• bioTheranostics (San Diego) reported the launch of an expanded tumor-type database for its flagship product, CancerTYPE ID, and the launch of KRAS mutational testing. CancerTYPE ID predicts cancer origin in patients whose primary cancer was initially “unknown or uncertain“ using conventional diagnostics. Knowing the site where the cancer originated impacts physicians' therapeutic decisions, and the results of the CancerTYPE ID assay can help physicians select optimal therapies earlier in the diagnostic process. In tissue samples for which CancerTYPE ID returns a positive result for colorectal cancer, the availability of KRAS, a companion diagnostic test for anti-EGFR therapy, enables medical professionals to obtain additional valuable information and make individualized treatment decisions. KRAS will also be offered as a stand-alone test.

• CaridianBCT (Lakewood, Colorado) has received FDA approval for the Trima Accel Automated Blood Collection System Version 6.0. The latest version of the Trima Accel system includes the Auto Red Blood Cell (RBC) procedure, allowing for the collection of a ready-to-transfuse leukoreduced red blood cell product from donors and eliminating the requirement for post-procedure leukoreduction and addition of storage solution. “The Trima Accel V6.0 Auto RBC procedure brings a host of improvements and additional ease-of-use to blood centers and helps them meet the changing blood supply needs of hospitals,“ said Bob Cole, senior VP of CaridianBCT's automated collections business area. “By increasing efficiencies through streamlining operations and reducing the opportunities for error, the Auto RBC procedure will benefit blood centers.“

• N.M.B. Medical Applications (Thornton-Cleveleys, UK) reported FDA approval of the Quantum Humeral Composite Nailing System. The system is an intramedullary interlocking nail made of Endolign (from Invibio Biomaterial Solutions). Endolign, an inherently pure and inert composite of continuous carbon fibers in a Peek-Optimapolymer matrix, enables patient/surgeon benefits that can advance the treatment of long bone fractures. N.M.B. says the Quantum Composite Nail design combines with Enodlign's unique material characteristics and performance capabilities to challenge the limitations of Titanium and Stainless Steel.

• OrthoDynamix (Jacksonville, Florida) said it has received FDA clearance for its new device, ArthroSteer 3.5 mm Ablator, a mono polar electrosurgical device, for general surgical use, including the orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulating soft tissue in, but not limited to the knee, shoulder, and primarily the hip. ArthroSteer's technology improves triangulation and or orientation of its instruments in tight joint capsules enabling the surgeon greater access to damaged tissue. The 3.5 mm and/or its 5 mm high dexterity instruments have surgeon controlled 180 degree bend of the distal shaft while the tip can rotate 360 degrees on its axis, independent of the shaft.

• Pioneer Surgical Technology (Marquette, Michigan) reported the launch of its Contact Anterior Lumbar Plate (ALP). This plate provides a one-step locking mechanism along with back-out protection and controlled screw toggle. The plate was designed for optimum synergy with the company's Contact PEEK Anterior Interbody Spacer. “We have been extremely pleased with the positive responses we have received from our product evaluators. This product completes the Pioneer solution for anterior fusion procedures and the unique instrumentation platform provides the opportunity for greater OR efficiency,“ said company CTO Chip Bao.

• Predictive Biosciences (Lexington, Massachusetts) has introduced its Multi-Analyte Diagnostic Readout (MADR) approach to the development of a non-invasive, urinary biomarker based assay for the detection of bladder cancer during the 2010 Genitourinary Cancers Symposium. The MADR research, which combines protein and DNA biomarkers to identify with high certainty a group of bladder cancer patients who are disease free and could be excluded from undergoing invasive procedures, was conducted under collaboration agreements with Lahey Clinic Medical Center and Mayo Clinic. The MADR approach is being used by Predictive in the development of its CertNDx line of cancer assays, and is an extension of Predictive's Clinical Intervention Determining Diagnostic (CIDD) approach. CIDD was developed by Predictive to identify biomarker cutoffs that maximize negative predictive value in order to identify with very high certainty those who require no further intervention.

• Stryker Orthopaedics (Mahwah, New Jersey) reported the release of the ADM X3 Mobile Bearing Acetabular System, a technology for hip replacement surgery designed to minimize the risks associated with total hip replacement surgery. Stryker says this system is made possible due to its X3 advanced bearing technology which is designed to increase the longevity of the implant. ADM's dual points of articulation help accommodate multi-directional movement, which provide greater range of motion than fixed implant designs based on laboratory testing. In addition, the anatomic cup design has an iliopsoas tendon cut-out aimed at reducing iliopsoas tendon impingement, a key cause of post-operative groin pain.

• SynCardia (Tucson) said that its new Freedom driver system has received the CE mark to power the Total Artificial Heart in Europe. The Freedom driver weighs 13.5 lbs including two onboard lithium ion batteries and a power adaptor. It can be carried by the patient in the Freedom Backpack or Shoulder Bag. The Freedom driver is 60% lighter than SynCardia's older CE approved “proof of concept“ portable driver, which weighs approximately 35 lbs and is transported in a wheeled caddy.