Medtronic rolls out a new spinal prosthesis device and gains FDA clearance for an anterior cervical plate system.
Medtronic (NYSE:MDT) said it gained 510(k) clearance for 1 spinal repair device and began the commercial rollout of another.
The FDA grants 510(k) clearance to Medtronic for its Euphora semicompliant balloon dilation catheter for coronary stenting procedures.
Medtronic (NYSE:MDT) today said the FDA cleared its Euphora semicompliant balloon dilation catheter, and the company wasted no time in getting the pre-stenting device on the U.S. market.
Medtronic says the FDA expanded the indication for its StealthStation surgical navigation tool to include cranial and ENT procedures in children and adults.
Here's a look at some of the top legal news stories for medical device companies this week: Witness for J&J's Synthes faked credentials; Medtronic agrees to stop making SynchroMed drug pump; NuVasive settles Justice Dept. probe for $14m; Boston Scientific inks $119m pelvic mesh deal; Stryker inks $3m settlement in Howmedica reimbursement suit
, Centers for Medicare and Medicaid Services (CMS)
, Dept. of Health & Human Services (HHS)
, Dept. of Justice (DOJ)
, DePuy Synthes Spine
, Food & Drug Administration (FDA)
, Globus Medical
, Howmedica Osteonics Corp.
, Johnson & Johnson
A new analysis of more than 1,200 patients treated with Medtronic's Endurant AAA stent graft showed 'strong results' in short- and standard-neck abdominal aortic aneurysms.
Medtronic says it's launching a clinical trial evaluating renal denervation and cardiac ablation in treating atrial fibrillation.
Medtronic (NYSE:MDT) today said it's launching a study of a new, combination treatment for atrial fibrillation using renal denervation and cardiac ablation.
Here's a look at some of the top regulatory stories for medical device companies this week: FDA panel issues aneurysm device recommendations; Burr introduces fast-track FDA bill; Medtronic wins EU approval for MRI-safe Activa DBS devices; FDA approves Siemens 3D breast tomo device; Maquet's TigerPaw II recall is Class I