Regulatory
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MagXtract's COVID-19 Testing Collection Tube Cleared in U.S., Europe
The tube It is also validated for bacterial and fungal sample collection as well as stabilization in research studies.Michael Barbella, Managing Editor 10.06.22
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C&M Precision Tech Earns ISO 13485 Certification
Company also holds AS 9100D/ISO 9001 and ISO 9001:2015 certifications.Michael Barbella, Managing Editor 10.04.22
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A Letter to File Deep Dive—Mike on Medtech
Mike Drues and Sean Fenske discuss how a letter to file is to be used, when to use it, and how to avoid problems with FDA.Sean Fenske, Editor-in-Chief 10.04.22
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Why Regulatory Teams Must Establish a Single Source of Truth
Having a single source of truth—a set of data shared across an entire organization—is incredibly important within the life sciences industry.Online Exclusives Laura Jones, Director, Product Management - RIM, ArisGlobal 10.03.22
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Diagnostics
FDA Changes COVID-19 Test Policy to Cut EUA Requests
COVID-19 test manufacturers are encouraged to seek de novo or 510(k) pathways for clearance.Sam Brusco, Associate Editor 09.27.22
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Linamar MedTech Achieves ISO 13485 Certification
Linamar MedTech is the newest division of Linamar Corporation that focuses on contract manufacturing of complex medical device assemblies.Michael Barbella, Managing Editor 09.26.22
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Brain Scientific Awarded CE Mark Approval for NeuroCap Device
NeuroCap enables clinicians to prepare a patient for an EEG exam in a fraction of the time normally spent applying individual electrodes.Michael Barbella, Managing Editor 09.22.22
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Cardiovascular
FDA Approves Thermedical's SERF Ablation Clinical Study
Trial will evaluate the Durablate catheter in treating patients with ventricular arrhythmias who are resistant to antiarrhythmic drugs or standard ablation.Michael Barbella, Managing Editor 09.21.22
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Diagnostics
FDA Clears MedWand's Vital Sensors Device
Company is rolling out its solution through strategic partnerships with major health systems, physician groups, and telehealth firms.Michael Barbella, Managing Editor 09.21.22
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Avenda Health Awarded IDE for AI-Enabled Prostate Cancer Therapy
The exemption enables Avenda's FocalPoint ablation system to be used in a randomized control trial to advance prostate cancer research.Michael Barbella, Managing Editor 09.16.22
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NeuroOne Medical Seeking Special Use for Evo sEEG Electrode
Company's FDA application requests clearance to extend the electrode's use.Michael Barbella, Managing Editor 09.14.22
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FDA Clears Expanded Energy Settings for CellFX System
The expanded settings will provide more customized energy delivery specific to individual lesions.Michael Barbella, Managing Editor 09.09.22
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Elcam Medical Achieves MedAccred Plastics Injection Molding Accreditation
Company is the first Israeli manufacturer to obtain the accreditation.Michael Barbella, Managing Editor 08.31.22
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N95 Respirators Taken off Medical Device Shortage List
Increased domestic manufacturing, supply chain assessment, and new options helped beat the shortage.Sam Brusco, Associate Editor 08.29.22
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AD Ports Logistics Awarded Medical Device ISO Certification
The company is now one of the first service providers in the UAE to be fully accredited for medical device supply chain management services.Michael Barbella, Managing Editor 08.29.22
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New ASTM Standard Unifies Microphysiological Terms
This standard and others like it aims to ease cooperation involving microphysiological system models.Michael Barbella, Managing Editor 08.26.22
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Diagnostics
FDA Clears Radialis PET Imager
The system can produce functional images with high spatial resolution, expanding the insight available from molecular imaging.Michael Barbella, Managing Editor 08.25.22
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ISO 13485 Certification Granted to Techner PM's QMS
Company has been working on gaining this certification since fall 2021.Michael Barbella, Managing Editor 08.25.22
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MultiMedical Systems Earns ISO 13485:2016 Certification
The company provides medical device sales, service, and repair offerings.Michael Barbella, Managing Editor 08.24.22
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FDA Grants IDE Approval for Sleep Apnea Study
First patient expected to be implanted in fourth quarter with a minimally invasive surgical solution to address their OSA.Michael Barbella, Managing Editor 08.22.22
