• Aperio Technologies (Vista, California) reported the launch of a digital pathology solution for Immunohistochemistry (IHC) designed specifically for the clinical market. Aperio's digital IHC solution allows pathologists to run quantitative IHC image analysis while reading slides on a computer monitor. The digital IHC system includes algorithms for HER2, ER and PR stained breast specimens for diagnosing digital slides for clinical use in pathology. In addition, the system comes with a suite of image analysis algorithms that can be tuned for different tissue types (e.g. breast, colon, prostate), stains (e.g. HER2, ER, PR, Ki-67, P53, EGFR), reagents (e.g. Dako, Ventana) or to correlate algorithm results with other test methods (e.g. FISH, CISH).

• Lantheus Medical Imaging (N. Billerica, Massachusetts) said that the FDA and Health Canada have approved the company's supplemental applications to qualify the Australian Nuclear Science and Technology Organization (ANSTO) as a valid supplier for low-enriched uranium (LEU)-derived molybdenum-99 (Mo-99) in the U.S. and Canada, respectively. Mo-99 is the parent isotope of technetium-99m (Tc-99m), the medical isotope used in approximately 80% of all nuclear medicine procedures. Mo-99 is produced by the irradiation of uranium "targets" in a reactor. There are only few major worldwide suppliers of Mo-99, and most use highly-enriched uranium (HEU) targets. With these approvals, Lantheus says it will become the first domestic company to offer technetium-99m (Tc-99m) using Mo-99 derived from LEU targets to the U.S. and Canada, reinforcing its commitment to ensuring reliable supply and global access to Tc-99m.

• Life Spine (Hoffman Estates, Illinois) received FDA clearance for its FS3 minimally invasive spinal system. The FS3 MIS features cannulated wire-guided minimally invasive surgery implants and instrumentation to accommodate a range of patient pathologies through a percutaneous or open approach. Intuitive design allows for fast, reliable, and reproducible access and implantation with minimal exposure and tissue dissection. Michael Butler, Life Spine's president/CEO said, "This is the first of many new minimally invasive innovations that Life Spine is bringing to market over the next six months. In addition to our already diverse product offering, the FS3 posterior MIS screw system marks our fourteenth product to market and further strengthens our position as an engineering centric operation focused on bringing surgeon concepts to life."

• Merge Healthcare (Milwaukee) reported the release of Frontiers 4.2.2, a surgery management solution that improves hospital workflow by capturing and charting clinical data throughout the entire perioperative-care process (pre-surgical screening, operating room and recovery). Frontiers automates the demanding clinical and business documentation requirements in the operating room, allowing clinicians and physicians to better focus on patient care. Frontiers 4.2.2 introduces the ability to capture each surgery-related charge at the point of care, as well as to transcribe physiological data at any existing Windows-based charting station within a hospital. Using this electronic surgical record, hospital administrators have access to detailed data that can improve enterprise-wide processes while enhancing profitability and compliance efforts.

• Osmetech (Pasadena, California) received FDA clearance for its eSensor Cystic Fibrosis Genotyping Test for use on the eSensor XT-8 system. This multiplex test is used for cystic fibrosis carrier screening for adults of reproductive age, as an aid in newborn screening for cystic fibrosis, and as a confirmatory diagnostic test for cystic fibrosis in newborns and children. Osmetech said that it expects further commercial progress in 2009 by expanding the eSensor XT-8 test menu to include an extended Warfarin Sensitivity Test panel that includes CYP 4F2, a CYP 2C9 Genotyping panel, a venous thrombosis panel of Factor V, Factor II and MTHFR and a Respiratory Virus Pathogen panel.

• Spectranetics (Colorado Springs, Colorado) has received FDA clearance to market the Turbo-Tandem, a single-use, disposable device indicated for atherectomy of infrainguinal arteries. The Turbo-Tandem system is comprised of two integrated devices, a 7 French laser guide catheter in combination with a 2.0mm excimer laser ablation catheter. The Turbo-Tandem is designed to perform atherectomy and ablation of plaque in arterial lesions above the knee, primarily within the superficial femoral and popliteal arteries, restoring blood flow to the lower extremities. The angled ramp at the tip of the guide catheter allows the physician circumferential guidance and positioning of the laser catheter within the vessel, and push-button control greatly simplifies use of the Turbo-Tandem for repeated passes through the vessel.