Less than 18 months since submitting the first part of a modular PMA, the VenaSeal varicose vein treatment system has now gained FDA PMA approval
Covidien
Deal Done: Medtronic and Covidien Are One
Medtronic plc says that it has successfully completed the previously announced acquisition of Covidien plc
Spectranetics will Benefit from CE Marking of Covidien’s Peripheral Artery DCB
Covidien plc has gained CE Mark approval for its Stellarex™ drug-coated angioplasty balloon which will be sold to Spectranetics when the Medtronic deal goes through.
Covidien’s PILLCAM® SB Capsule Endoscope Featured in New Smithsonian Exhibit
Innovative design of wireless, vitamin-sized capsule recognized for its profound impact on improving the standard-of-care for small bowel examinations
Covidien Unblocks AV Access Market with FDA Clearance of Fortrex™ PTA Balloon
Covidien plc has gained U.S. FDA 510(k) clearance for its Fortrex™ over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter.
CE Mark for the Covidien’s Latest Nellcor™ Bedside SpO2 Monitoring System
CE Mark approval for Nellcor™ PM100N Bedside SpO2 Patient Monitoring System brings the latest in bedside pulse oximetry to the home healthcare.
98.9% Vessel Closure at Six Months in VenaSeal™ Study
Covidien’s acquisition of Sapheon this summer is looking like a smart move as pivotal clinical study results at 6 months suggest it successfully treats symptomatic varicose veins.
FDA Clears Covidien HawkOne™ Directional Atherectomy System for Peripheral Arterial Disease
Covidien says the HawkOne™ System strengthens its directional atherectomy platform with a versatile solution for the treatment of peripheral arterial disease.
Spectranetics to Acquire Stellarex™ Drug Coated Balloon Assets from Covidien
Spectranetics is to acquire Covidien’s Stellarex™ drug coated angioplasty balloon platform in a move that is likely to be part of the plan to meet anti-trust conditions related to next year’s takeover by Medtronic.
Covidien’s Next Generation SuperDimension™ Speeds Lung Cancer Diagnosis
Covidien’s updated software features a more intuitive interface that helps reduce planning time and enhances airway visualization.
Covidien Sponsors American LUNG FORCE Initiative in Cancer Awareness Drive
Covidien supports publicity initiative to drive earlier diagnosis of lung cancer, opening up treatment options and improved patient outcomes
Covidien Gets Preliminary Injunction against Ethicon’s Harmonic ACE®+7
A new injunction issued by a US district court, prevents Ethicon from manufacturing, marketing and selling the Harmonic ACE®+7.
FDA Clears Covidien’s Nellcor™ Portable SpO2 Patient Monitoring System
Covidien’s newly cleared Nellcor™ Portable SpO2 Patient Monitoring System (PM10N) system is the only commercially available portable oximeter that is equipped with home care and sleep study modes.
Covidien Expands US Sonicision™ Range Following FDA Clearance
Covidien plc says its Sonicision™ Cordless Ultrasonic Dissection Device portfolio extends to 13 cm, 26 cm, and 48 cm device lengths following U.S. FDA 510(k) clearance.
New Trials Underscore Covidien’s Neurovascular Intentions
Covidien has announced the start of enrollment in two clinical trials that it says further underscores the safety and effectiveness of the company’s advanced neurovascular solutions.
Covidien Sales Up, But Pelvic Mesh Provision Clobbers Income
Sales ramped 4% compared with the equivalent period a year ago, but an increase in estimates of costs from pelvic mesh products liability cases saw S,G&A expenses ramp.