- Accuray wins 510(k) for CyberKnife lung cancer treatment
Accuray Inc. (NSDQ:ARAY) announced that the Food & Drug Administration granted the company 510(k) clearance to market Lung Optimized Treatment, a new component of the CyberKnife VSI system. The 510(k) clearance enables Accuray to provide physicians with greater flexibility in delivering radiosurgery treatments to patients with lung cancer, the most common and deadly cancer worldwide.
- Clear Catheter Systems wins FDA clearance for PleuraFlow
Clear Catheter Systems Inc. of Bend, Ore., announced that it received Food & Drug Administration clearance for its innovative PleuraFlow active tube clearance system. The company has approval to market the device in Europe and Canada, and this regulatory approval clears the way to market the product in the U.S. for patients recovering from cardiothoracic surgery.
- FDA to review Lantheus Medical Imaging’s Definity supplemental new drug application
Lantheus Medical Imaging Inc. announced that the Food & Drug Administration accepted for review the company’s supplemental new drug application for Definity, an injectable suspension for use in stress echocardiography. Definity is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. With this acceptance, the FDA will now review the sNDA to determine whether or not to broaden the FDA-approved indication to include its use with exercise and pharmacologic stress testing.
- Fenwal wins FDA clearance for wireless data export to blood-collection system
Fenwal Inc. announced that the Food & Drug Administration granted 510(k) clearance to for its Alyx component collection system with new wireless data export capabilities.
- EDAP wins South Korean FDA approval for Sonolith i-move lithotripter
EDAP TMS SA (NSDQ:EDAP) reported the approval of its new lithotripter Sonolith i-move by the South Korean Food and Drug Administration.
- EU gives iTech Medical CE Marking for muscle pattern recognition system
iTech Medical Inc. (OTC:IMSU) announced that it received CE Mark approval for its muscle pattern recognition system in the European Union.
- Miracor wins CE-mark for Pisco impulse system
Miracor Medical Systems GmbH announced that it received CE Mark approval for the Pisco pressure-controlled intermittent coronary sinus occlusion impulse system for acute coronary syndrome revascularization after percutaneous coronary intervention.
- BioCer Entwicklungs wins CE Mark for plant-based hemostat
BioCer Entwicklungs GmbH, a Bayreuth, Germany-based medical device manufacturer, announced CE Mark approval for the HaemoCer absorbable polysaccharide hemostat.
- Curvus wins 510(k) Clearance for wireless arrhythmia monitoring device
AS subsidiary Curvus Inc. announced that it received 510(k) clearance
from the Food & Drug Administration for its Curvus arrhythmia monitoring device.
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