Cardica Receives 510(k) Clearance For MicroCutter XCHANGE™ 30 Cutting/Stapling Device

Cardica, Inc. (CRDC) today announced it obtained 510(k) clearance of the MicroCutter XCHANGE™ 30 device and blue staple cartridge for medium thickness tissue from the U.S. Food and Drug Administration for use in multiple open or minimally-invasive surgical procedures for the transection, resection and/or creation of anastomoses in small and large intestine, as well as the transection of the appendix. The XCHANGE 30 is the smallest diameter cutting and stapling device available today, with articulation up to 80 degrees and single-handed operation.

Published: 09 January 2014
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Stereotaxis Completes Clinical Trial of Vdrive(TM) With V-Loop(TM) System

Stereotaxis, Inc. (STXS) announced today that it has completed the clinical trial required for FDA clearance of the Company's Vdrive(TM) Robotic Navigation System with V-Loop(TM) Circular Catheter Manipulator. Results of the 120-patient study, which was conducted at three Stereotaxis sites in the U.S. and two in Europe, will be included in a 510(k) Premarket Notification the Company intends to submit in the first quarter of 2014.

If cleared by the FDA, the Vdrive with V-Loop system will be the Company's second Vdrive product to be cleared for use in the U.S. Its Vdrive with V-Sono(TM) Intracardiac Echocardiography Catheter Manipulator received FDA clearance in July 2013 and has been utilized in more than 50 cardiac ablation procedures to date in the U.S.

Published: 07 January 2014
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Electromed, Inc. Receives FDA Market Clearance for the SmartVest® SQL™

Electromed, Inc. (NYSE MKT: ELMD), a global medical device company, today announced it has received notification from the U.S. Food and Drug Administration that its next generation SmartVest® Airway Clearance System, the model SQL™ has been cleared to market.

“SQL solidifies Electromed’s innovation leadership by offering a device that is smaller, quieter, and lighter than our previous versions,” said Kathleen Skarvan, Chief Executive Officer. “We designed the SQL to stand apart from the competition with features that our patients and clinicians were asking for. They talked, and we listened.” In addition to being significantly smaller, quieter, and lighter than our previous versions, some of the features include enhanced ramping, an enhanced pause feature and more user-friendly graphics.

Published: 30 December 2013
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BIOLASE Granted Canadian License to Sell Its Flagship EPIC 10 Soft-Tissue Diode Laser

BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, today announced that it has received a license from the Health Canada-Medical Device Bureau to sell its EPIC dental soft-tissue diode laser systems throughout Canada. BIOLASE sells its products in Canada through a direct sales force and select distributors.

Chairman and CEO Federico Pignatelli commented, "With an estimated 19,000 dentists, Canada has historically represented one of BIOLASE's most robust markets for its high-tech laser products.

Published: 30 December 2013
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Valeant Pharmaceuticals Agrees to Acquire Solta Medical for $2.92 Per Share in Cash

Combination Creates a Global Leader in Aesthetics
Transaction Values Solta at Approximately $250 Million
Transaction Expected to Close in the First Quarter of 2014

Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced that it has entered into a definitive agreement under which Valeant will acquire all of the outstanding common stock of Solta Medical, Inc. (SLTM) for $2.92 per share in cash, which represents a 40% premium to Solta's closing share price on December 13, 2013, the last trading day prior to announcement, or a transaction value of approximately $250 million.  The transaction is expected to close in the first quarter of 2014 and Valeant expects the transaction, once completed, to be immediately accretive to Valeant's cash earnings per share. 

Published: 16 December 2013
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