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Charter Medical

Toshiba lands 510(k) for latest Aquilon CT scanner | Regulatory Roundup

February 1, 2012 By MassDevice staff Leave a Comment

Toshiba

Toshiba’s (TYO:6502) American medical products division won 510(k) clearance from the FDA for the latest iteration in its Aquilon line of CT scanners.

The Aquilon Prime is designed for healthcare facilities that need to perform a wide variety of advanced clinical examinations with reduced radiation exposure, according to a press release.

Filed Under: 510(k), News Well Tagged With: Avedro Inc., Bovie Medical Corp., CardioKinetix Inc., Charter Medical, Custom Spine, Regulatory Roundup, TearScience, Toshiba, Yolo Medical

Medtronic lands FDA clearance, plans launch for next-gen CRM lead | Regulatory Roundup

January 30, 2012 By MassDevice staff Leave a Comment

Medtronic logo

Medtronic Inc. (NYSE:MDT) landed FDA clearance for its DF4 high-voltage right ventricular lead for use with implantable cardiac rhythm management devices.

The DF4, which builds on Medtronic’s Sprint Quattro lead, aims to help simplify the implantation process with a redesigned port and by providing visual confirmation of the lead’s connection to the device.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Applied Spectral Imaging, Baxano Surgical, Baxter, Cardiac Rhythm Management, CardioKinetix Inc., Charter Medical, Covidien, Cynosure Inc., Positron Corp., Systagenix Wound Management Inc., VuComp Inc.

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