Cepheid (Sunnyvale, California) has introduced its GeneXpert Infinity-48 high-throughput system, as an addition to its GeneXpert family of molecular diagnostic testing systems. Cepheid says the GeneXpert system is a self-contained, integrated system that automates molecular analysis with minimal risk of contamination. The GeneXpert combines on-board sample preparation with real-time polymerase chain reaction amplification and detection functions for nucleic acid analysis. Cepheid is a molecular diagnostics company that makes systems for genetic analysis in the clinical, industrial and biothreat markets.
Escalon Medical (Wayne, Pennsylvania) reported receiving FDA clearance for the LIASYS benchtop clinical chemistry and immunoturbidimetric analyzer. The instrument features primary tubes sampling, capacitive liquid level sensing, positive identification of the samples, and a module for ion selective electrode. Escalon says that LIASYS multi-tasking and software enhances the system's performance. Escalon makes ophthalmic diagnostic, surgical and pharmaceutical products as well as vascular access devices.
HepaLife Technologies (Boston) reported process improvements for cell manufacturing and storage, key factors in cost-efficiently producing enough cell-based liver devices for in-vivo trials and clinical application. HepaLife says that efficient large-scale manufacturing of its PICM-19 liver stem cells is a key consideration in the operation of the company's bioartificial liver, since scientists anticipate that tens of billions of cells will be needed inside the device's bioreactor system. HepaLife makes cell-based technologies.
ImaCor (Uniondale, New York) reported receiving FDA clearance for its ClariTEE probe and Zura imaging system. The ClariTEE probe is a miniaturized transesophageal echocardiography probe which facilitates episodic monitoring of cardiac function. The ClariTEE is a single-use device that can remain indwelling for up to 72 hours, allowing intensivists and anesthesiologists to periodically assess cardiac preload and left ventricular systolic function over a prolonged period of time. ImaCor makes solutions for monitoring cardiac function in the critical care environment.
InfoLogix (Hatboro, Pennsylvania) said that it has launched a new mobility assessment service for hospitals that enables them to plan, build and support a complete future-state mobility infrastructure. The service is designed to provide healthcare organizations with an independent roadmap of their mobility infrastructure, and how to support both current and long-term needs. InfoLogix is a provider of enterprise mobility and advanced wireless asset tracking solutions for healthcare and other industries.
Millipore (Billerica, Massachusetts) reported the launch of its OxyELISA oxidized protein quantitation kit, providing all of the reagents necessary for quantitative, high throughput detection of modified proteins in cells undergoing oxidative stress. Oxidative stress is a cellular condition particularly relevant to aging and age-related diseases, such as Alzheimer's disease, Parkinson's disease, and dementia. As result of oxidative stress, oxygen free radicals and other reactive species introduce carbonyl groups into proteins in the cell. The OxyELISA kit detects these carbonyl groups, which are hallmarks of the cellular oxidative stress level. Millipore provides technologies, tools, and services for bioscience research and biopharmaceutical manufacturing.
The FDA has expanded Titan Spine's (Mequon, Wisconsin) Endoskelton TA vertebral body replacement device (VBR) 510(k) to include an Interbody fusion device indication. The Endoskeleton TA is approved for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Endoskelton TA is a titanium cage that sits on the strongest portion of the lumbar endplate, yielding excellent resistance to subsidence and expulsion. Coupled with a large open area for bone graft, the device's acid-etched titanium surface serves to provide a strong press fit and boney ingrowth.