• Abbott (Abbott Park, Illinois) said that it received FDA approval for its fully automated HTLV-I/HTLV-II blood screening test for use on the Abbott Prism instrument. The test is intended for use by laboratories to screen individual donations of blood and plasma for antibodies to human T — lymphotropic virus Type I and/or human T — lymphotropic virus Type II (anti-HTLV-I/HTLV-II). HTLV-I and HTLV-II are closely related but distinct retroviruses associated with several diseases including human T-cell leukemia and neurological disorders, according to the Centers for Disease Control. The Prism instrument consolidates testing into a single system automating many of the manual testing procedures and steps currently used to screen blood. Safety features built into the system help track and monitor each sample throughout the testing process providing documentation and quality control for testing facilities. The Prism system can run 160 samples per hour, making it possible to test more than 1,200 samples per eight-hour shift. Abbott Diagnostics makes in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics.

• Abiomed (Danvers, Massachusetts) said it has received FDA Humanitarian Device Exemption (HDE) supplement approval on system upgrades for its AbioCor Implantable Replacement Heart (AbioCor). The AbioCor is intended to replace the severely damaged native heart for patients who are not eligible for a transplant and have no other treatment alternative. The AbioCor sustains the body’s circulation and is designed to extend the lives of patients who would otherwise die of heart failure, while also offering a probable benefit for a satisfactory quality of life. The AbioCor is the first completely self-contained artificial heart that may allow patients more time at home, without wires or tubes piercing through their skin. This technology provides patients with complete mobility and remote diagnostics. The AbioCor is the only artificial heart without wires piercing through the skin, reducing the chance of infection. Its remote diagnostics allow patients to return home where they can resume normal activities including bathing. The AbioCor is able to pump blood through the body, simulating the rhythm of a heartbeat. Abiomed makes devices specializing in circulatory support to acute heart failure patients.