A Diagnostics & Imaging Week

Aspect Medical Systems (Newton, Massachusetts) and Nihon Kohden (Tokyo) reported that the Japanese Ministry of Health, Labor & Welfare (MHLW) has approved Aspect’s latest-generation BIS XP monitoring system for marketing in that country.

Earlier versions of BIS technology were originally approved in Japan in 2000 and 2001. The BIS XP technology will provide clinicians with a number of consciousness monitoring performance enhancements, and Aspect said it expects to ship the first XP monitors to Nihon Kohden this month.

“Nihon Kohden has been a tremendous partner in introducing BIS technology in Japan and has helped Aspect navigate through an increasingly complex regulatory environment,” said Nassib Chamoun, president and CEO of Aspect. “The Japanese market has been extremely receptive to BIS technology, and the MHLW approval of the BIS XP system will now enable us to provide our Japanese customers with enhanced functionality and product performance designed to better meet the needs of care providers and patients.”

BIS XP technology was introduced to the market in the U.S. in 2001 to provide performance improvements such as increased resistance to electrocautery artifact. More than 90% of BIS systems currently in use in the U.S. now run on the BIS XP platform, Aspect said.

“The success of BIS monitoring in Japan has generated demand for Aspect’s next-generation BIS XP monitor,” said Kazuo Ogino, president and CEO of Nihon Kohden.

BIS monitoring translates information from the electroencephalogram into a single number that represents each patient’s level of consciousness. This number – the BIS value – ranges from 100 (indicating an awake patient) to zero (indicating the absence of brain activity). Using the BIS value to guide administration of anesthetic medication, in conjunction with other vital signs, allows clinicians to make better-informed decisions to achieve optimal anesthesia.

Ubiquitous Echo technology developed in Japan

Japan’s National Institute of Advanced Industrial Science and Technology (AIST; Tokyo) has reported the development of a portable ultrasound echographic machine (Ubiquitous Echo) through joint research between AIST and the Hiroshima Institute of Technology.

The unit can be used in healthcare/beauty facilities or in the home to visualize the key components of the body (muscles, bones, subcutaneous fat) and give fat and muscle measurements.

Users connect Ubiquitous Echo to their computers and use the included software to collect detailed information about specific parts of the body. Unlike ultrasonic echography equipment traditionally used in medical examinations, the new device is inexpensive, and small and lightweight enough to be put into a bag along with a laptop computer.

AIST said the hope is that Ubiquitous Echo will help to prevent elderly people from being confined to their beds.

Hiroshima Institute of Technology is studying the relationship between ultrasonic images and health information, and from that research is developing various healthcare programs.

The institute and AIST have been working since 2002 on the development of a portable ultrasonic imaging device that could be used in healthcare. The product, which went on the market earlier this year, was developed with the cooperation of Healthy Step. The three parties are developing it through a new venture business known as Global Health.

Suros gets CE mark for ATEC System

Suros Surgical Systems (Indianapolis) said it has received CE-mark approval for its ATEC (Automated Tissue Excision and Collection) Breast Biopsy and Excision System and ATEC TriMark biopsy site identification system. The company said expects to sell its first ATEC system for use with stereotactic (X-ray) and ultrasound-guided breast biopsy in January.

The ATEC system includes the Pearl and Sapphire console units, all biopsy devices and the ATEC TriMark marker deployment system for post-biopsy site identification. The ATEC Pearl is designed specifically for stereotactic and ultrasound-guided breast biopsy, while the ATEC Sapphire is the first all-in-one unit compatible with any of the three primary diagnostic imaging modalities – stereotactic, ultrasound and MRI.

Suros said it pioneered vacuum-assisted breast biopsy using MRI guidance in 2002 and has multiple patents pending with breast biopsy in that imaging modality. MRI-guided breast biopsy is widely accepted as a preferred secondary screening tool for women at high risk for developing breast disease or cancer.

The ATEC Breast Biopsy and Excision System and ATEC TriMark are FDA-cleared. The ATEC system was approved by Health Canada in July for use in performing diagnostic breast biopsy and partial or complete removal of visible evidence of benign breast disease. Suros said more than 200 hospitals and breast centers across North America currently use the ATEC system exclusively for MRI-guided breast biopsy.

Elscint-Elbit merger completed

Elscint (Haifa, Israel) reported the closing of the merger by exchange of shares between Elscint and Elbit Medical Imaging (EMI; Tel Aviv), the indirect controlling shareholder of Elscint. Negotiations to form the deal were unveiled earlier this year.

Elscint ordinary shares have ceased to trade on the New York Stock Exchange, and it is now a wholly owned subsidiary of EMI. Elscint is engaged in two businesses: investments in life science enterprises, and hotel development and leisure. In the life sciences, it invests in start-up companies, providing business guidance.