Regulatory
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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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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
