Minnesota’s CSI raises $5M for arterial plaque-removing device

Cardiovascular Systems Inc. (CSI), based in New Brighton, Minnesota, has raised $5 million from the sale of debt, according to documents filed with the Securities and Exchange Commission. In 2008, CSI filed an initial public offering (IPO), hoping to raise $86.3 million to help expand sales of its Diamondback 360 device, which removes plaque from peripheral vessels in the pelvis or leg.

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SurModics’ maneuvers may force Ramius to get hostile or drop out

Your move, Ramius. The alternative investment firm and activist shareholder purchased a 12 percent stake in SurModics Inc. (NASDAQ:SRDX) because it saw a clear opportunity to boost the stock and turn a nice profit. In its quest to name three people to the SurModics board, Ramius said it did not want to break up the company or replace the board. That may no longer be the case.

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Elk Run developer CEO gets medieval on MedCity News

When you’re the president and CEO of a major national real estate development firm, it’s best to develop a thick skin. It’s also probably not a good idea to post public comments to a news website when you’re pissed off at 1 o’clock in the morning. Yet that’s exactly what Steve Marks, CEO of Tower Investments in California did upon reading my story Tuesday on the troubled Elk Run BioBusiness Park his company is developing in Pine Island, Minnesota.

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Plot thickens: SurModics names CEO, puts pharma unit up for sale

I guess SurModics Inc. (NASDAQ:SRDX) just responded. Just a day after the company based in Eden Prairie, Minnesota, said it would formally respond to Ramius LLC’s efforts to name three people to its board of directors, SurModics announced late Tuesday it had named a new CEO and would explore a sale of its pharmaceuticals business.

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Will God save the Elk Run BioBusiness Park project in Minnesota?

“There are two things that we know about the universe,” Abraham Algadi said. “We can only control the things we can control. The rest, we leave to a higher power.” Algadi is not a priest or philosopher, at least professionally. Algadi, the city administrator for Pine Island, Minnesota, was referring to the fate of the much maligned, often delayed Elk Run BioBusiness Park.

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Medtronic wins FDA approval for diabetes management software

The artificial pancreas just got a brain. Medtronic Inc. (NYSE:MDT) said Monday the Food and Drug Administration has approved software that helps manage a patient’s diabetes therapy.

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SurModics silent on investment firm’s nominees to board of directors

As proxy fights go, the battle for SurModics Inc. (NASDAQ:SRDX), based in Eden Prairie, is downright tame — for now. Last week, Ramius LLC, the alternative investment firm of Cowen & Co. that recently purchased a 12 percent stake in SurModics, named its three candidates to the board of directors. While Ramius strongly criticized SurModics’ performance of late, the firm told shareholders it only seeks to “help,” not usurp the board.

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Top House Republican targets orthopedics industry, med devices

For those people in the beleaguered medical device industry who think they will fare better under a more Republican Congress, think again. As the industry and its allies in the U.S. Senate try to mitigate the Food and Drug Administration’s plans to tighten the 510(k) program, the incoming Republican chairman of a powerful House investigatory committee is taking aim at medical devices.

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Medtronic’s Sprint Fidelis settlement leaves some patients out in the cold

From a strictly legal sense, Medtronic Inc. (NYSE:MDT) has closed the book on its Sprint Fidelis debacle. The Fridley, Minnesota, company won a landmark victory in the U.S. Supreme Court that effectively shields medical device makers from liability of Food and Drug Administration-approved devices. And in October, Medtronic said it would pay $268 million to settle all lawsuits relating to its Sprint Fidelis leads. But about 260,000 Sprint Fidelis leads have been implanted in patients in the United States, with 143,000 still active.

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Minnesota senators recruit buddies to pressure FDA over 510(k)

Minnesota Sens. Amy Klobuchar and Al Franken along with Rep. Erik Paulsen have championed the medical device industry, giving speech after speech and writing letter after letter to the Food and Drug Administration about upcoming changes to its 510(k) approval program. I doubted the campaign would do much. But Wednesday, a bipartisan group of 15 senators sent a letter to FDA Commissioner Dr. Margaret Hamburg urging her agency, among other things, to adopt a more deliberate, cautious approach to amending 510(k).

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