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The FDA's Center for Devices and Radiological Health has extended its pilot
program for evaluating globally harmonized medical device premarket applications,
accepting submissions in this format until July 2006.
NeuroMetrix, a medical device company focused on the design, development and
sale of proprietary products used to diagnose neuropathies, announced it named
Brad Smith to serve as its chief financial officer, effective Feb. 14.
NovaBone Products has announced that results of an independent clinical study
of 20 spine fusion surgery patients showed that the company's FDA-cleared synthetic
bone graft product, NovaBone, stimulated new bone formation on an "equivalent
basis" compared to "BMP-2" (bone morphogenic protein) when each
was used in a composite.
Patient safety will drive the use of the next generation of active-RFID (radio
frequency identification) location tags from Radianse, an innovator of indoor
positioning solutions used to locate and associate equipment and people in hospitals.
CryoLife, a biomaterials and biosurgical device company, has entered into a
credit agreement with Wells Fargo Foothill, part of Wells Fargo & Company,
providing for a revolving credit facility in an aggregate amount equal to the
lesser of $15 million or a specified borrowing base.
MatrixOne has announced that LifeScan Scotland, which makes blood glucose monitors
for diabetics, selected MatrixOne's product life cycle management technology
to accelerate product development and time-to-market.
West Pharmaceutical Services, a maker of closure
systems and syringe components for use with injectable drugs, has announced
that, effective Feb. 8, it completed the sale of a substantial majority interest
in its drug delivery business to Archimedes Pharma, a new UK-based European
specialty pharma company backed by Warburg Pincus.