Since October, read more >>
June 23rd, 2008
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Boston Scientific said it will sell off pieces of its investment portfolio in two separate deals to help reduce debt it took on when it acquired Guidant, reports the Boston Globe. The deals are expected to raise about $140 million, but will also trigger a loss against second-quarter results. In the first deal, the firm will sell off its stake in 54 companies to Saints Capital, which buys venture-capital and private-equity investments, for $100 million. In the second deal, the firm will sell its investment in a portfolio of venture funds and companies to Paul Capital Partners, a private equity firm, for about $40 million. These moves come in addition to those announced earlier, including selling off non-core businesses and laying off employees. Big device companies can be a source of investment capital for start-up device companies. So start-ups shouldn'...
June 20th, 2008
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FDA has approved a device that allows some spinal cord-injury patients to breathe for up to four hours a day without a ventilator. The NeuRx DPS RA/4 Respiratory Stimulation System is an implantable electronic device that works by stimulating the diaphragm. The diaphragm, a muscle located in the lower abdomen, is essential for breathing, but some paralyzed patients may not be able to control it. The NeuRx, made by Synapse Biomedical, consists of four electrodes implanted in the muscle of the diaphragm that electronically stimulate contraction. It was approved on a Humanitarian Device Exemption, as it is not expected to be used on more than 4000 patients per year.
June 19th, 2008
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A Canadian study has found that doctors are denying candidates (and possibly weaker patients) for joint replacement surgery simply because they might lack access to treatments for recovery like home care or rehab services. Other pressures on physicians in Canada include long waiting lists and limited access to operating rooms. According to the study, which was published in the journal Medical Decision Making, some Canadian doctors didn't refer patients on the grounds that they couldn't get rehab treatment. This also raises a problem for older patients who are more frail. The healthcare system will need to address this issue soon, as the demand for joint replacements continues to rise.
June 18th, 2008
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Chattem Inc., maker of Icy Hot heat therapy patches, has received a warning letter from FDA because of failure to provide the agency with information, Reuters reports. Following 168 complaints, the firm changed wording on the product's label to help users avoid burns and irritations. It also issued a recall in February. But the letter said the company did not tell the agency about the changes, nor did it include child-specific recommendations on the product label. More on this topic will appear in the August issue of MD&DI.
June 17th, 2008
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It is not enough for medical device companies to have a compliance program relating to physician payments and perks. It is up to each company to demonstrate evidence that the program actually works, a consultant told those at the Medical Device Manufacturers Association meeting on June 13. Michael D. Bell, managing member of R-Squared, a compliance consulting firm, said that members of Congress and state legislatures are extremely focused on transparency and disclosure in the healthcare industry right now. And government litigators have gotten more aggressive in targeting companies who have questionable relationships with doctors. There may be as many as 100 investigations in progress, in fact. When firms have been caught, they have been forced to take measures that ensure future arrangements do not violate anti-kickback laws, he added. They have been told to create databases of all arrangements, track remuneration closely, and track...
June 16th, 2008
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Design and engineering are hugely important functions -- but their labors won't bear much fruit if their work can't be translated into the manufacturing environment. Johnson...
June 16th, 2008
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CDRH's new interactive review scheme is intended to prevent unnecessary delays in the completion of PMA and 510(k) reviews, Office of Device Evaluation director Donna-Bea Tillman said at a recent conference. It was also established to avoid surprises at the end of the review process, minimize the number of review cycles, and ensure timely responses from sponsors, she told those attending the Medical Device Manufacturers Association annual meeting on June 12. While informal dialogue has always been a part of the review process, it is now institutionalized, she said. An industry complaint about the MDUFMA review goals followed from 2002 to 2007 was that the scheme did not give reviewers enough time or flexibility to interact informally with applicants. The new scheme allows FDA to interact informally with applicants to resolve outstanding issues in a timely manner, Tillman said. For 510(k)s, it can pertain to any outstanding issues. For PMAs, it pertains to issues that can be resolved...
June 16th, 2008
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A test created by Harbinger Medical Inc. (Eden Prairie, MN) aims to predict the risk of a patient's mortality, which also might indicate (or rule out) the need for an ICD. In a study performed by a Mayo Clinic cardiologist, the Wedensky Modulation Index predicted 80% of the life-threatening irregular heartbeats from patients who already had already suffered heart attacks, according to the Star Tribune. The system uses low-voltage electricity to stimulate the heart and compares the heartbeat to a healthy heart. Here's the difference--a heart in good condition will have a dramatic response to stimulation, and a diseased heart that is experiencing an arrythmia has little response. Harbinger, a start-up company, wants to market the test by next year but hasn't received Medicare reimbursement yet. The test, which will cost between $200 and $300, could lead to lower ICD sales...
June 13th, 2008
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At least that's one possibility that researchers have in mind as they're tweaking the device. The researchers, from the University of Massachusetts Amherst, have given the robotic arm (manufactured by Barrett Technologies) the gift of vision via a digital camera. Although it's not possible just yet, Dov Katz, a doctoral student of computer science at Amherst, tells MD...
June 12th, 2008
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