A Medical Device Daily
Chindex International (Bethesda, Maryland), a provider of international healthcare services and products in China, said it has received approval from that country's State Food and Drug Administration (SFDA) to introduce new products.
Among them are the da Vinci S Surgical System manufactured by Intuitive Surgical (Sunnyvale, California) and the AlexLaser manufactured by Candela (Wayland, Massachusetts).
Receipt of the SFDA certificates will allow Chindex to begin the sales process and launch marketing programs for these products, which the company said would bring "a wealth of new market opportunities."
Chindex CEO Roberta Lipson said, "We have been in preparatory discussions for many months with potential hospital customers in China related to the exciting da Vinci S product. We will now begin to move ahead with the sales process for the prospects in our pipeline."
She added, "In many cases, our customers will be required to go through a formal budgeting approval or tendering process as part of their procurement procedures. These steps could not be accomplished before the SFDA approval was in hand."
Lipson said Chindex also was pleased to receive regulatory approval for the AlexLaser, a Q-switched Alexandrite laser that is used for tattoo and pigmentation removal. "There is a substantial market in China for these lasers," she said, "and we are now finally able to offer a product to satisfy it."
Saying that both regulatory approvals faced the significant delays "that are unfortunately very common in the medical device approval process in China today," Lipson said, "We now look forward to the benefit that we will see from the addition of these key products to our portfolio.''
Chindex is the exclusive distributor of the da Vinci S Surgical System in mainland China and Hong Kong and maintains a nationwide sales and technical service team to support system sales in all major metropolitan areas.
The robotic technology from Intuitive Surgical is designed to extend the benefits of minimally invasive surgery to a broad base of patients.
Since its development and introduction in 1999, more than 850 da Vinci systems have been installed worldwide. Chindex has placed four systems in Hong Kong since introducing the system in that market in 2005.
The systems are all used in various departments for urology, gynecology, general surgery, pediatric, thoracic and ENT cases. An initial reference and testing site at the People's Liberation Army General Hospital in Beijing has been in service since January 2007, with nearly 100 robotic cardiac cases having been performed there.
Chindex provides healthcare services and supplies medical capital equipment, instrumentation and products to the Chinese marketplace, including Hong Kong. It operates its United Family Hospitals and Clinics, a network of private primary care hospitals and affiliated ambulatory clinics in China. The hospital network currently operates in the Beijing and Shanghai metropolitan areas.
New distribution setup for Microline
Microline Pentax (Beverly, Massachusetts) said it has restructured its distribution network in Europe, the Middle East and South Africa (EMEA). With the change, Microline now will serve all of its customers' and distributors' needs throughout the EMEA regions from its headquarters in Massachusetts.
"This new organization represents a significant milestone in Microline's strategy to support its international customers by directly providing its innovative line of surgical instruments for minimally invasive surgery," said Dr. Jean-Luc Boulnois, chairman/president/CEO. "With its new management structure, Microline will more closely involve its distributor partners in sales growth, market penetration and future technology expansion."
The company reported the appointment of Gert Priem as distribution manager EMEA. "We now have an increased ability to focus our sales of core products, together with direct and timely feedback to Microline in order to better serve our customers," he said.
Microline also has named Medical Device Safety Services as its authorized European representative.
A manufacturer of surgical laparoscopic instruments, Microline is a wholly owned subsidiary of HOYA (Tokyo).
The company's integrated modular laparoscopic instrument system consists of a selection of reusable handpieces that utilize a broad assortment of disposable tips.
NIOX Mino approved in China
Aerocrine (Stockholm, Sweden) said its hand-held airway inflammation monitor, NIOX Mino, has been registered for marketing and sale in China.
The company's method of measuring airway inflammation, using exhaled nitric oxide (NO) tests, has also has been incorporated into China's national guidelines for asthma management, and tests for airway inflammation have received a reimbursement code.
In December 2007, NIOX, Aerocrine's larger device, was registered by the Chinese SFDA. Clearance of NIOX Mino means the company's Chinese partner, Bioson, now can begin product sales for broad clinical use by Chinese physicians.
The newly revised Chinese National Guidelines for Asthma Treatment and Prevention state: "... exhaled nitric oxide can be used as a non-invasive marker of airway inflammation in asthma ... measuring airway inflammation is helpful in choosing the best treatment scheme for asthmatic patients."
The guidelines have resulted in a reimbursement code being designated for Aerocrine's method to measure airway inflammation. The company said the code is the first big step toward doctors using NIOX Mino, securing payments per test.
CyberKnife coming to Montreal
Accuray (Sunnyvale, California) said that Centre Hospitalier de l'Universite de Montreal (CHUM) has purchased a CyberKnife Robotic Radiosurgery System for installation at Hopital Notre-Dame du CHUM in Montreal.
CHUM, one of the largest radiation oncology centers in Canada, will use the CyberKnife System to treat both intracranial and extracranial tumors including those in the lung, spine and prostate.
Accuray said CHUM is one of the leading academic sites in North America for the number of accruals for protocols developed by the Radiation Therapy Oncology Group of the American College of Radiology.