Criticare Systems (Milwaukee), which designs patient monitoring systems and non-invasive sensors for hospitals and other healthcare environments, reported the release of a new technology platform for non-invasive blood pressure (BP) measurement using a traditional BP cuff. The system adds a greater level of patient comfort, safety, accuracy, reading speed and tolerance of a range of physical and environmental conditions. Its gentler pressure feature addresses all patients, but in particular, reduces a potentially painful experience when used on children and the elderly. Criticare said it believes it is one of the first patient monitoring companies worldwide to adhere to both U.S. and European standards for validation of blood pressure measuring devices. The technology is now in production at Criticare and also will be offered on an OEM basis.
JMAR Technologies (San Diego) said it has been issued U.S. patent No. 6,845,145 B2 for advanced X-ray lithography stepper technology that will enable a faster, more cost-effective means of producing zone plate optics for its Compact X-ray Microscope and X-ray Nano Probe product lines. JMAR said the combination of its soft X-ray source and its newly patented stepper creates a "unique tool" for fabrication of the zone plate diffractive optics used to collect and focus X-rays.
Neoprobe (Dublin, Ohio) said the FDA has accepted its request to establish a corporate investigational new drug (IND) application for Lymphoseek. With the establishment of the corporate IND, responsibility for the clinical and commercial development of Lymphoseek has been officially transferred from the University of California, San Diego (UCSD) to Neoprobe. Lymphoseek is intended to be used in biopsy procedures for the detection of lymph nodes in a variety of tumor types including breast, mela-noma, prostate, gastric and colon cancers. In connection with the transfer of responsibility for the Lymphoseek IND from UCSD to Neoprobe, the FDA has provided guidance suggesting it be evaluated in a multi-center clinical study to confirm the findings observed by the UCSD researchers. That initial multi-center trial would then be followed by a confirmatory Phase III study using the final cGMP material. Neoprobe said it intends to commence enrollment in the first of the two multi-institutional studies as soon as the appropriate regulatory and institutional review board clearances are received.
Siemens Medical Solutions (Malvern, Pennsylvania) has received FDA 510(k) clearance for MammoReport(Plus), a mammography softcopy reporting workstation that Siemens showcased at the National Consortium of Breast Centers conference in Las Vegas. The clearance allows for the processing of digital computer-aided images and mammograms from approved vendors, expanded indications for multimodality viewing, and use with FDA-cleared monitors for the interpretation of lossless compressed images. In addition, MammoReport(Plus) is now Windows-based, which enables it to run on syngo, the intuitive software platform from Siemens that delivers powerful networking and post-processing capabilities. MammoReport(Plus) works in conjunction with Siemens' Mammomat Novation(DR) to provide a comprehensive system solution for clinical processes in mammography.
SmartPill Diagnostics (Buffalo, New York), developer of the SmartPill Capsule, a non-invasive, ingestible medical device that captures biomedical data from within the patient's GI tract, reported that 510(k) clinical trials of its SmartPill ACT-I Capsule and GI Monitoring System are under way at Massachusetts General Hospital (Boston). A total of 130 subjects and five clinical trial sites are expected to participate in 510(k) clinical trials of the SmartPill ACT-I Capsule and SmartPill GI Monitoring System. Of the 130 subjects, 70 are control and 60 are gastroparetic. Gastroparesis is one of the primary GI motility disorders in which the SmartPill ACT-I Capsule will aid diagnosis and management. Temple University Hospital (Philadelphia) will begin clinical trials next week, and three other sites will begin clinical trials shortly thereafter. The 510(k) clinical trials will be completed in May and will lead to 510(k) submission in June.