A Diagnostics & Imaging Week

The consolidation movement in the clinical diagnostics sector is expected to drive escalation of the number of tests for processing, which, in turn, will drive the clinical diagnostics automation market, according to consulting firm Frost & Sullivan (F&S).

New analysis from F&S's Sao Paulo office, "Brazilian Clinical Diagnostics Automation Markets," finds that this market earned revenues of $31 million in 2007, estimating this to reach $49.5 million in 2012.

"Dealing with a massive number of samples is a time–consuming process and implies higher possibilities of error," says Tania Mito, F&S research analyst. "Automation can alleviate this problem by optimizing the use of laboratory resources, resulting in faster and safer processes."

Moreover, Mito said, automation could serve as a significant differentiation factor in a consolidating market. "Automation solutions can optimally use laboratory resources, help standardize procedures, and reduce human involvement," she said. "These competitive advantages will improve quality and speed of services, accuracy of results, and reliability of tests."

"Despite their advantages, budget restraints of the Brazilian healthcare market and the high initial investments required for automation technology has deterred several laboratories from adopting this technology. In addition, end users do not fully appreciate the benefits of reduced labor requirements, since labor costs are extremely low in Brazil."

While reduction of human resources is expected to compensate for the costs of automating laboratories in the U.S. and Europe, the concept of labor cost savings has not caught the fancy of investors in Brazil. F&S said market participants can remedy this situation by promoting automation's long–term benefits such as safer and faster procedures as well as results that are more reliable.

Sonomed gets China SFDA approval

Escalon Medical (Wayne, Pennsylvania) said its Sonomed subsidiary has received approval from the State Food and Drug Administration of China to market the PacScan and E/Z–Scan lines of products in that country.

The PacScan line consists of A–scans, pachymeters and combination systems used in both cataract and refractive surgery. The E/Z– Scan line consists of both B–scan and A/B–scan systems for enhanced diagnostic capabilities. Both systems are widely marketed internationally and have become some of the best–selling ophthalmic biometry and ultrasound imaging systems in the world, according to Escalon.

The company said has immediate plans to market both series of instruments through its two existing distributors in mainland China, the Hwa–In Group and Shenzhen K&K, and also plans to increase its direct support network to assist distributors, attend regional meetings, and provide training as needed.

Barry Durante, president of Sonomed, said, "These instruments will provide physicians the opportunity to offer a safe and accurate ultrasound examination to improve their diagnostic capability and patient surgical outcomes."

Sonomed is a diagnostic ultrasound company specializing in the manufacture of instruments for ophthalmology, serving ophthalmic physicians' offices, clinics and hospitals.

The PacScan and E/Z–scan lines were showcased at the 8th International Congress of Ophthalmology and Optometry China in Nanjing, China, this past weekend.

U.S. trial starts for MediGuide/Philips product

MediGuide (Haifa, Israel) and Royal Philips Electronics (Amsterdam, the Netherlands) said they have started their planned clinical trials in the U.S. using the Philips Integris Allura Flat Detector catheterization lab (Allura FD–10) integrated with MediGuide's Medical Positioning System (gMPS) technology.

The trial at Columbia–New York Presbyterian Hospital (New York) is being conducted under an investigational device exemption (IDE) and uses the MediGuide gMP Enabled Guided Measurement Catheter (GMC) with the integrated Philips–MediGuide technologies. The gMPS system and GMC device are CE–mark certified and are limited to investigational use only in the U.S.

Philips and MediGuide have been cooperating since 2003 in the field of cardiac navigation. The gMPS system is used for intravascular evaluation of coronary anatomy and is intended to enable real–time tip positioning and navigation of a gMPS–enabled diagnostic or therapeutic device used in coronary or cardiac intervention in the cath lab environment, on both live fluoroscopy or recorded background.

The system is indicated for use as an adjunct to coronary angiography.

The gMPS–enabled GMC intravascular device is intended to be used in conjunction with conventional X–ray angiography systems to enable real–time tip positioning and navigation, quantitative length measurement, 3–D lumen reconstruction, qualitative 3–D foreshortening indication and landmarking, in patients who are candidates for coronary angiography and/or percutaneous coronary intervention.

The trial is being conducted by Drs. Giora Weisz and Jeffrey Moses of Columbia–New York Presbyterian. After the first patient procedure, Moses said, "The system performed beautifully. It is the first step of moving beyond fluoroscopy in coronary intervention. The potential here is enormous."