A Medical Device Daily

OptiScan Biomedical (Hayward, California), a maker of continuous glucose monitoring systems for use in intensive care units (ICU), reported that the company's OptiScanner automatic bedside glucose monitoring system has received CE mark certification for use in the EU. The company plans to initiate marketing of the OptiScanner during 1Q12, and is presently engaging in dialogue with appropriate distributors in the various countries. Additionally, OptiScan is in active discussions with the FDA regarding the approval of the OptiScanner in the U.S.

The OptiScanner is a bedside glucose monitoring system that the company says overcomes the limitations of today's current handheld, manually operated glucose meters and provides physicians with the tools and information they need to best manage patient glucose levels in the ICU. The device combats both hyperglycemia and hypoglycemia through automated monitoring of patients' glucose in plasma, as opposed to whole blood. It is estimated that approximately 20% of ICU patients have pre-existing diabetes and an additional 40% to 70% of ICU patients suffer from “stress hyperglycemia“ or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain tight glycemic control.

“There is a very real crisis related to patient blood glucose levels that is being played out daily in ICUs around the world. With hyperglycemia, hypoglycemia and glucose variability all prevalent in ICU patients and associated with death, there is a significant need for technology that can enable tighter glycemic control through automated, accurate and near continuous glucose monitoring,“ said James Krinsley, MD, director of critical care at Stamford Hospital in Stamford, Connecticut, and Clinical Professor of Medicine, Columbia University College of Physicians and Surgeons. “Unfortunately, both the quality and manual nature of the current glucose monitoring technologies prevent ICU physicians from reaching therapeutic goals for their patients. The result is often that physicians set ICU patient glucose targets higher than they would like in order to avoid the more dangerous potential of hypoglycemia. A breakthrough glucose monitoring system would help correct this problem and increase ICU patient safety.“

Hologic focuses on cancer sceening at IPV

Hologic (Bedford, Massachusetts) will focus on two new, ready-to-market automated options for cervical cancer screening at the International Papillomavirus Conference & Clinical Workshop (IPV) Sept. 17th through Sept. 22nd in Berlin.

Hologic's ThinPrep 5000 STS (Sample Transfer System) and Cervista MTA (Medium Throughput Automation) system will be featured in the Hologic exhibit. When the Cervista MTA system is combined with the ThinPrep 5000 sample transfer system, small-to-mid-sized laboratories have a scalable, fully-automated solution for Human Papillomavirus (HPV) testing. Small-to-mid-sized laboratories typically run less than 12,000 HPV tests/year.

“Our new automated Cervista and ThinPrep systems represent a tremendous opportunity for our laboratory partners in markets recognizing the CE mark,“ said Rohan Hastie, VP/GM, Hologic Molecular Diagnostics. “These products are designed to provide the small and medium volume laboratory access to the most effective and efficient cervical cancer screening technology available, while allowing them the flexibility to address their specific productivity and throughput needs.“

The Cervista HPV HR test uses Invader technology to detect 14 high-risk types of HPV for cervical cancer screening. The ThinPrep 5000 STS system automates the sample transfer and bar code scanning of the vial. The Cervista MTA system automates the DNA extraction and HPV detection steps of the Cervista HPV HR test.

Hologic makes diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women.

Bausch + Lomb launches enVista IOL

Bausch + Lomb (Rochester, New York) reported the launch of its new enVista glistening-free, hydrophobic acrylic intraocular lens (IOL) at the 2011 Congress of European Society of Cataract and Refractive Surgeons (ESCRS) in Vienna, Austria.

The hydrophobic IOL combines aspheric, aberration-free Advanced Optics technology, designed to deliver enhanced contrast sensitivity and better vision quality, with a clinically proven glistening-free material. In addition, the enVista lens design is intended to minimize posterior capsular opacification (PCO), a common long-term problem with IOLs that can cause patient vision to become clouded post-surgery. These features combined into one platform with the enVista lens, provide surgeons the opportunity to optimize short-term and long-term outcomes for their patients.

“We are proud to innovate the hydrophobic lens category with an IOL that provides a high quality of vision and addresses the common issue of glistenings,“ said Robert Grant, chief executive officer and president, Global Surgical Business, for Bausch + Lomb. “It was important that we deliver an advanced hydrophobic lens that surgeons and patients can count on now and over the long-term, and data shows that we have achieved that with the enVista lens.“