A Medical Device Daily

Itamar Medical (Caesarea, Israel) reported that the Japanese government has granted Shonin clearance to for its EndoPAT, paving the way to widespread use in Japan for diagnosing endothelial dysfunction, a key cause of cardiovascular disease.

Endothelial dysfunction is the earliest detectable stage of cardiovascular disease. It precedes clinical symptoms by years, even decades. Multiple studies have demonstrated its key role in the development of atherosclerosis which leads to heart attacks, strokes and other fatal or debilitating diseases. The company said it is highly responsive to treatment, and patients who improve their endothelial function have been shown to suffer a lower rate of cardiovascular events.

"We are extremely pleased to receive the Shonin approval from PMDA. We truly believe that this official approval by our government may be the start of a very bright future for the EndoPAT in Japan," said Yasunori Noto, president of CCI, an Itamar Medical distributor in Japan.

Healthcare Solutions awarded Qatar contract

Healthcare Solutions (HCS; Dubai, United Arab Emirates), a leading provider of healthcare solutions in the Middle East, reported that the Ministry of Health in Qatar has awarded HCS a contract for the supply, installation, training and support of an HL7 interface engine to integrate their healthcare information system, PACS and blood analyzers, at the Medical Commission facility.

HCS provides total healthcare IT solutions in the Gulf Cooperation Council (GCC) covering consulting, products, services and system integration to meet an increasing demand for quality healthcare services throughout the region.

HCS is well-known as a pioneer in delivering the systems integration project for Enterprise Healthcare Sector in gulf region with unique integration experience in Dubai Government Department of Health & Medical Services (DOHMS).

The company will deliver this solution using the InterSystems Ensemble rapid integration and development platform from InterSystems (Cambridge, Massachusetts). HCS has had a partnership with InterSystems since 2002, supplying and supporting a number of InterSystems products in healthcare facilities throughout the GCC region.

IntraOp gets new orders from Chinese partner

IntraOp Medical (Sunnyvale, California), a provider of Intra-Operative Electron-beam Radiation Therapy (IOERT) solutions for the treatment and eradication of cancer, reported two new orders for its Mobetron system from its Chinese distribution partner, Hui Long New Technology.

IntraOp's Mobetron is a mobile technology that delivers IOERT to a tumor site during cancer surgery. The Mobetron enables radiation and surgical oncologists to pinpoint the optimal site for radiation and to deliver an effective dose during the procedure. Since the Mobetron is a mobile, self-shielded device, doctors are able to move the Mobetron among operating rooms to treat a greater number of patients more effectively, efficiently and cost-effectively than with a conventional linear accelerator.

This order marks the fifth and sixth Mobetrons sold in China. In the twelve months since installing and utilizing the first device, oncologists in China have had notable success with IOERT, inspiring other centers to follow suit. Earlier this year, IntraOp sold and shipped Mobetrons to two Shanghai medical facilities, where they are currently being installed. This most recent order of two Mobetrons is for hospitals that should be ready for installation early next year.

Peter Yu, IntraOp's Director of Far East Operations, noted, "With the very high patient loads our oncologists experience here in China, IOERT is often the only way to ensure that some patients are getting the radiation therapy treatment they need in a reasonable amount of time. With this order, we will be able to satisfy our customers' growing demand for a device that will enable them to deliver IOERT in the OR."

IntraOp CEO John Powers added, "This order represents our fifth and sixth Mobetron sale in China in just 18 months. This adoption rate demonstrates China's willingness to leap frog old technologies, while quickly adopting and standardizing on new technologies proven to provide superior outcomes.

PathoLase submits laser treatment in Canada

PathoLase (Chico, California) reported that it has submitted its new PinPointe FootLaser treatment for toenail fungus (Onychomycosis) to Health Canada for approval.

PinPointe has been awarded the CE mark certifying it has met European Union consumer health and safety standards, has been cleared for use in the treatment of toenail fungus in the EU, and can be offered by healthcare providers throughout Europe. Additionally, the treatment is FDA cleared for applications in dermatology, plastic surgery, and podiatry in the U.S.

Introduced in 2008, PinPointe FootLaser uses a patented laser technology to target the pathogens that cause toenail fungus. With PinPointe FootLaser, patients are treated safely and quickly with no drugs, no anesthesia and no pain. PinPointe's laser light passes through the toenail without causing damage to the nail or surrounding skin. Following the procedure, the new nail will grow in healthy and clear.