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Cardiogenesis, an Irvine, CA-based medical device company that specializes in devices that stimulate cardiac angiogenesis, submitted a PMA last week for its minimally invasive Robotic 5.0 PEARL Delivery System. The PEARL, which stands for Port Enabled Angina Relief, uses Cardiogenesis’ Transmyocardial Revascularization technology to deliver precise bursts of Holmium:YAG laser energy to an area of ischemic myocardium. During a typical procedure, approximately 20-35 channels are made in the heart muscle. These channels promote the growth of new blood vessels, which provide the damaged heart tissue a better supply of blood and oxygen. The PEARL System is designed to operate through a 5.0…

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An article published today by Nanowerk says that today’s hefty investments in nanotechnology come with risk. Nanotech applied to diagnostics has raised hopes that diagnosis will eventually be possible at the cellular and sub-cellular levels. The article says that quantum dots are responsible for taking cellular imaging to a whole new level: “In recent years, scientists have discovered that these nanocrystals can enable researchers to study cell processes at the level of a single molecule. This may significantly improve the diagnosis and treatment of cancers. Fluorescent semiconductor quantum dots are proving to be extremely beneficial for medical applications, such as…

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Life sciences startups are popping up — and looking for money — in the Research Triangle Park section of North Carolina, says an article from today’s The News & Observer. “At least 10 life-science companies, most of them based in the Triangle, have started to look for their first round of investment, making them what is considered early-stage companies,” reports the paper, adding, “That’s more entrepreneurial activity than in any of the past eight years.” In particular, the area has seen an increase in the number of medical device firms because they often produce a quicker return on investment than pharmaceutical…

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Yesterday’s New York Times had a special section — a “user’s guide” — on diagnostic testing. It covers asthma, bone disease, cancer, heart disease, obesity, diabetes, AIDS and glaucoma. Don’t have time to read it? Here’s what you need to know. The section on asthma says there’s still no gold-standard test. “There are no easy markers or a single blood test to tell when it’s asthma and when it’s not,” a family-practice physician tells the Times, which notes that unlike for many other conditions, with asthma, “doctors often rely more on family histories and thorough questioning about symptoms and exposure…

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Results released today from a study of a new test for prostate cancer have raised spirits in the medical community and at the private Seattle firm that discovered it. Onconome’s blood test measures EPCA-2 (Early Prostate Cancer Antigen), a newly discovered blood protein that when elevated, appears to indicate the presence of prostate cancer. In this latest study, published in Urology, Onconome’s test correctly identified 94 percent of men with prostate cancer and 97 percent without. By way of contrast, with PSA (prostate-specific antigen) tests, the current standard detection method, 80 percent of patients with elevated PSA levels do not have prostate cancer and 15…

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Biomoda, an Albuquerque, NM, maker of cancer diagnostics, announced today that it has hired Synergestic Marketing to help “accelerate licensing development and sales relationships with customers domestically and worldwide,” according to Biomoda’s president, John Cousins. Synergestic’s president, Mark Lutvak, said his firm, which tends to focus on med tech divisions of much larger companies (divisions of Fujitsu, American Airlines and Hitachi are clients), was impressed by Biomoda’s joint work with Mayo Clinic. Mayo Clinic and Biomoda have agreed to jointly conduct a broad validation study of Biomoda’s patented technology, a non-invasive cytology based lung cancer diagnostic assay. The technology is based on a…

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NeoGenomics, a Fort Meyers, FL-based lab that specializes in cancer diagnostic testing, announced on Wednesday that it was teaming up with protein biomarker maker Power3 Medical Products to form a joint venture contract research organization. The purpose of the CRO is to develop blood serum-based diagnostic tests around the protein biomarkers identified by Power3 (there currently are 523). Power3 has agreed to license to the CRO all of its intellectual property on a non-exclusive basis for selected commercial applications, as well as provide certain management personnel. For NeoGenomics’s part, it will provide access to cancer samples, management, sales and marketing personnel,…

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Three venture-backed medical device firms raised more than $400 million through IPOs last quarter, Red Herring reports. Topping the list of money makers was Sunnyvale, CA-based Accuray, maker of the CyberKnife Robotic Radiosurgery System for treating tumors throughout the body with minimal damage to the surrounding tissue. The company’s February 8 debut included underwriters JP Morgan, UBS, Piper Jaffray & Co., and Jefferies & Co., according to the Associated Press. And Venture Capital Access Online notes, “Venture investors in Accuray include Marubeni Corporation and several undisclosed funds.” The offering, which raised some $288 million, culminated in a recent $1.2 billion…

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