It seems as if Escalon Medical (Wayne, Pennsylvania) has hit the proverbial jackpot for FDA product clearances lately.

The diagnostics device developer reported three such approvals in the last six weeks – with the latest being its VascuView Visual Ultrasound system – a portable device used to aid in visualizing vascular access procedures, developed by subsidiary Escalon Vascular Access (Wayne).

“Currently the device is approved for sale in the United States only,” Michael O’Donnell president of Escalon Vascular Access, told Diagnostics & Imaging Week via email. “We plan on expanding with CE marking soon.”

He added that the clearance of the VascuView system is a “very promising milestone as it not only reflects the successful culmination of our research and development efforts but represents our third FDA market clearance in the last six weeks. We remain committed to meeting the needs of the clinical community by delivering innovative and cost-effective technologies.”

Escalon’s Trek (New Berlin, Wisconsin), Drew Scientific (Wayne) and Sonomed (Lake Success, New York) subsidiaries also have received recent product marketing clearances from the FDA.

Plans call for Escalon Vascular to start shipments of the VascuView system immediately.

The VascuView uses a tablet PC, with software built on the Microsoft Windows XP platform. The probe itself contains the ultrasound circuitry and connects via a USB-2 interface. The device itself resembles a flat screen monitor with a probe resembling an elongated pen.

It includes a large image display touted by the company as providing easy visualization of targeted vessels and surrounding anatomy. The device also has scan operation controls on the probe itself allowing for maintenance of sterile fields.

The device has visualization of depth to 6 cm and software tools that include calipers for measuring vessel size and needle guide overlay to provide direction to the intended vessel.

The company says that the screen resolution provides precise clarity that will give physicians an edge in viewing scanned parts of the human anatomy.

O’Donnell said that “the timing of the VascuView introduction is key, as clinicians continue to adopt the use of ultrasound as a standard of care and techniques for vascular access to ensure efficacy and reduce complications. The addition of the VascuView Visual Ultrasound System to our existing PD Access and SmartNeedle Doppler Ultrasound Guided Needles, allows Escalon Vascular Access to offer a complete product line for assisted vascular access needs.”

“Escalon Vascular is always looking at expanding its product line in assisted vascular access,” O’Donnell said. “This is clearly demonstrated by our history and the recent FDA clearances of Escalon Vascular and its sister companies.”

The VascuView FDA clearance follows two clearances last year, one from Drew Scientific, for its D3 Hematology system, the other from its Sonomed subsidiary for the Master-VU ophthalmic B-scan ultrasound system.

Features of Drew’s D3 hematology analyzer include low reagent consumption and very small sample size to minimize laboratory waste, a built-in color touch screen, providing on-screen histograms and storage of up to 500 records and QC statistics, and multi-language capability.

Drew specializes in the design, manufacture and distribution of instruments for blood cell counting and blood analysis.

Sonomed’s Master-VU system consists of a B-scan probe that can be interfaced to a standard personal computer (via a USB cable connection) using the company’s software, thereby converting the personal computer into an ophthalmic ultrasound system.

Sonomed manufactures ophthalmic ultrasound diagnostic devices.

Besides moving out into the market its lion’s share of devices last year, Escalon also saw an end to an ongoing dispute with LASIK surgery device provider IntraLase (Irvine, California), over royalty payments for Escalon’s intellectual laser properties.

IntraLase ended up paying Escalon $9.6 million to settle the suit.

In April 2005, Escalon, which had been a holder of the common stock of IntraLase, demanded to inspect certain of IntraLase’s records, suspecting the withholding of royalties. IntraLase rejected the demand, Escalon said.

The settlement also marks the end of any future royalty payments to be received under the license agreement, expected to have a material effect on earnings in subsequent periods, partially offset by the elimination of legal fees related to this matter.

Escalon develops ophthalmic diagnostic, surgical and pharma products as well as vascular access devices.