Archive for January, 2012

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InterVapor Endoscopic Thermal Ablative Treatment for Emphysema Gets CE Mark

InterVapor, from Uptake Medical (Tustin, CA), is a non-surgical endoscopic lung volume reduction procedure that uses thermal ablation without leaving foreign materials in the lung. In clinical studies of patients with severe emphysema, InterVapor has demonstrated clinically meaningful improvements in breathing function, exercise capacity and quality of life. The company has now closed a Series...

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Electronic Inhaler Nicotine Replacement Therapy for Smoking Cessation

Electronic Inhaler Nicotine Replacement Therapy for Smoking Cessation

Electronic cigarettes have become a big business as many smokers have opted to choose them over the traditional variety. Lack of actual smoke and tar is a major positive, but being able to “smoke” them even where smoking is not allowed may lead to a greater overall intake of nicotine. Nevertheless, many people bought...

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Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery

Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery

Medtronic received FDA 510(k) clearance to market its Aquamantys SBS 5.0 Sheathed Bipolar Sealer for sealing soft tissue and epidural veins during spinal surgery. The device delivers RF energy for cauterization and saline to keep the area clean and clear for easy access around sensitive tissue. From the press release: The SBS 5.0 Sheathed...

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FDA and Stanford to work together on med-tech education

Stanford’s decade old biodesign program is partnering up with FDA Center for Devices and Radiological Health to help the agency adapt the way it screens new medical technologies. The parties have reached a “memorandum of understanding,” rather than a formal agreement to specific projects, but the framework creates a method by which cooperation can...

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Roswell Park Launches Landmark Immunotherapy Vaccine Trial

Roswell Park Launches Landmark Immunotherapy Vaccine Trial

The Center for Immunotherapy at Roswell Park Cancer Institute (RPCI) is about to begin a very exciting new cancer clinical trial that will test a personalized immunotherapy to attack cancer cells. The new NY-ESO-1 dendritic cell vaccine will be produced “using a unique FDA-approved process — making RPCI the first research facility in the...

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Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System

Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System

Digirad received the European CE Mark of approval for its Cardius X-ACT solid state SPECT imager. It features low dose volume CT attenuation correction, 3D-OSEM reconstruction and upright imaging capability. The company already has approval from the FDA to market the Cardius X-ACT in the U.S. POWAY, CA – (MARKET WIRE) – 01/25/12 – Digirad Corporation (NASDAQ: DRAD) today...

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Solve Puzzles for Science

Solve Puzzles for Science

Players of the online protein folding game Foldithave reached another milestone, creating an 18-fold-more-active version of a model enzyme. The gamers worked on an enzyme that catalyses the Diels-Alder reaction, which is used in the synthesis of various chemical products (according to Wikipedia it is considered the “Mona Lisa” of reactions in organic chemistry). In...

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Crux Biomedical’s IVC Filter Receives CE Mark Approval

Crux Biomedical’s IVC Filter Receives CE Mark Approval

Crux Biomedical has received CE mark approval for its inferior vena cava filter (IVCF) with bi-directional retrieval. Inferior vena cava filters are implanted to trap blood clots that may cause pulmonary embolism in patients who are at high risk but have contraindications to anticoagulation. The Crux Biomedical IVCF was designed to overcome several limitations...

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DuoFertility Decodes Messages Between Armpit, Ovaries

DuoFertility Decodes Messages Between Armpit, Ovaries

Cambridge Temperature Concepts Ltd. received 510(k) approval for their DuoFertility ovulation Monitor. The DuoFertility monitor has been featured previously onMedgadget and comprises a wearable sensor and reader unit for measuring ovulation patterns. The sensor is worn under the armpit and measures subtle changes in basal body temperature which is indicative of ovulation. The reader wirelessly...

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Kaiser Permanente Health Records Securely Available on Mobile Devices

Kaiser Permanente Health Records Securely Available on Mobile Devices

Kaiser Permanente, the largest managed care organization in the United States, has unveiled an Android app and mobile-optimized website through which its 9 million patients can access their own medical information anywhere in the world on their mobile devices. The app and mobile website contain the same information and possibilities that were already available through kp.org, i.e....

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