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Biomerix Corp.

Intuitive adds to the da Vinci surgical system arsenal | Regulatory Roundup

January 5, 2012 By MassDevice staff Leave a Comment

Mela

Intuitive Surgical (NSDQ:ISRG) won FDA clearance for its EndoWrist vessel sealer designed for use with the company’s da Vinci surgical robot.

The Sunnyvale, Calif.-based med-tech maker’s device is wristed to give clinicians full control over vessel sealing in vessels up to 7mm.

Filed Under: News Well, Surgical Tagged With: Biomerix Corp., Elron Electronic Industries, Intuitive Surgical, NinePoint Medical Inc., Regulatory Roundup

InfraReDx wins CE Mark approval for coronary imaging system | Regulatory roundup

April 21, 2011 By MassDevice staff Leave a Comment

InfraReDx

InfraReDx Inc. added the European Union to its market for the LipiScan IVUS coronary imaging system.

The Burlington, Mass.-based company won CE Mark approval for the device, which employs both so-called "near-infrared" (NIR) spectroscopy and intravascular ultrasound (IVUS) technology to give cardiologists a grayscale image of a coronary artery, along with a map of lipid core coronary plaques within a blood vessel.

Filed Under: 510(k), Food & Drug Administration (FDA), News Well Tagged With: Biomerix Corp., Hologic, InfraReDx Inc., Orthocon Inc.

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