Novadaq Receives FDA Clearance for SPY Endoscopic Imaging System

Novadaq(R) Technologies Inc. (TSX: NDQ), a developer of real-time imaging systems for use in the operating room, today announced the SPY(R) endoscopic imaging system has received 510(k) clearance from the U.S. Food and Drug Administration for use during minimally invasive surgery (MIS).

Novadaq's SPY "scope" combines the traditional features of a state of the art, high definition standard endoscope with the fluorescence capabilities of the SPY imaging system, which is currently used in a variety of open surgical procedures. SPY scope will allow surgeons performing minimally invasive surgeries to simultaneously perform visible light endoscopy and fluorescence visual assessment of blood flow and related tissue perfusion through a single endoscope.

Published: 14 July 2009
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Trinity Biotech Receives FDA Approval for Destiny Max in the USA

Trinity Biotech plc (NASDAQ:TRIB - News), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced the FDA approval and US launch of its high throughput haemostasis analyzer, the Destiny Max.

Trinity has today obtained FDA approval of its Destiny Max analyzer and is now launching the instrument in the U.S. market with immediate effect. The target market for the instrument includes university hospitals, high throughput general hospitals, high volume commercial laboratories and reference laboratories.

Published: 07 July 2009
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BioSyntech Reports Positive Results from Pivotal Trial for BST-CarGel(R) Cartilage Repair Device

BioSyntech, Inc. (TSX: BSY), a biotechnology company developing biotherapeutic thermogels for regenerative medicine, today announced statistically significant results from an analysis of patients who completed their 12 month follow-up in the BST-CarGel(R) randomized clinical trial. Specifically, statistically significant evidence of improved repair tissue quality due to BST-CarGel treatment was found during analyses of tissues biopsied from the knees of 22 patients. The ongoing multicenter pivotal trial is evaluating the ability of BST-CarGel to repair cartilage lesions in the knee when applied to a microfractured lesion compared to microfracture alone (control) in 80 patients. Final results on all 80 patients are expected in the first half of 2010.

"We are excited by these positive results, which will be highly supportive in our ongoing discussions with potential orthopedic partners.

Published: 17 June 2009
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STAAR Surgical Receives CE Mark Approval for KS-X Preloaded Hydrophobic Acrylic Lens Injector System

STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that it has received CE Mark approval for its KS-X Preloaded Hydrophobic Acrylic Injector for use in minimally invasive cataract surgical procedures. The CE Mark allows STAAR Surgical to market this foldable intraocular (IOL) KS-X lens delivery system in the European Union as well as other countries that recognize the CE Mark. It also signifies that STAAR's preloaded acrylic lens delivery system complies with applicable safety and quality standards.

STAAR has been offering the KS-X system, which mates a preloaded delivery system manufactured by STAAR Japan with an independently sourced acrylic lens, in the Japanese market for two years.

Published: 09 June 2009
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Angiotech Pharmaceuticals announces FDA 510(k) clearance of the Option(TM) Inferior Vena Cava Filter

Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Option(TM) Inferior Vena Cava (IVC) Filter in the United States, for use in both permanent and retrievable indications. Angiotech holds exclusive worldwide rights to market and distribute the Option IVC Filter, which it obtained in a license agreement with privately held Rex Medical, LP (Rex Medical), as previously announced in March 2008.

The Option IVC Filter is used for the prevention of recurrent pulmonary embolism (PE). The device is implanted, typically by interventional radiologists in a minimally invasive procedure, into the body's inferior vena cava to prevent PE.

Published: 08 June 2009
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