• AspenBio Pharma (Castle Rock, Colorado) reported that it has outlined plans for submitting its final data package to the FDA for market clearance of AppyScore, the first blood-based screen/triage test for human appendicitis. AspenBio said that emergency room physicians will be able to use the device as part of a complete clinical workup. The key metric for the clinical study is the device’s Negative Predictive Value, which has been shown consistently in pre-FDA clinical studies to be approximately 98%. In order to receive FDA 510(k) clearance, AspenBio must successfully demonstrate the performance characteristics of its final GMP-validated device. This includes non-clinical laboratory performance testing, like assay precision and analytical sensitivity, as well as clinical testing in the field. AspenBio has selected a manufacturer for the AppyScore Screen Test with experience in manufacturing in vitro diagnostic devices, according to 21 CFR 820, and which has been registered with the FDA to manufacture these types of devices. AspenBio is a biopharmaceutical company developing diagnostics and drugs for humans and animals.

• Baxa (Denver) reported the introduction of the Repeater Pump II, designed to provide accurate delivery of pharmaceutical solutions into a variety of containers, without the need for calibration. The pump uses a fixed-volume pumping design commonly refered to as “positive displacement.” The positive displacement nature of the pump eliminates the need for calibration or adjustment, providing accurate liquid delivery regardless of source container, final container, tubing diameter, and fluid viscosity, according to the company. Baxa is focused on manufacturing solution-based technologies for fluid handling and delivery.

• A new line of tracheostomy tube holders that are offered with designs for babies, kids, and teens is being introduced by Dale Medical Products (Plainville, Massachusetts). The PediPrints Tracheostomy Tube Holders feature the new PediDucks, PediStars, and Blue designs for babies, kids, and teens which are printed onto latex-free neckbands that are moisture repellent and ensure a snug fit without compromising security. The fastener tabs are shaped to fit into the flange of any size trach tube, these trach holders have rounded hook-and-loop back tab fasteners for sizing. The tube holders assure a snug fit for necks from neonate to 19-1/2”. PediDucks neckbands are 3/4” W, Pedi-Stars and Blue are each 1” W and they fit all brands of tracheostomy tubes to help prevent accidental dislodgment or displacement, trachesophogeal fistula, tracheal stenosis, or airway ganuloma. Dale Medical makes patient care products.

• Power Medical Interventions (PMI; Langhorne, Pennsylvania) reported FDA 510(k) clearance of its iDrive surgical devices. The iDrive family of devices is a suite of reusable, self-contained, hand-held devices that can be used to power and control PMI’s existing suite of Digital Loading Units, including linear cutter, right-angle linear cutter, and circular staplers. The company’s first generation of technology, the SurgASSIST, required the use of an external power console, flexible drive shaft and separate remote control unit. These functions can now be performed by a single hand held iDrive unit, according to Power Medical. The iDrive has been cleared for a range of applications in open and endoscopic surgery that have indications for gastrointestinal, gynecological, general abdominal, thoracic and vascular surgical procedures for resection, transection, creation of anastomoses and for open occlusion of the heart’s left atrial appendage. Power Medical says that it makes “intelligent” surgical instruments.

• Sequenom (San Diego) reported New York State approval of the first non-invasive prenatal test based on Sequenom’s SEQureDx Technology for Cell Free Fetal Nucleic Acid assessment. The laboratory developed test (LDT) performed on a real-time PCR (RT-PCR) platform to detect Rhesus D (RhD) incompatibility will be marketed by Sequenom’s nonexclusive licensee, CLIA-certified, New York State Permitted laboratory Lenetix Medical Screening Laboratory, Inc., Mineola, New York. RhD blood group incompatibility between a pregnant woman and her fetus is a significant problem due to the possibility of maternal alloimmunization and consequent hemolytic disease of the newborn. Alloimmunization most frequently occurs when an RhD negative mother is exposed to red blood cells of an RhD positive fetus, producing maternal antibodies against the RhD antigen. Although the pregnancy in which alloimmunization first occurs results in an unaffected child, future children are at substantial risk of anemia and in the worst cases, fetal death, according to Sequenom. Sequenom makes genomic and genetic analysis products for research and the molecular diagnostic markets.