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Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
Update on FDA 510(k) Submission for the CellFX System in Dermatology: Reported by Pulse Biosciences
We remain highly confident in the CellFX System and its safety and efficacy profile in aesthetic dermatology. We look forward to continuing to work with FDA to obtain a clearance for the CellFX system in dermatology.” said Darrin Uecker, President and CEO of Pulse Biosciences.
Orthofix Announces FDA Approval of STIM onTrack 2.1 Mobile App for Bone Growth Stimulators
The STIM onTrack technology works with the Orthofix Bone Growth Therapy devices. The mobile device app is an accessory designed to help patients adhere to their prescriptions and improve their clinical outcomes.
FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer® Inside-Out® Access Catheter System
The company reports that the Surfacer System will be available in select U.S. centers in the coming months. The system received CE Mark in 2016 and is available in Europe, Canada, Singapore and the Middle East.
FDA Clears LUNGguard for Donor Lung Preservation System
The LUNGguard Donor Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for LUNGguard is up to 8 hours.
Atlantic Therapeutics Announces FDA Clearance for Over-the-Counter Use of INNOVO®
Atlantic Therapeutics reports this approval represents a major milestone that will be a key value driver for Atlantic Therapeutics.
CardioFocus Announces U.S. FDA PMA Supplement Submission For The Breakthrough HeartLight X3 Endoscopic Ablation System
The HeartLight X3 System by CardioFocus is a next-generation AFib ablation technology, building upon the advanced features of the HeartLight Endoscopic Ablation System.
QYNAPSE Novel Imaging Software for Central Nervous System Diseases Receives FDA Clearance
QyScore® allows automated quantification of a broad portfolio of Magnetic Resonance Imaging markers that are key to support early diagnosis and clinical monitoring of neurodegenerative disorders notes QYNAPSE.
