An 11-month clinical study generated positive results on Cook Medical's (Bloomington, Indiana) Biodesign Vaginal Erosion Repair Graft for the treatment of vaginal mesh exposures, a common complication resulting from the use of synthetic mesh in pelvic floor repair, the procedure used to treat pelvic organ prolapse. The Biodesign Vaginal Erosion Repair Graft reinforces the pelvic floor or vaginal wall and, over time, communicates with the patient's body, signalling surrounding tissue to grow across the scaffold where the pelvic floor needs to be repaired. Unlike synthetic mesh, Biodesign is resistant to infection, encapsulation and erosion into surrounding tissue.

• Deep Breeze (Manheim, Germany) said it received the CE mark for its O-Plan application extending the usefulness of the company's VRI technology to patients eligible for lung cancer resection. The application is now in use by thoracic surgeons in European Union countries. The O-Plan application replaces nuclear perfusion scans that are performed prior lung resections, with radiation-free VRIxp recordings. Deep Breeze has developed the O-plan specifically for thoracic surgeons. Together with VRIxp test and the O-Plan results, the surgeon can now with an improved accuracy predict the operability of patients with lung malignancies.

• eCardio Diagnostics (The Woodlands, Texas) has launched an Academic Medicine initiative to provide a tailored offering to university-based health systems. The eCardio Academic Medicine service offers: a web platform to address academic flow for patient management; 24-hour monitoring by eCardio's eLab, an independent diagnostic testing facility; and complimentary arrhythmia monitors, including extended monitors, cardiac event monitors and Holter monitors.

• Electro-Optical Sciences (Irvington, New York) said that additional data on MelaFind, the company's non-invasive, point-of-care instrument to assist in the early detection of melanoma, were presented at a symposium at the American Academy of Dermatology's recent annual meeting. MelaFind uses 10 different wavelengths of light to see where a clinician cannot — up to 2.5 millimeters below the skin's surface. Using advanced algorithms, trained and developed on a database of over 9,000 pigmented skin lesions and over 600 melanomas, including those from the pivotal study, the system is designed to provide information to assist in the management of the patient, including information useful in the decision of whether to biopsy the lesion.

• GE Healthcare (Wauwatosa, Wisconsin) reported the introduction of its latest ECG (electrocardiogram) solution, the portable MAC 800, based on cell phone technology. Targeting physician's offices and the pharmaceutical industry, GE's entry into the portable ECG market is as practical as it is innovative. MAC 800 has the features of a full size, 65-pound ECG device, engineered down to less than seven pounds, battery included. The unit's integrated carrying handle enables clinicians to carry it like a briefcase, expanding access to care, regardless of patient location, the company said. Its lithium ion battery keeps it running for roughly two hours and a quick, four-hour recharge ensures minimal downtime.

• HemAway (Berkeley Heights, New Jersey) reported the launch of the HemAway Seat, a painless, non-invasive, discreet, and easy-to-use hemorrhoid treatment device that alleviates the discomfort and agony of prolapsed internal hemorrhoids within minutes of use. Fitted for seamless and discreet installation on most toilet models, the HemAway Seat uses one's body weight to allow the prolapsed internal hemorrhoid to withdraw back into the body, relieving pain, discomfort, and irritation.

• Masimo (Irvine, California) said that a new clinical study demonstrates that Masimo PVI accurately and reliably reflects acute changes in intravascular fluid volume (preload). Assessing whether a patient needs fluid to increase their cardiac index (amount of blood the heart pumps each minute) is one of the biggest challenges anesthesiologists face during surgery. PVI is available as part of Masimo Rainbow SET Pulse CO-Oximetry a noninvasive patient monitoring platform that measures multiple blood constituents and helps to predict fluid responsiveness in patients previously requiring invasive procedures.

• Orbital Therapy (Bedford, Massachusetts) reported FDA clearance to market the ClearVue Prone Position Breast Radiotherapy Treatment Table in the U.S. ClearVue is a carbon fiber add-on treatment table used to simulate and treat breast cancer patients in the prone position. ClearVue can be used with existing CT simulators and linear accelerators to plan and deliver radiation treatments. Orbital Therapy's carbon fiber ClearVue prone position table was designed to address current and future requirements to deliver this promising therapy technique. As many studies begin to point to accelerated and partial breast radiation treatments, precise patient positioning and open access to the breast are becoming of greater importance.

• Prometheus Laboratories (San Diego) said it has received New York State approval for Prometheus IBS Diagnostic, the first and only blood test for irritable bowel syndrome (IBS). This novel test incorporates 10 biomarkers, two of which are proprietary, along with a proprietary algorithm to help physicians diagnose patients with IBS. The Prometheus IBS diagnostic testing is performed at the company's CLIA-certified laboratory in San Diego. Blood samples are collected and shipped overnight to Prometheus, after which test results are generally reported back to physicians within two to three days.

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