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Cyberonics has submitted its response to the FDA warning letter dated Dec. 22,
2004, regarding nonconformities with current good manufacturing practice requirements
of the quality system regulation for medical devices, as specified in Title
21, Code of Federal Regulations, Part 820 during a meeting with the Dallas District
Office.
Endologix has announced that a clinical paper presented at the International
Symposium for Endovascular Therapy (ISET) suggests that three years following
treatment with the company's Powerlink System, patients (from the pivotal PMA
study) experienced decreases in aneurysm sac diameter and volume, and less angulation
of the aorta.
The market potential for products in the surgical securement field is driven
by a combination of new technologies coming to market and expanding application
caseloads.
Physicians from the University at Buffalo and Dent Neurologic Institute has
unveiled one of the first combined PET-CT scanners to begin operation in the
Buffalo area.
Edwards Lifesciences has announced the U.S. launch of its ThermaFix advanced
tissue treatment process, which will now be available on the company's Carpentier-Edwards
PERIMOUNT Magna replacement tissue heart valves.
A technique called molecular breast imaging (MBI) is highly sensitive in detecting
small lesions and can also spot tumors missed by mammography and ultrasound,
researchers report.
HealtheTech, which develops and markets handheld medical devices that measure
software metabolism and nutrition, filed with the SEC to deregister its common
stock under the Securities Exchange Act of 1934.
Third Wave Technologies has achieved ISO 13485:2003
certification, a stringent, globally recognized standard of quality management
for medical device manufacturers.