Updated October 10, 2013, at 5 p.m. with comments from the CDRH panel.
CardioMEMS Inc.
St. Jude hits new Wall Street high ahead of FDA panel meeting
CardioMEMs’ 2nd chance with the FDA is good news for backer St. Jude Medical
Once-rejected CardioMEMs will get another shot at FDA approval for its Champion implantable heart failure monitoring systems when the agency’s Circulatory System Devices Panel convenes next month, according to a notice in the Federal Register.
MassDevice.com +7 | CMS targets med-tech, Infinity recall, Philips’ bribe charges, Joe DeVivo, iPhone glucose meter, TFX sells aerospace arm, CardioMEMS CEO on FDA ruling
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
MassDevice.com +3 | CardioMEMS CEO on FDA ruling, iPhone glucose meter, Stryker cuts 160 jobs
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com’s coverage highlights our three biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
UPDATE: CardioMEMS CEO on FDA’s Champion ruling
UPDATED Dec. 9, 2011, with comments from CardioMEMS CEO Dr. Jay Yadav, trial results
FDA panel thumbs down on CardioMEMS implantable heart monitor
An FDA advisory panel decided that CardioMEMS failed to prove that its wireless, implantable heart monitor’s benefits outweigh its risks, casting a shadow on a potential $375 million acquisition by St. Jude Medical (NYSE:STJ) – which already owns nearly a fifth of CardioMEMS.
FDA panel finds CardioMEMS device safe and effective, but questions clinical trials
An FDA review found CardioMEMS’ Champion heart failure pressure measurement system safe and effective, but questioned the logic of clinical trials supporting the device’s bid for pre-market approval.
While the company’s research met its goals, the watchdog agency raised questions about heart failure therapies that were administered by nurses during the clinical trials, potentially complicating the study as look at the value of the device alone.
Weight loss: GI Dynamics names new chief commercial officer, finance VP | Personnel Moves
GI Dynamics (ASX:GID) has a new global commercial head in Mark Twyman, who was appointed this week alongside Robert Solomon, who will be VP of finance.
Twyman will oversee international expansion of sales and marketing efforts for the Lexington, Mass.-based obesity and Type II diabetes treatment company’s flagship EndoBarrier device.
MDT and CardioMEMS win dates with the FDA
Medtronic Inc. (NYSE:MDT) and CardioMEMS have dates with the FDA.
The two med-tech companies will meet with the federal watchdog agency’s circulatory systems devices panel on Dec. 7 and 8 to discuss the future of their products.
St. Jude Medical to drop $60 million on CardioMEMS
St. Jude Medical Inc. (NYSE:STJ) agreed to spend $60 million on an equity stake in CardioMEMS Inc., an Atlanta-based medical device company that’s developing a wireless system to test heart function.
The deal gives St. Jude a 19 percent stake in CardioMEMS, plus an exclusive option to acquire the company for another $375 million "during the period that extends through the completion of certain commercialization milestones," according to a press release.