• ATS Medical (Minneapolis) said that the FDA has granted the company approval to begin marketing additional sizes of its line of ATS Open Pivot mechanical heart valves. The company will add the 25 mm and 35 mm mitral valves to its U.S. product offering. ATS Medical makes cardiac surgery products and services.

• BSD Medical (Salt Lake City) reported on the completion of the FDA’s pre-approval audit for the PMA submission of the company’s BSD-2000 hyperthermia system, along with the completion of a routine quality system (QA)/good manufacturing practices inspection. FDA did not provide any written inspectional deficiencies (Form 483) at the conclusion of the on-site inspection. The FDA’s review of the company’s PMA submission is ongoing. FDA conducts a pre-approval inspection following submission of a PMA to verify that the company’s design and manufacturing processes meet the quality system regulations. BSD Medical is the leading developer of systems used to deliver hyperthermia therapy for the treatment of cancer.

• Clarient (Aliso Viejo, California) said that it has released its next-generation of PATHSiTE, an Internet-based flow cytometry program that enables pathologists, when evaluating their leukemia and lymphoma cases, to have complete control over the gating analysis on cell populations. Clarient launched its upgraded online tool through its partnership with De Novo Software. Flow cytometry is a well recognized tool in the management of serious cancers such as hematopoietic and lymphoid malignancies. The PATHSiTE web-based portal connects pathologists from around the U.S. to Clarient’s flow cytometry as well as the instrumentation and software technology needed to effectively analyze specimen data. Clarient is a technology and services resource for pathologists, oncologists and the pharmaceutical industry.