• Chembio Diagnostics (Medford, New York) reported launch of its third HIV rapid test, HIV Stat-Pak Dipstick, completing its suite of rapid tests for use in HIV testing programs in international settings. This latest format, HIV Stat-Pak Dipstick, is the most cost effective of the three, the company said. The product will be sold to international relief programs for around $1 per test. HIV Stat-Pak Dipstick is based upon the same test strip as Chembio's other two HIV rapid tests but does not have the plastic housings they use to for sample collection, and other features, which reduce material, labor and shipping costs.

• Cook (Bloomington, Indiana) reported availability of the CODA balloon catheter to the endovascular market. The CODA is designed for temporary occlusion of large blood vessels and expanding vascular prostheses, and helps to improve stent graft geometry after implantation of an endograft during endovascular aortic repair (EVAR) of abdominal aortic aneurysms. The catheter is enhanced by a long, tapered-tip design that offering over-the-wire trackability to minimize blood vessel trauma. The bi-lumen shaft is designed to provide additional support during EVAR procedure and to facilitate rapid balloon inflation and deflation. CODA is constructed with latex-free balloon material to reduce possible allergic reactions. CODA has 100 cm of usable length and can be expanded to a maximum diameter of 32 mm, enabling physicians to easily work with blood vessels of varying size and shape to 40 mm.

• iCAD (Nashua, New Hampshire) reported release of its Second Look 700 Computer Aided Detection (CAD) system, addressing the needs of film-based breast care providers with higher patient volumes and existing or planned digital information and medical imaging systems. The system operates on a stand-alone basis or as an integrated component of the digital workflow. The Second Look 700 has a modular design, allowing acquisition of a small-footprint, low-profile early breast cancer detection workstation and to add software upgrades that support communication in DICOM for medical images; allowing communication with the HL-7 standard; and working in conjunction with other mammography information systems. The Second Look 700 can detect up to 72% of actionable missed cancers, iCAD said, and is offered with multiple operating points permitting management of the system's marking logic and cancer detection sensitivity. The company said the Second Look 700 is the only multi-modality CAD system available today, with an upgrade available to add breast MRI CAD processing and display to the iCAD workstation.

• Implant Sciences (Wakefield, Massachusetts) reported receiving FDA 510(k) clearance for marketing its new Ytterbium-169 radioactive source for the treatment of breast and other cancers. The company said it must take “other steps“ over the next six months before it commercialized the product, including registration of the radioactive source by the Massachusetts Radiation Control Program and receipt of a National Institute of Standards and Technology traceable calibration. It also will supply the new radiation source to several radiation oncologists for pilot evaluation of the radioactive source. The Ytterbium-169 source for accelerated partial-breast irradiation is administered on the tip of a wire into a lumpectomy cavity for eight to 10 short periods over four to five days. The source will be sold in conjunction with a portable shielding apparatus that Implant Sciences has developed.

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