• BioLucent (Aliso Viejo, California), maker of the MammoPad breast cushion, reported two new initiatives for imaging centers that utilize digital mammography: a new MammoPad specially designed for digital mammography equipment, and certification as a digital Softer Mammogram Provider. The new MammoPad cushion is larger than other versions, specifically designed to fit the larger surfaces of digital equipment. The FDA-cleared foam cushion is made of a radiolucent material that does not interfere with image quality. The certification program offers mammography facilities the opportunity to brand themselves as a certified digital Softer Mammogram Provider. Certified Softer Mammogram Providers receive MammoPad Select, a customizable marketing and communications program that it said is proven to encourage more women to have regular screening mammograms.

• Cyberonics (Houston) reported the initiation of three studies designed to add to the growing body of evidence supporting the unique mechanism of action of VNS Therapy in treatment-resistant depression (TRD). The studies, taking place at Duke University Medical Center, Emory University and University of Texas Health Science Center, are designed to identify areas of the brain activated by acute and long-term VNS Therapy and further establish the rationale for the long-term sustained responses that have been reported with VNS Therapy in TRD.

• Endologix (Irvine, California), which manufactures minimally invasive treatments for vascular diseases, reported receipt of FDA approval to begin marketing its next-generation Visiflex Delivery System for use with the Powerlink System for the minimally invasive treatment of abdominal aortic aneurysm. The company said it plans to introduce the Visiflex in the U.S. market through a controlled launch program to further develop targeted physician feedback and to build inventory, with full commercialization anticipated this fall. The Visiflex is designed to provide improved catheter flexibility for delivery of the Powerlink endoluminal stent graft device. An integrated radiopaque band marker on the outer sheath and molded component parts are expected to enhance catheter visibility and facilitate smoother withdrawal in difficult anatomies.

• Genesis Bioventures (New York) reported that the U.S. Patent and Trademark Office has granted a patent for the Rapid Prion Detection Assay technology developed by Prion Developmental Laboratories (PDL), a portfolio company of Genesis Bioventures. The PDL assays are easy-to-use strip tests that provide accurate results in less than an hour. U.S. patent No. 7,045,297 protects this method of testing for all transmissible spongiform encephalopathies in animals and humans.

• Imaging Diagnostic Systems (Fort Lauderdale, Florida) reported that the CT Laser Mammography (CTLM) system was recently featured in two European publications. An article appearing in a special edition of the European Congress of Radiology newsletter, Newstyle, discussed the principles of CTLM technology and research conducted at the Medical University of Vienna (Austria) with the CTLM system, as well as future applications. “Through molecular imaging with laser, an improved diagnosis of breast tumors has become possible – and without the slightest exposure to radiation,” the author stated. And European Hospital's April/May 2006 issue featured an article, “CTLM Seeing through the dense breast.” Imaging Diagnostic Systems is seeking FDA premarket approval for its CTLM system to be used as an adjunct to mammography.

• Medistem Laboratories (Scottsdale, Arizona), creating advanced medical therapies based on adult stem cells, reported its filing of a U.S. patent application for a new cellular technology to treat lower back ailments by addressing causal issues and developing methodologies to prevent disc degeneration. The Medistem discovery relates to the administration of one or more cell types to stimulate lumbar angiogenesis, decrease inflammation and stimulate regeneration.

• Micro Power (Hillsboro, Oregon), a provider of portable power solutions for mission-critical equipment, reported several upgrades to SecuraPack, its custom lithium battery pack designed to optimize battery system reliability and product safety. Upgrades include authentication, redundant protection circuits and Li-ion cells designed with enhanced safety.

• St. Francis Medical Technologies (San Francisco) said that in a randomized, controlled, multicenter study published in the June issue of Journal of Neurosurgery: Spine, patients suffering from degenerative lumbar spinal stenosis (LSS) with spondylolisthesis showed significantly greater improvement with a new, minimally invasive procedure, the X STOP Interspinous Process Decompression System, than with steroid injections and other non-operative treatments during a two-year follow-up period. Overall clinical success with steroid injections and other non-operative care was found to be only 12.9%. The X STOP is a titanium alloy implant that was approved by the FDA in November 2005 as the first non-fusion treatment to improve symptom severity and physical function for patients with LSS.

• SuturTek (North Chelmsford, Massachusetts), specializing in suturing devices, said that its 360-degree Fascia Closure Device is the first safe suturing device available to prevent inadvertent suture needle stick injuries during fascia closure, which according to the American College of Surgeons is when 59% of all suture needle injuries occur. The company said the 360-degree Fascia Closure Device is the only suturing solution with an FDA cleared claim that it “aids in the prevention of suture needle stick injuries.” It is the first Engineered Sharps Injury Prevention (ESIP) device that enables hospitals to comply with OSHA regulations and federal and state needle stick prevention and safety laws - reducing cost, risk, and liability exposure. The device combines an easy to use, ergonomic reusable device that can be sterilized in the hospital with economical, single-use, disposable needle-protected suture cartridges.

• Varian Medical Systems (Palo Alto, California) said it has received FDA 510(k) clearance that permits the use of the company's high-energy, ultra-precise Trilogy linear accelerators on an expanded range of medical conditions. The clearance also marks the introduction of Varian's new Trilogy Tx Image-Guided Radiosurgery model designed specifically for surgeons. Varian's Trilogy and Trilogy Tx machines now can be used for stereotactic radiosurgery as well as precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A prototype of the new Trilogy Tx model was exhibited at the American Association of Neurological Surgeons annual meeting last month in San Francisco.

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