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Escalon(R) Announces FDA 510(k) Clearance For Sonomed MASTER-VU(TM) B-Scan System
Escalon Medical Corp.
(Nasdaq Capital Market: ESMC) announced that its Sonomed, Inc.
subsidiary received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) to market the MASTER-VU(TM) ophthalmic B scan
ultrasound system. The MASTER-VU(TM) System consists of a B scan probe that
can be interfaced to a standard personal computer (via a USB cable
connection) using Sonomed's proprietary software, thereby converting the
personal computer into an ophthalmic ultrasound system. Sonomed plans to
commence shipments of the product in the United States immediately.
Barry Durante, Sonomed's President stated: "The FDA clearance, along
with the previously received CE certification, will allow Sonomed to market
this new breakthrough instrumentation worldwide. With computers becoming
standard in most ophthalmic physician offices, purchasing the probe and
software offers complete portability for use in multiple locations. Loading
the software in computers in multiple offices allows the physician to carry
only the probe from office to office. We expect that the MASTER-VU(TM) will
be a valuable addition to our product line in both the U.S. and
international marketplace."
The MASTER-VU(TM) System adds to Escalon's wide range of top quality
and market leading ultrasound systems. This flexible and easy-to-use
instrument offers simple installation, low maintenance and immediate user
productivity. The MASTER-VU features include:
-- Measurement calipers for multiple intraocular measurements.
-- Ability to save both 30-second "clips" as well as individual frames on
a scrolling frame manager.
-- On-screen annotation capability, including text and graphics.
-- Easy installation and low maintenance.
Sonomed, Inc. is a diagnostic ultrasound company specializing in the
design, manufacture and distribution of instruments for ophthalmology.
Sonomed is focused on providing quality instrumentation for ophthalmic
physicians' offices, clinics and hospitals.
Founded in 1987, Escalon develops markets and distributes ophthalmic
diagnostic, surgical and pharmaceutical products as well as vascular access
devices. Drew Scientific, which operates as a separate business unit,
provides instrumentation and consumables for the diagnosis and monitoring
of medical disorders in the areas of diabetes, cardiovascular diseases and
hematology, as well as veterinary hematology and blood chemistry. Escalon
seeks to utilize strategic partnerships to help finance its development
programs and is also seeking acquisitions to further diversify its product
line to achieve critical mass in sales and take better advantage of
Escalon's distribution capabilities, although any such partnerships or
acquisitions may not occur. Escalon has headquarters in Wayne, Pennsylvania
and manufacturing operations in Long Island, New York, New Berlin,
Wisconsin, Dallas, Texas, Waterbury, Connecticut and Barrow-in-Furness,
U.K.
This press release contains statements that are considered
forward- looking under the Private Securities Litigation Reform Act of
1995, including statements about Escalon's future prospects. They are based
on Escalon's current expectations and are subject to a number of
uncertainties and risks, and actual results may differ materially. The
uncertainties and risks include whether the Company is able to:
-- implement its growth and marketing strategies, improve upon the
operations of Escalon's business units, including the integration of
Drew's and MRP's operations, the reorganization of the Drew business
and the integration of any acquisitions Escalon may undertake, if any,
of which there can be no assurance
-- implement cost reductions
-- generate cash
-- identify, finance and enter into business relationships and
acquisitions.
Other factors include uncertainties and risks related to:
-- new product development, commercialization, manufacturing and market
acceptance of new products,
-- marketing acceptance of existing products in new markets
-- research and development activities, including failure to demonstrate
-- clinical efficacy
-- delays by regulatory authorities, scientific and technical advances by
Escalon or third parties
-- introduction of competitive products
-- third party reimbursement and physician training, and
-- general economic conditions.
Further information about these and other relevant risks and
uncertainties may be found in Escalon's report on Form 10- K, and its other
filings with the Securities and Exchange Commission, all of which are
available from the Commission as well as other sources.
Escalon Medical Corp.
http://www.sonomedinc.com
Escalon (R) Announces FDA 510 (k) Clearance Pentru Sonomed MASTER-Vu (TM), B-Sistem de scanare - Escalon(R) Announces FDA 510(k) Clearance For Sonomed MASTER-VU(TM) B-Scan System - articole medicale engleza - startsanatate