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Thoratec has said the FDA granted approval of its investigational device exemption
for the company to begin a Phase II pivotal clinical trial for the HeartMate
II LVAS (left ventricular assist system).
SpineVision has received FDA clearance to market its PediGuard instrument as
an FDA Class II device, making it the first and only FDA-cleared device for
real-time detection of possible penetration outside the vertebral pedicle, the
company said.
The University of Medicine and Dentistry of New Jersey has announced an expansion
in scope of the Carotid Revascularization Endarterectomy versus Stenting Trial
(CREST) study to include asymptomatic participants, and the addition of participating
trial sites from 70 to 110.
Lumenis, a global developer, manufacturer and seller of laser and light-based
devices for medical, aesthetic, ophthalmic, dental and veterinary applications,
reported that it has received a notification - referred to as a "Wells
Notice" -- from the staff of the Boston District Office of the SEC
in connection with the staff's ongoing investigation into various accounting
BioCardia announced the approval of its 510(k) application by the FDA for using
its Morph Universal Deflectable Guide Catheter in peripheral cardiovascular
surgical applications.
CoreValve announced that its proprietary percutaneous ReValving system, which
features a pericardium aortic heart valve mounted in a self-expanding frame,
has been implanted successfully for the first time in Europe in the cardiac
catheterization laboratory at the Heart Center, Siegburg, Germany.
Delphi Medical Systems, a subsidiary of Delphi, entered into a five-year agreement
with Cardinal Health to develop and manufacture respiratory devices for Cardinal
Health's Respiratory Care business.
Roche Diagnostics of Indianapolis, Ind., dismissed a complaint filed in U.S.
District Court, Southern District of Indiana against former supplier Access
Diabetic Supply of Pompano Beach, Fla.
Immunodiagnostic Systems bought the BoneTRAP diagnostic assay technology and
related assets of Finland's Suomen Bioanalytiikka Oy for a maximum of £1.5
million.
The Medical House, an orthopedic devices and drug delivery company, and BioPartners,
the global biopharmaceuticals company, announced a 10-year agreement for license
and supply of The Medical House's GH1 reusable, spring-powered, needle-free
delivery system for the delivery of BioPartners' human growth hormone product,
Valtropin.