by
Sean Ruck, Contributing Editor | March 22, 2013
From the March 2013 issue of HealthCare Business News magazine
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ENSEAL G2 Articulating Tissue Sealer
To address surgeons’ need for strong sealing in tight spaces where access is limited, Ethicon Endo-Surgery, Inc. recently announced the 510(k) clearance from the U.S. Food and Drug Administration for the ENSEAL G2 Articulating Tissue Sealer. ENSEAL G2 Articulating is the first articulating advanced energy device designed to allow surgeons to take a perpendicular approach to seal vessels up to 7mm in diameter and lymphatics through a 5mm port.
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ergo Imaging System nuclear medicine camera
Digirad Corporation recently announced that it received U.S. FDA 510(k) market clearance to expand the clinical applications for their system. The additional clearance includes indications for lymphatic scintigraphy and parathyroid scintigraphy, both nuclear diagnostic imaging tests that aid in the evaluation of lesions in the breast and other small body parts. The system features a large field of view solid-state detector. Five collimator options provide the capability to provide outstanding imaging quality for a wide range of procedures with energy ranges from 50 to 350 keV. The open gantry, long 48” reach and multiple compound motions provide enhanced positional flexibility to address various applications and patient settings. Lightweight and portable, it can be easily moved throughout the hospital maximizing the system’s utility and convenience.
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EDGE radiosurgery system
The U.S. Food and Drug Administration has granted Varian Medical Systems clearance for a new radiosurgery system that the company said will improve tumor tracking and motion management when delivering high doses of radiation to patients during treatment. The new EDGE radiosurgery suite includes five technologies: a flexible treatment couch to position patients optimally; a real-time imaging package that also includes expanded use of fluoroscopy and 4D cone-beam CT; an integrated intracranial radiosurgery package; and several enhancements to Varian’s real-time tracking system Calypso. The Calypso anchored Beacon transponder for implantation — or position signaling device to track motion during treatment in the lung — is still pending 510(k).
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