• Carl Zeiss Meditec(Dublin, California) reported commercial availability for its VISUCAMlite to capture digital images of the retina and posterior segment of the eye, which assists in the diagnosis and documentation of retinal diseases and glaucoma. The VISUCAMlite offers the capability to electronically capture and display photographs of the retina. Color, red-free and fluorescein angiography are the standard still-capture modes. VISUCAMlite also offers a black and white video capture feature. VISUCAMlite offers multiple ways to capture structural changes of the retina and posterior segment of the eye, providing a full-spectrum approach to diagnosis and documentation of retinal diseases and glaucoma. With advanced Zeiss optics, VISUCAMlite provides enhanced comfort for patients. The camera also provides maximum convenience for practices, as they are DICOM conformant and capable of exporting images in a variety formats via a practice’s network or the accompanying CD burner.

• Dade Behring (Deerfield, Illinois) reported that it has received FDA 510(k) clearance for the Emit II Plus Ecstasy Assay, the company’s rapid screening method for use in detecting the presence of ecstasy in human urine. The assay screens urine for methylenedioxymethamphetamine (MDMA, or Ecstasy), methylenedioxyethylamphetamine and methylenedioxyamphetamine. It complies with proposed SAMSHA (Substance Abuse and Mental Health Services Administration) and European regulations, and has approved applications for use on the Olympus AU400/ AU600/AU2700/AU5400 systems and the Syva 30R Analyzer. Availability on the Viva-E and V-Twin drug testing systems is expected in April, with other open chemistry systems to follow. The Emit II Plus Ecstasy Assay, Dade Behring’s newest addition to the Syva drugs-of-abuse testing menu, meets laboratory demand for an Ecstasy-specific test that includes a 500 ng/mL cutoff level, the company said. The new assay is intended to be used as a stand-alone test or in conjunction with the Emit II Plus Amphetamines Assay, which detects MDMA at higher levels than does this new Ecstasy-specific test. The Emit II Plus Ecstasy Assay is a convenient, ready-to-use liquid assay based on the “gold standard” Emit II Plus chemistry, and reagents are offered in two kit sizes to accommodate both low and high-volume laboratories.

• iMedica (Dallas), a developer of electronic health records solutions, was awarded U.S. patent No. 6,874,085B1 for the data security system used in its PhysicianSuite electronic medical record and the upcoming iMedica Patient Relationship Manager 2005. iMedica’s security design and method “ensure patient confidentiality while allowing patient medical records to be accessed over a network such as the Internet,” according to the patent. Through iMedica.NET, the company offers its clients secure, HIPAA-compliant data backup and “anytime, anywhere access” over an Internet connection. IMedica’s data storage technology ensures that its clients’ information is secure, safe and accessible. The PhysicianSuite EMR and iMedica Patient Relationship Manager 2005, which will be released this summer, both use iMedica’s data security design to provide reliable security along with anytime/anywhere access.

• Ortec International (New York), a tissue-engineering company, reported that it has been informed by the FDA that the agency has received all the information required for it to complete its review and arrive at its recommendation for Ortec’s premarket approval application for the treatment of venous ulcers. Ortec and the FDA agreed that the previous announced meeting scheduled to take place this month is no longer required. It is expected that the FDA will communicate its recommendation to Ortec within the next 30 days.

• W. L. Gore & Associates (Flagstaff, Arizona) said it has received FDA 510(k) clearance to market the Gore Bio-absorbable Hernia Plug. The device, the first of its kind, was developed as an alternative to permanent hernia plugs. The bioabsorbable properties of the device allow it to be completely absorbed naturally by the body as the hernia defect heals. The plug’s design optimizes repair time, while allowing the surgeon to quickly and easily tailor the device to fit the defect. The flexible, hollow tubes unique to the Bioabsorbable Hernia Plug fold and collapse, permitting the device to adapt to the cavity. Excess material can be trimmed away. In addition, the tubular construction serves as scaffolding for guided tissue regeneration. The plug is available with or without a permanent overlay mesh.