Arthrocare gets FDA nod for shoulder suture system | Regulatory Roundup

ArthroCare Corp. (NSDQ:ATRC) landed FDA clearance for its SpeedFix suture system for repairing tears in the shoulder joint, a common injury.

The sutures tout independent bone locking, suture tensioning and suture locking to fasten tissue to bone using double-loaded proprietary MagnumWire sutures.

The company won FDA clearance for their SpeedFix anchor system in November 2010.

The clearance is good news for the Austin, Texas-based company, which as been mired in a fraud scandal that took down a former CEO and resulted in multi-million settlements for VPs charged with artificially inflating the company’s stock prices for two years.

FDA panel unanimously okays Berlin Heart pediatric coronary assist device
A specially convened FDA panel unanimously recommended approval of Berlin Heart GmbH’s Excor pediatric ventricular assist device. The panel reviewed data from clinical trials across 15 U.S. centers and concluded that the device meets requirements for Humanitarian Device Exemption approval.

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Caliper lands European CE Mark for diagnostic LabChip
Caliper Life Sciences Inc. (NSDQ:CALP) touted European CE Mark approval for its LabChip Dx clinical diagnostic device based on microfluidics technology. The Hopkinton, Mass.-based company’s device will be sold under the In Vitro Diagnostic Medical Devices directive.
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