Medical Device Dailys?

First results from a proof-of-concept study of 10 diabetes patients confirm the viability of the everyday monitoring for a novel Swiss multi-sensor device for non-invasive glucose monitoring.

Patients logged 110 days wearing the sensor-loaded armband from Solianis Monitoring (Zurich) that captured data from 10 standard blood glucose measurements each day.

Though the data is transferred wirelessly to a standard pocket computer, there is no display of information for the patient and the data is sent to Solianis each evening for analysis.

The company notes several non-invasive devices for glucose measurements have shown promising results in measuring glucose levels under controlled conditions but failed to address the challenge of everyday conditions that include factors disruptive to reliable measurement, such as changing body temperature, microcirculation, sweat, moisture or thickness of different skin layers.

Tucked in an elastic armband, the Solanis prototype model called FM2b carries software onboard for a hardware package that includes multiple sensors, the electronics for signal generation, data storage, a battery and wireless communication.

CEO Mario Stark said that by the end of September, Solanis will complete two more study phases with concurrent product redesign, at which point the functional design will be frozen.

He told Medical Device Daily the next phase will test 16 patients with Type 1 diabetes over 25 days each.

He said Solanis is working with the University Hospital in Zürich for patient selection and support.

Stark said he expects to receive CE-mark approval and launch the monitor in Europe by 2010, targeted at the insulin-dependent diabetes population.

"Solianis' sensor technology lends itself to integration with other technologies," he said, adding that the glucose data can be integrated with insulin pumps as a feedback mechanism, ultimately leading toward a closed-loop system.

Later product generations will address all potential patients with diabetes and impaired glucose tolerance.

French laser will speed up 'lunchtime liposuction'

Ultrasound and lipodissolve injections introduced a short cut to body-shaping so minimally invasive they were popularly called "lunchtime lipo."

Recently the FDA gave the green light to introducing a line of powerful French lasers for lipolysis to zap unwanted fat even faster.

The FDA granted 510(k) clearance to Osyris, based near Lille, for a laser-assisted lipolysis device for the reduction of localized fat deposits and skin contraction in the face, chin, back, abdomen, arms, inner thighs and upper knees.

More popularly, starting at $2,500 per treatment, laser-assisted lipolysis is cleared by the FDA to treat double chins, love handles and saddlebags.

MedSurge Advances (Dallas) has exclusive U.S. rights to the device, called Lipotherm.

The diode lasers used for Lipotherm can be set as high as 25 watts of power, or three times greater than current lasers used to remove subcutaneous fat.

After applying a local anesthetic, the physician inserts the laser head through a small canula and controls the laser pulses to break fat cell walls, effectively liquifying the fat, which is either aspirated or is left to be absorbed by the body, depending on the treatment area and patient parameters.

A treatment session lasts from one hour to 90 minutes and patients can experience swelling and some soreness.

Osyris founder Jaouad Zemmouri, who transferred the technology out of the Université des Sciences et Technologie de Lille, said the FDA approval opens a significant opportunity for the company, as the U.S. represents 65% of the world market for medical lasers.

Zemmouri said he hopes to capture 10% of the American market for lipolysis, a potential he estimated to be worth $100 million in sales.

The French business daily Les Echoes, said Osyris reported 2007 sales of €7 million ($10.7 million) and bought a minority share of the Dallas-based distributor in March 2007.

Sales more than doubled over 2006 when Osyris reported €3.2 million ($5 million).

Chlamydia test from Roche OK'd

Roche Molecular Diagnostics (Pleasanton, California) said its new Cobas TaqMan CT Test v2.0 for detection of Chlamydia trachomatis has received CE-mark approval.

The company said the test is designed with a dual-target approach to help ensure reliability of test results even when mutations occur in the bacteria's cryptic plasmid DNA.

According to Eurosurveillance, an independent scientific journal, C. trachomatis is the most commonly reported sexually transmitted disease in Europe. Although it often causes no symptoms, Chlamydia can, if left untreated, lead to complications such as pelvic inflammatory disease or infertility in women.

"Unexpected mutations in the DNA of an infectious agent such as Chlamydia can disrupt laboratory testing and, by extension, proper treatment of patients," said Teresa Wright, MD, chief medical officer at Roche Molecular Diagnostics. "Because it is impossible to predict when these mutations will occur, we have designed this test to detect all Chlamydia strains that may cause a deletion in the cryptic plasmid, including the variant originally detected in Sweden in 2006."

Sorin chairman heads NewCorTec board

NewCorTec (Pomezia, Italy), developer of the BestBeat Left Ventricular Assist Device, has reported the appointment of Umberto Rosa as chairman of the board, effective immediately. He replaces Luigi Donato, who will continue to provide his support to NewCorTec as chairman emeritus.

Rosa is chairman of Sorin Group (Milan, Italy), and also serves as chairman of Nerviano Medical Sciences, the largest European center of industrial research in oncology.

"NewCorTec is an innovative company with an exciting future in an emerging and growing market," Rosa said. "I have followed with great interest the development of the BestBeat VAD and I look forward to helping the company to achieve their goals and become a partner of choice for patients, cardiologists and surgeons in the growing market of ventricular assist devices."