A Medical Device Daily

Calypso Medical Technologies (Seattle), a maker of real-time localization technology used for the precise tracking of tumors, and Elekta (Stockholm, Sweden), a designer of medical devices and software for treating cancer, reported a master development agreement to jointly develop products integrating the Calypso system with Elekta's radiotherapy treatment technologies.

The Calypso system is complementary to Elekta's technology for delivering intensity-modulated radiotherapy (IMRT), including Elekta Synergy and Precise linear accelerators. As one of the world's leading suppliers of linear accelerators and oncology software solutions, Elekta is committed to providing clinicians with open-systems connectivity to integrate third-party technologies. The goal of external beam radiation therapy is to focus the radiation beam on the tumor while avoiding the irradiation of surrounding healthy tissue. However, internal organ motion may cause the radiation to miss its intended target. The Calypso system, with its GPS for the Body technology, uses miniature implanted Beacon transponders to provide precise, continuous information on the location of the tumor in real-time during external beam radiation therapy.

“Integrating the Calypso system into Elekta's world-class radiotherapy technologies may facilitate the development of innovative treatment modalities for treating prostate cancer along with more problematic radiation therapy targets, such as the pancreas and lung,“ said Edward Vertatschitsch, PhD, president/CEO of Calypso Medical. “Near term development efforts include creating connectivity between the linear accelerator and the Calypso system for patient positioning during radiation delivery, which automates the process of re-positioning the treatment couch when the tumor moves out of a prescribed motion threshold. This agreement will also provide the framework for the potential development of real-time automated correction, a future capability with feasibility work already in progress at both companies, which enables motion management with the tumor target based on real-time tracking data provided by the Calypso system.“

In other agreements/contracts:

• NextGen Healthcare Information Systems (Horsham, Pennsylvania), a provider of healthcare information systems and connectivity solutions, reported an agreement with Wills Eye Health System (Philadelphia) to deploy NextGen Ambulatory EHR and NextGen Practice Management.

Wills Eye provides the full range of primary and subspecialty eye care, including cataract, cornea, retina and glaucoma treatment, neuro-ophthalmology, oculoplastics, ocular oncology, pediatric ophthalmology, refractive surgery, laser vision correction, diagnostics, low vision services, and emergency room coverage. Wills Eye also has a network of multi-specialty ambulatory surgery centers in the tri-state region.

Through this partnership, the NextGen integrated technology platform will connect the Wills Eye community, giving care providers ubiquitous access to electronic health records and enabling exchange of patient data at the point of care. This level of documentation will help provide the organization with the clinical reporting capabilities needed to demonstrate Meaningful Use.

“Wills Eye was a specialty institution from inception, so we needed a technology partner that could truly understand and support our ophthalmology-specific needs,“ said Joseph Bilson, executive director of Wills Eye. “NextGen Healthcare's long-standing reputation as a leader in the ophthalmology industry was a critical factor in our IT decision. We were also impressed with the company's commitment to helping us achieve Meaningful Use.“

NextGen Ambulatory EHR features exclusive ophthalmology content, including pre-built clinical templates and workflow, to ensure complete, accurate documentation stored in a standard format. Its disease management templates enable practices to capture discrete data at the point of care – a crucial component to qualifying for pay-for-performance programs.

• WaferGen Biosystems (Fremont, California), a provider of genomic analysis systems, and the Integrated BioBank of Luxembourg (IBBL) reported an agreement to establish a strategic relationship that will expand the use of the WaferGen SmartChip Real-Time PCR system throughout Europe.

The agreement includes the purchase of a SmartChip Real-Time PCR system by IBBL to provide genomic analysis services for its own research programs and to other groups in Europe. IBBL will use the SmartChip system for discovery and validation of gene expression patterns (biomarkers) on a single platform.

The two organizations also will co-develop molecular signatures for filing and approval in Europe for diagnostic research and commercial applications, based on the planned International Organization for Standardization (ISO) status of IBBL.

Additionally, the two organizations will pursue a research partnership in cancer and other areas of interest with the goal of furthering the development of treatment and therapies and will offer SmartChip Gene-Expression Profiling services in Europe using the SmartChip system.

In addition, WaferGen will establish its European headquarters at the IBBL facilities in the near future. WaferGen is locating its European Headquarters in Luxembourg as part of an agreement with the Luxembourg Government, which has recently launched a biomedical initiative to harness genomics technologies for the study of human health problems and grow Luxembourg's personalized medicine capabilities.

• Sparta Systems (Holmdel, New Jersey), the maker of TrackWise quality management software and compliance management solutions, said that Coloplast (Minneapolis), a supplier of intimate healthcare products, has selected Sparta's TrackWise Enterprise Quality Management Software (EQMS) to replace its customer complaint handling system.

Coloplast's decision to phase out its existing Lotus Notes-based system was made following a review of the needs of the business by a joint team from Coloplast and Sparta Systems. Additionally, Coloplast conducted a review of the complaint handling products and solutions being used by leading medical equipment manufactures and life sciences companies, determining that the TrackWise solution possessed the industry-wide reputation for ease-of-use, configurability and ability to integrate with existing applications that would meet and exceed Coloplast's demanding requirements.

Coloplast will transfer its existing complaint management process to the TrackWise platform. Once fully deployed, almost 300 of the company's customer care consultants will rely on the TrackWise solution for the logging and resolution of user complaints. The second stage will be to move validation documentation management and all controlled workflows into the TrackWise EQMS.

Coloplast's business includes ostomy care, urology and continence care and wound and skin care.