• Avista Capital Partners’ (North Billerica, Massachusetts) recently acquired medical imaging business (MI) reported that the FDA has granted pediatric exclusivity for studies conducted on Cardiolite (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) under Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) as amended by the Best Pharmaceuticals for Children Act (BPCA). This grant extends the marketing exclusivity of Cardiolite for an additional six months beyond patent expiration on Jan. 29, 2008. Avista invests in medical imaging businesses.
• Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) reported the availability of an ultra high-density microarray, Affymetrix based technology (Whole-Genome Sampling Analysis). The offering continues the recent advances in LabCorp’s clinical genetics laboratory diagnostics. In 2005, LabCorp first offered the comparative genomic hybridization (CGH) based microarray diagnostics which focused on mental retardation and developmental delay. This targeted testing underscored the need for higher density whole genome coverage. The Affymetrix-based technology provides analysis of DNA copy number changes – identifying deletions, gene amplifications and loss of heterozygosity (LOH). LabCorp makes new diagnostic technologies.
• Siemens Medical Solutions (Concord, California) received FDA clearance for the sale and distribution of its most recent innovation in radiation therapy technology, the Artiste solution. Developed by Siemens’ Oncology Care Systems, the Artiste is a linear accelerator engineered specifically for adaptive radiation therapy (ART). This radiation therapy solution offers clinicians multiple imaging modalities. From Megavoltage (MV) to gold-standard, in-room CT imaging, clinicians can select the optimal imaging application for their treatment approach. Siemens’ MVision cone beam imaging package delivers outstanding soft-tissue resolution, especially in challenging cases, such as imaging prostheses and with large patients. The CTVision CT-on-rails system provides in-room, diagnostic quality imaging; thus opening up opportunities to implement benchmark concepts, such as daily re-planning.
• T2 Biosystems (Cambridge, Massachusetts) reported significant research findings that support the advancement and development of nanoparticle-based, magnetic resonance technology that offer rapid, portable diagnostic testing. This new research demonstrates new methods of advancing and developing magnetic resonance-based diagnostics that offer improved speed, accuracy and efficiency as well as portability to a broader range of settings including doctor’s offices, homes and hospitals. These findings show the feasibility of T2’s portable diagnostic system, building on dozens of prior published research studies by scientists demonstrating the ability of the nanoscale MR-based technology to detect target substances in diagnostic tests, including small molecules, single viral particles, bacteria and cancer biomarkers. T2 biosystems makes portable diagnostic products.
• TomoTherapy (Madison, Wisconsin) said that it has begun shipping a faster version of its proven platform for image-guided, intensity-modulated radiation therapy (IG-IMRT). Version 3.1 of the TomoTherapy Hi-Art treatment system includes new software and hardware features that enhance clinical productivity and system usability, and are expected to increase patient throughput. Software highlights of Hi-Art version 3.1 include a variety of delivery system design improvements that eliminate delays in the treatment process. Hardware updates include the addition of a second planning workstation to facilitate parallel clinical workflow, and the introduction of the new high performance couch, which provides efficiencies in the quality assurance, imaging and treatment processes. TomoTherapy makes radiation therapy systems.