• CISBIO (Saclay, France), a developer of diagnostic assays for the quantification of tumor markers, reported that the Mesomark Assay, the world's first in vitro test for managing patients with mesothelioma, an aggressive and deadly form of cancer, has been approved by the FDA. The Mesomark test is developed and manufactured by Fujirebio Diagnostics (Malvern, Pennsylvania). CISBIO is the exclusive distributor of Mesomark in Europe, where it is currently undergoing evaluation for clinical use. The Mesomark test is now accessible to physicians across the U.S. for monitoring patients who have been diagnosed with epithelioid or biphasic mesothelioma. The minimally-invasive tool requires only a blood sample.

FDA has granted 510(k) clearance to the Conceivex Conception Kit by Conceivex (Saranac, Michigan), a reproductive healthcare system designed for couples to use in the privacy of their own home. The Conception Kit contains fertility prediction tools, semen collectors and the only FDA-cleared cervical cap for conception, which are designed to be used together for up to three months in order to enhance a couple's opportunity to conceive. The cornerstone of the kit is the Conception Cap, which brings the semen in direct contact with the cervix for four to six hours, thereby increasing the opportunity for sperm to move into the uterine cavity and fertilize an egg. Each element of the kit works together to address the more common male and female issues that interfere with conception, including low sperm count, reduced sperm motility, a tilted cervix, timing ovulation, a hostile vaginal environment and a couple's position during sex.

• Impac Medical Systems (Impac; Sunnyvale, California), an Elekta company and provider of information technology solutions for anatomic pathology and oncology care, introduces the PowerPath Advanced Materials Processing (AMP) module. AMP enhances patient safety with expanded use of barcode technology to track case materials from accessioning to sign-out. AMP provides laboratories with significant opportunities to improve workflow efficiency, accountability and responsiveness, potentially resulting in revenue increases and cost savings.

• IntelliDOT (San Diego), which focuses on patient safety and workflow management solutions for healthcare, reported the CAREt Phlebotomy Specimen Collection (PSC) System, a laboratory module for safe and accurate specimen collection at the point of care. The CAREt PSC System is a wireless handheld device and specimen label printer, which links to IntelliDOT's existing solution for point of care medication administration, and uses the same handheld device. The system guides the phlebotomist or nurse through the specimen collection process by scanning a patient's barcode wristband. The patient's name is then displayed on the handheld device as well as the name of the tests that are due, the type of collection container required, the draw order and special handling instructions.

• Zoll Medical (Chelmsford, Massachusetts) reported that it has received FDA clearance to market the ZOLL M Series with Real CPR Help technology, enabling rescuers to instantly see and hear how well they are performing the rate and depth of CPR chest compressions. The company said that the M Series is its best-selling product to date. "Virtually all of the products we market now incorporate Real CPR Help technology to improve the quality of CPR that rescuers provide," said Richard Packer, president/CEO of Zoll. CPR achieves effective blood flow to feed oxygen to the heart and brain and is associated with a return of a "shockable" heart rhythm, making defibrillation possible later in the resuscitation event. Zoll provides technologies that help clinicians, EMS professionals, and lay rescuers resuscitate sudden cardiac arrest or trauma victims.

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