technical services, and strategic planning for medical device manufacturers in Japan and the United States.Business Wire 09.17.21
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FDA Premarket Approval Granted for Neuro Cochlear Implant System
Oticon Medical's product is designed to treat severe to profound sensorineural hearing loss.Business Wire 09.15.21
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Vertigo Treatment Receives FDA Breakthrough Device Designation
The device's developer—Otolith Labs—closes $3.3 million in seed financing.Business Wire 09.13.21
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The New U.K. Conformity Assessment: 10 Checklist Items
The transition to the U.K.’s new regulatory regime officially began as of the first of January 2021.Ed Ball, Senior Associate, RQM+ 09.10.21
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AI-Based Medical Devices: The Regulatory Landscape
Artificial intelligence/machine learning (AI/ML) has wide-ranging applications within the healthcare industry.Danielle Besal, MS, Principal Consultant, MRC Global LLC 09.10.21
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Software & IT
Better Claims Management Starts at the Source
Claims management is an essential part of commercializing a product and getting it to patients.Terri Howard, Director, Commercial and Medical Strategy, Veeva MedTech 09.10.21
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Three Systems of Risk—Mike on Medtech
Mike Drues and Sean Fenske highlight the three systems of risk within the medical device manufacturing regulatory landscape and discuss the purpose of each.Sean Fenske, Editor-in-Chief 09.07.21
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CE Mark Granted to Expandable, Biodegradable Biliary Stent
The UNITY-B Percutaneous Balloon Expandable Biodegradable Biliary Stent is intended to facilitate the drainage of obstructed ducts requiring larger openings.PR Newswire 09.07.21
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AI-Powered Stroke Guidewire Granted Breakthrough Device Status
The Clotild Smart Guidewire System from Sensome provides physicians with critical information on a blood clot.Business Wire 09.07.21
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iCAD Wins CE Mark for Latest Generation of 3D Mammography Solution
ProFound AI Version 3.0 offers considerable improvement in algorithm specificity performance and faster processing compared to previous generations.Globe Newswire 08.27.21
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Glaukos' PRESERFLO MicroShunt Approved in Australia
Product is an ab-externo, drainage system that helps drain eye fluid and reduces IOP in patients with primary open-angle glaucoma.Business Wire 08.19.21
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Health Canada Approves Butterfly iQ+ Platform
The second-generation handheld device is now available in 20 countries worldwide.Business Wire 08.13.21
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Diagnostics
Regulating IVDs and LDTs—Mike on Medtech
Mike Drues and Sean Fenske discuss proposed regulations around in vitro diagnostics and lab-developed tests.Sean Fenske, Editor-in-Chief 08.10.21
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How to Become ISO 13485 Certified
Complying to ensure lifelong quality of medical devices and gain access to certain medical device markets.Online Exclusives Emily Drinks, Digital Content Consultant with WebFX 08.05.21
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Breakthrough Device Designation Granted for Cluster Headache Treatment Tech
Unity HA's localized treatment is free from drug-related side effects.Unity HA 08.02.21
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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
