Category: Guided Therapeutics Inc.
Guided Therapeutics and the FDA agree on a plan to rework an approval bid for the medical device company's once-rejected LuViva cervical scanning system.
Guided Therapeutics (OTC:GTHP) made new progress on its once-rejected pre-market approval bid for the LuViva advanced cervical cancer scanning system, which the FDA knocked with a "not approvable" letter in January.
Guided Therapeutics wants an independent panel to review the pre-market approval application for its LuViva cervical scan, after the FDA issues a "not-approvable" letter, and files for CE Mark approval in the European Union.
Guided Therapeutics (OTC:GTHP) said it plans to ask an independent panel to review a pre-market approval application to the FDA for its LuViva advanced cervical scan after receiving a "not-approvable" letter from the agency.
The LuViva device scans the cervix with light to check for indicators of pre-cancer below the surface of the cervix. The federal watchdog agency wants additional clinical data on a newer version of the device, according to Guided Therapeutics president & CEO Mark Faupel.
Medtronic launches the Fire & Ice prospective trial to compare its Arctic Front cardiac cryoablation to Biosense Webster's Thermocool radiofrequency ablation system as a treatment for atrial fibrillation.
Medtronic's Arctic Force cryoablation system
Medtronic (NYSE:MDT) enrolled the first of up to 572 patients in its Fire & Ice trial, the largest clinical study to date to compare 2 atrial fibrillation ablation systems.
GE Healthcare invests in non-invasive continuous glucose monitoring with C8 Medisensors' light-spectroscopy device.
GE Healthcare (NYSE: GE) invested an undisclosed amount into C8 Medisensors, a developer of non-invasive continuous glucose monitors for diabetic patients.
C8 aims to provide glucose monitoring that is "painless, accurate, continuous, noninvasive, and nonintrusive to your life," according to its website.
The San Jose, Calif.-based company's glucose monitors use light spectroscopy to measure blood glucose levels without the need for frequent finger pricks.
Covidien beat Wall Street's expectations for both its fourth quarter and fiscal 2011 year, saying it expects 2012 sales to rise up to 5 percent; plus, American Shared Hospital's Q3 sales, profits surge; Athersys boosts Q3 sales, cuts losses; BSD Medical's FY2011 sales rise, losses decline; Cambridge Heart cuts Q3 losses; Q3 sales up, profits down for Dehaier Medical; Dynatronics' Q1 sales tick up, losses gape; Guided Therapeutics's Q3 sales surge, losses widen; HemaCare swings to Q3 profits; and InVivo Therapeutics posts a Q3 profit on derivatives gain.
Covidien (NYSE:COV) beat Wall Street's earnings expectations for both its fourth quarter and 2011 fiscal year, sending shares up 1.8 percent today.
The Mansfield, Mass.-based health care giant's medical device segment once again led the charge, posting an 18 percent sales increase for Q4 and 17 percent for the full year.
TriVascular lands FDA approval for its Ovation stent graft used to repair abdominal aneurysms in people with small arteries.
TriVascular Inc. landed U.S. humanitarian device exemption approval for its Ovation abdominal stent graft system used to repair abdominal aneurysms.
The 20 mm Ovation system was approved by the FDA on Nov. 1 for use in patients with small iliac or femoral artery access of less than 7 millimeters.