A Medical Device Daily
Varian Medical Systems (Palo Alto, California) reported that it has received the CE mark for the Varian Proton Therapy System, which is designed to help doctors to improve treatments and outcomes in many cancer cases.
The company noted that, with proton therapy, physicians can use higher doses of radiation to control and manage tumors while significantly reducing damage to healthy tissue and vital organs.
"[Getting the] CE mark is an important milestone in Varian's initiative to develop and market a compact system capable of intensity-modulated proton therapy in single- or multi-room facilities," said Lester Boeh, vice president of emerging businesses for the company."This is a clear demonstration of our ... commitment to provide the cancer treatment community and its patients with a clinically practical and commercially viable proton therapy system that meets accepted safety standards for medical equipment."
Issuance of CE-mark certification makes it possible for cancer treatment centers to begin ordering, installing, and using the Varian Proton Therapy System in regions where CE mark is required without having to obtain a site-specific clearance to use the important technology."Institutions from all parts of the world are pursuing this promising technology for cancer patients in their regions," Boeh said.
Through its own R&D and the acquisition of Accel Instruments (Bergisch Gladbach, Germany) in 2007, Varian has developed a comprehensive proton therapy system that utilizes the company's technology for particle beam generation, treatment planning, imaging, motion management, and information management technology.
Varian is a manufacturer of devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy, and brachytherapy. It supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices.
CE mark for Smartfil system
Aesthetic Sciences (Menlo Park, California) reported receiving the CE mark for its dermal filler delivery system, the Smartfil Power-assisted Injection System, providing clearance for sales throughout Europe.
The company said the Smartfil system is the first powered device approved to be used with dermal fillers and the first product in a new category of power-assisted injection systems.
President Becky Stirn said the company is developing its plans for commercialization."From our years of work at Collagen Aesthetics, we learned from doctors that proper placement of dermal fillers was very important to the quality and persistence of the aesthetic result. This system gives the doctor more control over injection technique."
Chairman/CEO Gary Petersmeyer said Aesthetic Sciences is interested in partnering with a major company in the field of dermatology that"can optimize the launch of this novel device."
Aesthetic Sciences said that in clinical studies with 100 patients and 25 doctors, the system demonstrated"unique benefits to the injection process."
The company said it believes the controlled and smooth injection flow provided by the new system will be well-received by doctors and patients.
Much of the clinical work was performed by Dr. Stacy Smith of Therapeutics Inc., along with physicians from the U.S., UK and Germany. Smith said,"Doctors noted improved precision in the placement of fillers, less fatigue and overall improved quality of correction when using the Smartfil system. Additionally, patients noted less pain and bruising with this system as compared to manual injections."
Dr. Steven Cohen, a plastic surgeon in San Diego, said,"I was very pleased with the fast learning curve, the control in injection afforded by this system and the elimination of injector fatigue. In my very busy practice, I could envision one of these flow devices in every treatment room."
In addition to the CE mark, Aesthetic Sciences is pursing regulatory clearance for the system in the U.S.
Distribution accord for DNASTAR
DNASTAR (Madison, Wisconsin), reported that it has expanded its worldwide distribution organization by entering into a distribution agreement for its ArrayStar product line for microarray gene expression analysis and RNA-Seq applications with Infogen Bioinformatics (West Lothian, UK).
Under the agreement, Infogen will have rights to sell DNASTAR's ArrayStar line in the UK, Ireland, Italy, Spain and Greece.
DNASTAR's software is used by molecular biologists in the areas of sequence analysis, microarray gene expression analysis and genomic visualizations. The company launched the ArrayStar product line in the summer of 2007 as an easy-to-use and inexpensive software alternative for expression analysis applications.
Subsequent additions have expanded the software's capabilities to include handling RNA-Seq applications from data generated from multiple next generation sequencing platforms.
As the use of these applications increases, the company has expanded distribution in both Asia and Europe.
Infogen is focusing its selling efforts on software used in microarray applications. The company has offices in the UK and in Milan, Italy.
Bob Steinhauser, DNASTAR director of marketing, said,"Infogen fits our needs very well. We believe that the local market knowledge Infogen will bring in gene expression, along with our growing product line, will be very beneficial to each of us."