The Centers for Medicare and Medicaid Services have updated the criteria for hospitals and physicians to begin or continue providing transcatheter aortic valve replacement surgery. The decision gives hospitals and providers more flexibility to meet the CMS requirements for performing TAVR, the agency said Friday. The original National Coverage Determination (NCD) for TAVR procedures was cleared in […]
Medtronic
Medtronic readies $4B debt tender
Medtronic (NYSE:MDT) said today that it’s aiming to redeem more than $4 billion in senior debt in a pair of tender offers. The Fridley, Minn.-based medical device titan said the first tender is for up to $1.18 billion, consisting of $500 million in 4.125% senior notes due 2021 and $675 million in 3.125% senior notes […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices
Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]
Male ex-employee gets go-ahead to sue Medtronic for gender bias
A federal judge in Birmingham, Alabama has denied Medtronic’s attempt to throw out a sex discrimination lawsuit filed by a male former employee. The employee, Joshua Boyd, began working at Medtronic (NYSE:MDT) in 2013. Boyd claims that despite earning the title of “top seller” of surgical equipment for Medtronic’s Midwest region, a new female manager […]
ADA 2019: Hybrid closed-loop devices take center stage
The American Diabetes Association’s 79th Scientific Sessions is a five-day conference where researchers and healthcare professionals share the latest in diabetes research. More than 180 sessions and over 2,000 research presentations took place during the meeting on June 7-11 in San Francisco. During the meeting, diabetes experts shared data and research from clinical trials. Here are four […]
Medtronic hints at upcoming surgical robot
Medtronic (NYSE:MDT) won’t unveil its new robot-assisted surgery platform until the fall, but a recent announcement from the company offered a sneak peek at what’s coming. The medical device giant yesterday disclosed a partnership with Karl Storz SE & Co. (Tuttlingen, Germany) to use Karl Storz’s three-dimensional vision systems and visualization components into Medtronic’s upcoming robot-assisted […]
Medtronic, Tidepool ink deal for interoperable, automated insulin pump
Medtronic (NYSE:MDT) and nonprofit org Tidepool announced last week that the groups will work together to develop an interoperable, automated insulin delivery system. The medtech giant reported that it plans to build a Bluetooth-enabled MiniMed pump that is compatible with Tidepool’s Loop app, an open-source app for automated insulin delivery. Get the full story at our sister site, […]
Medtronic wins $150m radiology, imaging equipment DoD supply contract
Medtronic (NYSE:MDT) has won a maximum $150 million contract with the U.S. Dept. of Defense to supply it with radiology and imaging systems, according to a recent DoD release. Through the deal, the Fridley, Minn.-based medtech giant will supply the Army, Navy, Air Force, Marine Corps and associated federal civilian agencies with radiology and imaging systems, […]
Medtronic issues another recall for Endo GIA staplers
Medtronic (NYSE:MDT) has issued another select recall of its Endo GIA surgical staplers, this time for single use loading units, Tri-Staple 2.0 intelligent reloads and cartridges over potential missing components, the company said in a recently posted urgent field safety notice. The Fridley, Minn.-based company said it is voluntarily recalling the devices due to the potential […]
Checkpoint Surgical touts nerve monitor study results
Checkpoint Surgical today announced the results of a study that called its handheld nerve monitor a safe and reliable alternative to existing technology for neural monitoring during surgery. The retrospective study compared the use of the Cleveland, Ohio-based company’s Checkpoint nerve stimulator/locator to Medtronic’s nerve integrity monitor for vagal, recurrent and superior laryngeal nerve monitoring […]