• Biophan Technologies (West Henrietta, New York) reported that one U.S. patent has been issued to the company and another has been issued to one of its licensors who has granted Biophan exclusive worldwide medical rights. U.S. patent No. 6,980,848, “Optical MRI Catheter System,“ teaches the application of photonic technology in combination with miniature MRI receiver coils incorporated into diagnostic catheters, eliminating unwanted heating associated with electrical conductors. U.S. patent No. 6,980,865, “Implantable Shielded Medical Device,“ licensed to Biophan by Nanoset (East Rochester, New York), discloses a flexible and biocompatible shielding assembly for electrical conductors used with implantable medical devices. This patent covers use of nanomagnetic and carbon-based structures providing a range of electromagnetic shielding for internal electrical conductors, as well as a high degree of thermal isolation for tissues external to the shield.

• Cynosure (Westford, Massachusetts), a manufacturer of lasers and pulsed light sources, reported that it has received Class II medical device license approval from Health Canada to market and sell over-the-counter its laser-based TriActive LaserDermology System for the temporary reduction in the appearance of cellulite. The TriActive is Cynosure's flagship cellulite product that contains six low-energy diode lasers, mechanical massage and suction and localized cooling.

• dj Orthopedics (San Diego) reported the release of the DonJoy ArchRival, a pre-fabricated foot orthotic for the treatment of Subtle Cavus Foot. This medical condition usually causes a person to walk on the outer border of the foot, which diminishes its shock-absorbing capacity and causes the foot and ankle to become more vulnerable to repeated stress injuries. DonJoy's ArchRival is constructed with a reduced medial arch and recessed area under the first metatarsal head to accommodate the plantar-flexed first ray. An incorporated elevated heel allows for shock absorption and accommodation of tight calf musculature, often seen with Subtle Cavus Foot. In addition, each ArchRival is designed with X-Static Technology, silver coated fibers woven into the surface layer of fabric to assist in the prevention of pathogens, blisters and odors. The ArchRival is available in seven sizes and is designed to fit in most types of athletic and walking shoes.

• DOBI Medical International (Mahwah, New Jersey) has released the latest version of the Dynamic Optical Breast Imaging (DOBI) technology software for its ComfortScan breast imaging system, a near infrared based, non-invasive and non-ionizing imaging system designed to improve the diagnosis of breast cancer by identifying tumor angiogenesis. The Windows-based, ComfortScan 2.0 software suite consists of three individual elements: ComfortScan acquisition software for patient data acquisition; ComfortNet for image database management; and ComfortView for image processing and display, allowing reading and diagnostic interpretation by physicians. The company said the software advances in ComfortScan image acquisition and processing, with a number of improved image reconstruction techniques, are designed to help improve visualization of potential sites of angiogenesis within the breast. The company said the release of version 2.0 marks the completion of a milestone in its preparation for a larger, blinded multi-physician read, a key part of the final submission module of its FDA premarket approval application.

• Response Biomedical (Vancouver, British Columbia) reported that initial evaluations performed by independent public health organizations demonstrated that its rapid RAMP Flu A Test had significantly greater sensitivity than existing point-of- care diagnostic products. The company said it now plans to initiate multi-center clinical trials of its RAMP Flu A and Flu B tests during the current flu season. RAMP provides clinically relevant information in about 15 minutes, well within the 48-hour window of opportunity for administering antiviral therapy.

• Staar Surgical (Monrovia, California) reported that the first Visian ICL (Implantable Collamer Lens) has been surgically implanted in the U.S. since the FDA approved the premarket approval application for the lens in December. John Vukich, MD, ophthalmic surgeon and medical director at the Davis Duehr Dean Medical Center (Madison, Wisconsin), performed the procedure on Jan. 10. Vukich reported that post-operatively the patient's vision was “better than 20/20.“ The Visian ICL is the only foldable, minimally invasive lens approved for he correction of myopia, or nearsightedness, in adults.

• Thermage (Hayward, California) said that it has received regulatory clearance from the FDA for a new indication of the ThermaCool system that enables clinicians to perform Thermage procedures off-face for the non-invasive treatment of wrinkles and rhytids. Until now, the ThermaCool system was indicated for use in the U.S. for periorbital region and the mid/lower face. Similar to the Multi-Specialty Consensus Treatment Guidelines created for the face indication, Thermage is developing treatment protocols for different off-face procedures, including thighs, abdomen, buttocks and hands. The company is also creating opportunities for clinicians to share their experience with off-face procedures through educational forums, webinars, user workshops and speaking opportunities at various industry trade shows and conferences. In addition, Thermage is unveiling a new brand for its Thermage procedures, called Body by Thermage, to reflect the company's direction and encompass a full suite of procedures.

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