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SonoSite, a company specializing in hand-carried ultrasound, announced the worldwide
launch of its MicroMaxx ultrasound system, the company's third generation hand-carried
product.
AMI Semiconductor (AMIS), a designer and manufacturer of state-of-the-art integrated
mixed-signal and structured digital products, has announced a technology design
and supply partnership with Interventional Rhythm Management (IRM), the specialist
cardiology company dedicated to the management of patients with cardiac arrhythmias
and heart failure.
Summa Design, a contract design and development company focused on the medical
device industry, announced that Dudley Harris, a former regional director for
the FDA, has joined Summa Design as director of regulatory affairs and quality
systems.
Vascular Solutions announced that it has received 510(k) clearance by the FDA
for its ThrombiGel hemostatic foam, a new version of the company's original
D-Stat Dry product.
Kensey Nash announced the final results of the FIRST (First European Investigation
Regarding the Systematic use of the TriActiv Device) Study which was designed
to examine cost-effectiveness of the TriActiv System in saphenous vein graft
patients, to support reimbursement for the device in Germany and European countries.
Medtronic announced the beginning of enrollment in the PRESTIGE LP Cervical
Disc clinical trial, Medtronic's third major artificial cervical disc trial
designed to explore new technologies for the treatment of degenerative back
disease.
Cierra announces the successful treatment of the
first set of patients with their groundbreaking PFX Closure System for the treatment
and closure of Patent Foramen Ovale (PFO).
St. Jude Medical, a developer of devices to treat cardiovascular disease, said
that it received FDA approval for its QuickSite 1056T bipolar lead, a device
that aids stability and shortens procedure times in cardiac resynchronization
therapy (CRT) for heart failure patients.
Medtronic announced it received approval by the FDA to add sequential biventricular
pacing -- or ventricle-to-ventricle (V-V) timing -- to its InSync Sentry and InSync
Maximo cardiac resynchronization therapy defibrillators.
Integra LifeSciences Holdings plans to market and sell the AccuDrain External
CSF Drainage System -- an external ventricular and lumbar drainage system used
to drain cerebral spinal fluid (CSF) from patients who suffer from increased
cranial pressure due to trauma or surgery.