A Medical Device Daily

Staar Surgical (Monrovia, California) reported the approval of its KS-Ni Preloaded Silicone Intraocular Lens (IOL) injector system by Japanese regulatory authorities.

The KS-Ni Preloaded Silicone IOL Injector System allows the surgeon to deliver Staar Japan's blue-blocker silicone IOL through an incision size of 2.6 mm as compared to the current 3.2 mm incision size. A smaller incision will likely induce less astigmatism and allows for quicker healing. The KS-Ni Preloaded System also provides for fewer steps in the delivery process of the IOL making the system more user friendly for nurses and surgeons.

"The approval of the KS-Ni Preloaded IOL Injector continues to highlight the rapid-fire launch of products that leverage Staar Japan's expertise in the area of preloaded delivery systems for foldable IOLs," said Staar Surgical President/CEO Barry Caldwell. "During the past week, Staar has received three different product regulatory approvals in the U.S., Europe and now Japan."

The company said the KS-Ni system has one-third fewer components, making the system easier to assemble and less costly to manufacture.

Staar said it is evaluating the opportunity to expand the system to other key markets.

A maker of minimally invasive ophthalmic products, Staar is the developer of the Visian ICL, a tiny, flexible lens implanted to correct refractive errors, as well as products designed to improve patient outcomes for cataracts and glaucoma

Telemedicine project in Bhutan

Welch Allyn (Skaneateles Falls, New York) said it and its distributor, Samden Technologies, recently assisted the Ministry of Health in the kingdom of Bhutan in implementing the Rural Telemedicine Project, an initiative to provide lifesaving treatment to patients living in remote areas through digital transmission of data between basic healthcare centers and the country's hospitals.

"Welch Allyn showed Bhutan's Ministry of Health that about 95% of critically ill patients in remote locations can benefit significantly from this basic telemedicine model," said Dr. Biren Sahoo, country manager, Welch Allyn India. "The Rural Telemedicine Project allows medical technicians at basic healthcare centers to easily send patient data to a hospital-based physician, who can quickly make a determination about testing, treatment and referrals."

Located in the foothills of the Himalayas, Bhutan has more than 700,000 residents, most of whom live in locations with little or no access to hospitals or physicians. Welch Allyn noted that Bhutan once was considered to be one of the most isolated nations in the world, "but has made strides recently to balance its ancient culture and tradition with modernization through the development of the Internet, mobile phone networks and cable television.'

The Rural Telemedicine Project connects Bhutan's basic healthcare centers to physicians at seven regional hospitals and the National Hospital in Thimpu using Welch Allyn PC-based CardioPerfect Workstation ECG software and Spot Vital Signs LXi devices, laptop computers, and electronic health record (EHR) software developed by Indian distributor Sciemed and partner Karishma Software to be compatible with the country's dial-up infrastructure.

The Rural Telemedicine Project began as a pilot program in 15 selected basic healthcare centers. The centers have been equipped with emergency medicine and trauma care facilities to allow technicians to follow instructions from the referring physician using the EHR.

Chindex, Vital Images in agreement

Chindex International (Bethesda, Maryland), a provider of Western healthcare products and services in China, and Vital Images (Minneapolis), a provider of advanced visualization and analysis software, reported an agreement to sell Vital Images' software as part of the Chindex medical product portfolio in China.

Vital Images' software is approved by China's State Food and Drug Administration for sale in China, and will be marketed by Chindex to hospitals throughout the country.

Chindex provides healthcare services and medical products to China-based hospitals and clinics, including more than 750 Level 1 trauma centers.

Vital Images software solutions are used by radiologists, cardiologists, oncologists, and other medical specialists to create 2-D, 3-D and 4-D images of human anatomy from CT and MR image data.

Roberta Lipson, president/CE) of Chindex, said, "Over our 28-year history in China, Chindex has installed top-quality medical equipment in over 3,000 hospitals throughout China and Hong Kong and many of these hospitals are repeat customers. We welcome the opportunity to offer Vital Images' advanced visualization software to our existing customer base, as well as to leverage this new supplier partnership to bring our products and excellent technical services to an even greater number of hospitals and healthcare facilities throughout the country."

Michael Carrel, president/CEO of Vital Images, said, "I believe we nicely complement [Chindex's] existing enterprise medical solutions and can work together to deliver advanced visualization products to China's nascent healthcare imaging market. This important milestone enables us to expand our reach and impact patient care on a broader level."

South Korean distribution set

Echo Therapeutics (Franklin, Massachusetts) said it has signed a license agreement with Handok Pharmaceuticals (Seoul, South Korea), which it termed "the largest diabetes care-focused pharmaceutical company in South Korea," under which Echo granted Handok rights to develop, market, sell and distribute Echo's Symphony tCGM System for needle-free, transdermal, continuous glucose monitoring in medical facilities and by diabetics in that country.

The Symphony tCGM System incorporates the Prelude SkinPrep System, a skin ablation control technology that allows for quick and painless removal of the outermost layer of the skin for transdermal drug delivery and glucose management.

The system is designed to provide both diabetics and medical professionals with a reliable, needle-free, easy-to-use, affordable and comfortable-to-wear continuous glucose monitoring device.

"This initial commercial partnering arrangement for our Symphony tCGM System is a strategically significant component of our plan to develop and market this important next-generation technology worldwide," said Patrick Mooney, MD, chairman/CEO of Echo Therapeutics.

Echo will receive an up-front license payment from Handok of about $600,000 and also will receive substantial milestone payments upon the achievement of key development, regulatory and commercial milestones.