A Medical Device Daily

Thermo Fisher Scientific (Waltham, Massachusetts), reported the availability in Europe of its new Copeptin assay, which helps medical personnel quickly and accurately diagnose acute myocardial infarction (AMI).

Copeptin, developed by recently acquired B.R.A.H.M.S. (Hennigsdorf, Germany) is a patented biomarker for AMI and is detectible using a simple blood test that, in combination with a Troponin biomarker test, permits doctors to rule out or confirm the onset of a heart attack within minutes. Currently, physicians rely on an electrocardiogram in combination with Troponin which, in most patients with chest pain, cannot indicate AMI until at least 4 hours after the onset of symptoms and requires additional testing after 6 to 9 hours.

"We acquired B.R.A.H.M.S. to strengthen our specialty diagnostics offering, and today's news demonstrates how quickly that investment is adding value to our technology portfolio," said Dr. Yuh-Geng Tsay, head of Thermo Fisher Scientific's Specialty Diagnostics business. "Our company continues to push innovation in biomarker discovery and applications. The Copeptin assay shows that we're having an impact by helping physicians to be more effective at diagnosing disease, which ultimately improves patient health and also lowers the cost of care."

AMI is the leading cause of death worldwide. About 15 million patients visit an emergency room each year with symptoms, however, only about 10% are eventually diagnosed with AMI. The Copeptin assay allows physicians to provide immediate answers. It accelerates treatment, prevents heart damage caused by prolonged wait time and streamlines the treatment of non-AMI patients. Copeptin can save valuable time, healthcare resources and, most importantly, human lives. The test is now commercially available throughout Europe. In the U.S., Thermo Fisher is in the process of generating the data to support a 510(k) pre-market application for the test, and plans to submit the data to the FDA at the end of 2010.

IOptima gets EPO for IOPtiMate

IOptima (Ramat Gan, Israel) reported that it has received the European Patent Office (EPO) approval for its OT-134 laser based system, known also as IOPtiMate, for the non invasive filtration treatment of Glaucoma.

IOPtima, a company focused on developing technologies for Glaucoma treatment, developed a novel CO2 laser based system (IOPtiMate) which enables the performance of a swift simplified, efficient and cost effective filtration procedure for the alleviation of intraocular pressure. The IOPtiMate is designed to enable practitioners to provide a safe and efficient solution to relieve excessive intra ocular pressure which is the primary cause of damage to the optic nerve in glaucoma patients, and is expected to compete as the preferred first line of glaucoma treatment.

The patent approved is a broad based patent covering the company's unique concept of treatment and laser technology that they have developed for treating glaucoma.

According to Ami Eya, CEO of Bio-Light, "The EPO approval will enable commercialization of our systems in a protected and proprietary environment. It was a short while ago when we received the CE mark of approval and we are currently preparing for the implementation of our systems in the European markets parallel to the implementation in the Far East markets which has already begun. We are continuing our process of achieving FDA approval and expect to begin clinical trials in the U.S. shortly."

Life Pebble sends data with micro-transmitter

For micro-managing the vital signs of a patient, Toumaz Technology (Abingdon, UK) has released the Life Pebble in Europe.

Measuring less than one-half inch thick and 2.5 inches in diameter, and weighing 0.7 ounces, the Life Pebble can be strapped on any body part and begin continuously transmitting data for electrocardiography (ECG), heart rate, skin temperature and physical activity.

A three-axis accelerometer detects physical motion in a three-dimensional space, such as a slip-and-fall, and can be used to measure the extent of physical activity by the patient.

Life Pebble runs for five days of continual use on a single hearing aid battery

The data can be sent in a range of up to 50 feet to a USB thumb drive-style receiver that can either store data for later connection to a network or else can be plugged into a networked laptop for real-time transmission.

The acquired data is clinical quality, ready for incorporation into a patient's electronic health record and the Life Pebble ships with a software package to enable integration of the datasets into specific health informatic systems.

Carrying a CE mark, Toumaz suggests the Life Pebble can be used in a range of applications including professional sports and lifestyle monitoring as well as healthcare applications such as rehabilitation and assisted living programs.

Life Pebble employs Toumaz's Sensium platform for continuous data capture with local, embedded processing and wireless transmission at ultra low power. (Medical Device Daily, Nov. 2, 2007

Cardinal Health (Dublin, Ohio) and Texas Instruments (TI; Dallas) have licensed the Toumaz technology to develop intelligent medical devices (MDD, March 28, 2008).