A Medical Device Daily

The company said the 150,000-square-foot facility will support growing demand for biopharma services in the region, serving as a hub for packaging, global distribution and logistics management of tightly regulated pharmaceutical samples to patients participating in clinical trials.

Thermo Fisher Scientific is the global leader in high-end analytical instruments, laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety and education.

"We continue to make the investments required to grow our business — in this case expanding our capabilities to support growing clinical research and development markets in India," said President/CEO Marijn Dekkers, speaking at the facility opening. "With the added capacity now available to us with this new facility, we can offer our customers a higher level of technology, quality and expertise to facilitate clinical trials that serve the needs of both local and multi-national pharmaceutical companies."

Thermo Fisher has had a direct presence in India since 2000, and has accelerated its expansion in recent years. The company opened a demonstration laboratory in Mumbai in 2005 that offers customers hands-on experience with a range of laboratory solutions, and has since added sales and manufacturing facilities to support growing markets, including biopharma services and biospecimen storage, life sciences research and environmental analysis.

The company also completed two acquisitions that build on its presence in Mumbai. Qualigens Fine Chemicals, India's leading supplier of laboratory chemicals, was acquired in 2007, and the analytical technologies and environmental instrumentation divisions of Chemito, the country's largest local supplier of analytical instruments for life sciences and environmental monitoring applications, was added earlier this year.

Thermo Fisher said it now has the largest presence in India of any company in its industry, with more than 600 employees and 20 facilities.

Sonablate launched in India

In other India news, USHIFU (Charlotte, North Carolina), a developer of minimally invasive high-intensity focused ultrasound (HIFU) technologies, reported the establishment of India HIFU and the launch of Sonablate HIFU services in Hyderabad, India at Pramila Hospital for the treatment of prostate disease.

Dr. Ramesh Ramayya, president of urology and nephrology services at the hospital, said: "The introduction of the Sonablate 500 and the HIFU technology for the treatment of prostate cancer marks a major milestone in the practice of urology in the Indian sub-continent."

The Sonablate HIFU was launched at an event earlier this month at the Taj Krishna by Chief Minister Dr. Y.S. Rajashekar Reddy. Drs. Madhav Kamat of Jaslok Hospital (Mumbai) and A. Ranganadha Rao, past president of the Urological Society of India, were among the guests.

The first HIFU treatments in India were performed by Ramayya the next day.

"It is imperative that patients with prostate cancer are offered a viable alternative to the existing therapy options of surgery and radiotherapy," he said. "HIFU technology is minimally invasive, far safer than and as effective as existing alternatives."

Steve Puckett Jr., CEO of USHIFU, said, "We are ... enthusiastic about the growth opportunity in the Indian market. Using our unique hybrid medical device-service model we will be able to quickly enter all the major Indian healthcare markets without having to rely on sometimes slow hospital capital spending decisions. We are [pleased] to be able to expeditiously arm Indian physicians with an alternative modality to combat prostate cancer and the significant side effects associate with traditional treatments."

India HIFU is the exclusive distributor of the Sonablate system in India, and is responsible for marketing and developing Sonablate HIFU Centers throughout the country. It is affiliated with USHIFU and International HIFU, the entity through which USHIFU conducts its international business operations.

Australian clearance for Endo-PAT2000

Itamar Medical (Caesarea, Israel), a developer of noninvasive diagnostic systems using its Peripheral Arterial Tone (PAT) signal, said it has received Therapeutic Goods Administration clearance in Australia for the Endo-PAT2000.

Described as "the first simple, inexpensive, office-based diagnostic test for endothelial function," the Endo-PAT2000 is a noninvasive device that measures endothelial function, the earliest clinically detectable stage of cardiovascular disease, using biosensors mounted on patients' fingers that measure minute changes in vascular tone using Itamar's PAT Signal technology.

The company said the Endo-PAT2000 "adds an unparalleled dimension to the prevention of cardiovascular disease by enabling physicians to accurately measure endothelial function and modify patient management accordingly."

Saying the medical community "has long sought a cost-effective and reliable method to detect endothelial dysfunction," Itamar said the Endo-PAT2000 enhances the traditional clinical setting's diagnostic capabilities for endothelial dysfunction.

The Endo-PAT2000 can be used in any setting, from hospital bedside to outpatient clinic.

"Itamar Medical is proud to bring our innovative PAT Technology to the medically-advanced Australian market," said President/CEO Dov Rubin. "This is an important milestone for ... [our] penetration into the Asia Pacific markets."

Lorrence Platania, managing director of JLM Accutek Healthcare, the Endo-PAT2000 distributor in Australia, said: "This certification paves the way for patients in Australia to get tested with the Endo-PAT2000, providing them with a comprehensive picture of their endothelial cell function, a critical factor in cardiac health."

Canada OKs brachy treatment

Health Canada has cleared Nucletron's (Columbia, Maryland) Oncentra Brachy, a new volume-based brachytherapy treatment planning device.

Oncentra Brachy, a DICOM-compatible treatment planning system, features algorithms to shorten planning time, according to the company. Among the new solution's features are 3-D contouring and margining tools to identify regions of interests on CT or in multimodality imaging environments using image registration for CT, MR and PET data.