EP mapping (and the catheters that go with them) continues to be a hot topic in cardiac. St. Jude Medical adds an approved ablation catheter enabled to work with its prize hen, MediGuide Technology, the EP 3-D navigation platform that “allows physician to see the exact location and orientation of devices” inside a patient’s heart […]
On Wednesday, St. Jude Medical CEO Dan Starks fielded a couple of questions related to its Durata ICD lead on its fourth-quarter earnings call, although there were none on a possible recall of the product, despite my expectations. The Durata ICD lead has been troubled by its association with a recalled, previous-generation ICD lead and […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The shoe finally dropped. The U.S. Food and Drug Administration sent a warning letter to St. Jude Medical (NYSE:STJ) on Jan. 10 regarding its inadequate design validation process for the Durata ICD lead at the medical device firm’s Sylmar, California manufacturing plant. The warning letter was expected as the company’s CEO Dan Starks had already […]
St. Jude Medical (NYSE:STJ) announced Thursday that its board has authorized a $1 billion share repurchase program. The move shows that the board believes that the company’s stock is undervalued, but is likely to sway few who have lately punished the stock over concerns about St. Jude’s Durata ICD lead. Between Oct. 1 and Nov. […]
It’s not great when a company needs a rival to have a major disaster in order to see the upside, but when you are Boston Scientific (NYSE: BSX), it may be welcome news indeed. That is the queer situation Boston Scientific finds itself in at the close of a tough year. Or at least that […]
If St. Jude Medical (NYSE:STJ) executives were hoping for some respite from a slew of bad news during Thanksgiving, they did not get it. Reuters reported earlier Wednesday afternoon that shares of the Minnesota medical device manufacturer tumbled more than 13 percent on an inspection report from the Food and Drug Administration which found that […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
St. Jude Medical (NYSE:STJ) announced Monday that it has received CE Mark for its Portico transcatheter aortic valve system for patients who are deemed too sick to undergo open heart surgery to replace diseased heart valves. The medical device manufacturer has received clearance for the 23 mm Portico TAVI valve and St. Jude Medical describes […]
What do you do when the biggest market you play in continues to be weak, hospitals are buying less of your products, Europe, which used to be reliable, is now hobbled under austerity measures, and clinical trials don’t reach end points? You lay off workers, and a few months later you cut some more. That […]
As noted before, October has not been kind to St. Jude Medical. (NYSE:STJ). And now the Minnesota medical device maker has been hit with five back-to-back downgrades from equity analysts, including one issued by Morgan Stanley Analyst David Lewis on Monday. In his note, Lewis said that while the risks the company with its high […]
As U.S. markets have slowed with hospitals buying less, device makers have been looking toward overseas markets to bolster their revenue from cardiac rhythm management devices such as pacemakers and ICDs. But there may be new indication that those markets may not be as rock solid. Last week, St. Jude Medical (NYSE: STJ) reported its […]
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October has not been kind to St. Jude Medical (NYSE:STJ). On Wednesday, the company, apparently against all industry precedent, warned Wall Street of a possible warning letter from the U.S. Food and Drug Administration and saw its shares decline 6 percent. But earlier in October, it received communication from a key supplier that may have […]
Analyst Bob Hopkins of Bank of America was mystified and sounded a bit worried on the St. Jude Medical (NYSE:STJ) morning conference call to discuss the company’s third-quarter earnings Wednesday. St. Jude CEO Dan Starks had just done the unthinkable. He had warned investors that he was expecting a warning letter from the U.S. Food […]
St. Jude Medical (NYSE:STJ) announced Monday that it has launched a new 3D navigation system to evaluate heart and vascular anatomy on recorded fluroscopy images instead of a series of live X-Ray images, thus reducing the patient’s exposure to radiation during cardiac procedures. Called MediGuide Technology, it is the first and only 3D navigation system […]
St. Jude Medical (NYSE:STJ) announced Thursday that the Minnesota medical device maker has received European regulatory approval to market the Eon Mini Neurostimulator, the world’s smallest, implanted rechargeable device to treat chronic migraine. Along with this approval for the Eon Mini comes additional regulatory nods for the Eon and EonC neurostimulators. The Eon mini, which […]
On Thursday, St. Jude Medical (NYSE:STJ) announced that it was laying off 300 people and organizing its four businesses under two operating units. The move, the Minnesota medical device maker stated, was expected to save $50 million to $60 million in pre-tax operational expenses annually. Two analysts saw the layoffs as a measure to offset […]