A new study in The New England Journal of Medicine found that a modest insurance co-pay was enough to deter many older women from getting potentially life-saving mammograms. The study examined 366,475 women between the ages of 65 to 69 enrolled at 174 Medicare managed-care plans. Screening rates were 8.3% lower for women whose plans required a co-payment (versus women whose plans covered the entire cost). Co-pays averaged $20, but ranged from $12.50 to $35. During the four-year study, the number of plans requiring co-pays rose 10%, from three plans in 2001 to 21 in 2004. Mammography has been shown…
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In February 2003, the FDA’s General and Plastic Surgery Devices Advisory Committee met and discussed thermal ablation of lung tumors. Concerns were raised about the safety and adverse event reporting associated with Radio Frequency ablation (RFA) of lung tumors. Last week, the FDA released a Public Health Notification, specifically warning against lung tumor ablation using RFA. Pointing to several studies, the statement noted, “[The] FDA has received reports of patient deaths associated with lung tumor ablation using RF ablation devices…Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities.”…
FlexmiR Select, a new assay designed by Luminex, will allow researchers to improve their analysis of microRNAs (miRNA) – single-stranded RNA molecules which regulate gene expression. FlexmiR Select allows researchers to create customized miRNA panels for more focused miRNA analysis. More than 200 microRNAs have been identified in humans, though the precise function of these regulatory, non-coding RNAs remains largely obscure. Some studies have linked miRNAs with cancer and heart disease. Patrick Balthrop, President and CEO, of Luminex believes the next step in microRNA research will be more concentrated analyses of small sets of miRNAs, “FlexmiR Select is the ideal…
A recent study conducted by Dr. Allan Siperstein and colleagues at the Cleveland Clinic presented three and five year survival data following radiofrequency ablation of colorectal liver metastases. As Siperstein noted in his paper, colorectal cancer is the third most common cause of cancer death in men and women, resulting in more than 53,000 deaths in 2007. The report showed 3-year and 5-year survival rates of 20.2% and 18.4%, respectively. The study was based on a prospective evaluation of 234 patients with colorectal liver metastases who underwent 292 RFA sessions between 1997 and 2006. The patients in this study were…
Tactile Systems Technology, a Minneapolis, MN, company whose technology treats vascular disorders such as lymphedema, has raised $11.8 million. The financing, led by Galen Partners of Stamford, CT, will be used to increase sales of the company’s lead product, Flexitouch, within the lymphedema market, and to expand into the chronic-wound space. The Flexitouch system consists of a programmable controller that attaches to segmented garments covering the limb, trunk and chest. Therapy is delivered through chambers in the garments that inflate and deflate sequentially, simulating manual lymphatic drainage. This at-home therapy usually follows manual lymphatic therapy provided by therapists in clinical…
Diamics, a Novato, CA, diagnostics company, has received CE Mark approval for a molecular-based cervical cancer-screening tool designed to improve the effectiveness of traditional testing methods. The Pap-Map System — which uses Diamics’ FDA-approved CerCol Cervical Cancer Collection System, for collecting cellular and fractional histological material from the entire cervix with a single, soft-tipped device — provides a “map” of collected cervical material. The system helps guide physicians’ diagnoses and decisions about subsequent colposcopy and biopsy procedures. Diamics says the system delivers more accurate, localized and definitive information than that provided by traditional screening methods. The company claims it reduces…
Ikonisys, a New Haven, CT, company that makes cell-based diagnostics for women’s health and oncology, has closed $30 million in Series E funding. The financing follows FDA clearance of two diagnostic applications for use in conjunction with Ikonisys’ Ikoniscope digital microscopy platform. The Ikoniscope is a fully automated microscopy platform that provides walk-away functionality, enabling real-time scanning and preliminary analysis of slide samples. Based on Ikonisys’ CellOptics technology, which fuses cell and molecular biology, microscopy, artificial intelligence and informatics, the Ikoniscope supports the automation of existing tests and Ikonisys’ own rare-cell detection tests. The company anticipates releasing the first two…
Imalux, a Cleveland, OH-based firm specializing in imaging technology, has closed a Series C round of $5.1 million, including conversion of $2.5 million of bridge financing. The funding — for which lead investors Early Stage Partners, ElectroSonics Medical, Reservoir Venture Partners, and Symark were joined by more than 20 existing and new investors — will be used to advance Imalux’s Niris Imaging System. The Niris System, FDA approved since 2004, is a point-of-care, desktop computer-sized device that allows physicians to view abnormal tissues in real-time. It uses near infrared light and a miniaturized lateral scanning mechanism inside a thin probe…