Diagnostics & Imaging Week

Medical Tactile (Los Angeles) is launching its Sure-Touch Visual Mapping System, a sensing device currently cleared only for documentation of clinical breast exam results, but that in about a year CEO Steve Weiss hopes ultimately will be FDA-approved for diagnostic screening of breast lesions.

The system was being shown at the 28th San Antonio Breast Cancer Symposium and was being offered for commercial sale for documentation purposes only at this point.

“I don’t know for sure, because it’s up to the FDA when they review our request, but it could take probably in excess of a year [to get a PMA],” Weiss told Diagnostics & Imaging Week.

He said he expects the FDA to require them to conduct clinical trials involving between 500 and 1,000 women.

Based on the company’s tactile sensing technology, the SureTouch Visual Mapping System uses sensors that are designed to detect lesions as small as 5 mm to improve the sensitivity, specificity and objectivity of manual breast palpation exams. The company said that such exams are the “most accessible first line of defense” against breast cancer for most women.

“We are very pleased to begin commercial sales of the first-of-its-kind SureTouch System,” Weiss said in a statement. “We have worked hard to develop an innovative, cost-effective technology that enables healthcare practitioners to improve early breast cancer diagnostics and save lives.”

The emerging company was founded in 2002 on the basis of the SureTouch breast palpation technology, which was developed at Harvard University (Cambridge, Massachusetts) by Jae Son, PhD, the firm’s chief technology officer.

Medical Tactile said the SureTouch System is designed to enhance and quantify the operator’s sense of touch during manual palpation in breast cancer screening. To use the system, the healthcare practitioner palpates suspicious breast lesions with the hand-held tactile probe, which is covered with a sterile sheath and uses a lubricating gel to go over the breast, much like ultrasound.

A tactile sensor, according to Medical Tactile, “consists of an array of pressure transducers which produce a digital signal as the sensor is pressed and moved against tissue.”

It also said that the “MTI tactile sensor technology provides greater sensing sensitivity and repeatability than competing technologies and is up to four times as sensitive as the human sense of touch.”

The company described it such that “just as a digital camera captures the sense of sight, MTI’s tactile sensing technology captures the sense of touch.”

The probe is attached to a console on which the image is displayed and the electronic record of the digital image is recorded. It also comes with a calibration scale to set and adjust pressure sensors on the tactile probe.

Weiss said that the SureTouch system console creates an electronic record that provides information to help recognize suspicious lesions, a record that can be given to the patient to take home. If there is an abnormal report, it provides the estimated size and shape of the lesion and is sent to the radiologist with the patient’s records.

“It helps [radiologists] look at their mammograms and ultrasounds, because they know what to look for,” he said.

The SureTouch System is the company’s first commercially available tactile sensing device. However, other breast cancer detection products based on its technology are in development.

The company’s technology partner is Artann Laboratories (West Trenton, New Jersey), which it said brings “expertise in soft-tissue mechanics” to Medical Tactile.

The company is funded by private investors, and also receives funding through a National Institutes of Health (NIH; Bethesda, Maryland) grant, Weiss said.

In addition to the San Antonio Breast Cancer Symposium, Medical Tactile will be displaying the system in 2006 at the National Consortium of Breast Centers conference in Las Vegas on March 11-15 and at the American Society of Breast Surgeons meeting in Baltimore April 5-9.