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August 25, 2011 – ­ The Munich biotech company apceth started its first Phase I/II clinical study on somatic cell therapy for advanced peripheral arterial occlusive disease (pAOD) after angioplasty. The aim is to investigate the tolerability and efficacy of somatic cell therapeutics developed by apceth for the treatment of pAOD. The study is designed as an open, randomized, monocenter study with two parallel patient groups and is being conducted in cooperation with the Isar-Medizinzentrum in Munich. The first patients have already been treated. A total of 30 patients are to be recruited into the study by March 2012. The initial results of the study are expected by mid-2012.

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August 25, 2011 – The U.S. Food and Drug Administration (FDA) has released its list of pre-market approval (PMA) and 510(k) decisions for new or enhanced medical devices from June 2011. The list includes all FDA PMAs, product development protocols (PDP), supplement and notice decisions. This list is generated on a monthly basis.

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August 24, 2011 - The Joint Commission issued an alert today explaining ways to lower risks posed by ionizing radiation from imaging exams while maintaining diagnostic image quality. The Joint Commission said healthcare organizations can reduce risks due to avoidable diagnostic radiation by raising awareness among staff and patients of the increased risks associated with cumulative doses, by providing the right test and dose through effective processes and new technology.

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August 24, 2011 — Physio-Control Inc. announced commercial availability of the ReadyLink 12-lead electrocardiogram (ECG) device. It is a new U.S. Food and Drug Administration (FDA) 510(k)-cleared solution designed to improve care for heart attack patients and expand regional ST-segment elevated myocardial infarction (STEMI) systems.

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August 24, 2011 — The U.S. Department of Health and Human Services (HHS) announced a new initiative to improve care for patients while in the hospital and after discharge. Doctors, hospitals, and other healthcare providers can now apply for a new program known as the Bundled Payments for Care Improvement initiative (Bundled Payments initiative).

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August 24, 2011 -- Radiopharmaceuticals are pharmaceutical agents used to diagnose certain medical problems, such as cardiac, cancer or neurology, and/or treat certain conditions such as cancers. The use of radiopharmaceuticals as tracer dates back to 1930s.

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August 24, 2011 — CardioFocus Inc., developer of the HeartLight endoscopic ablation system (EAS) for the treatment of atrial fibrillation (AF), announced the system is now available in the United Kingdom. The first AF patients were treated at The Heart Hospital in London on Wednesday, August 17, with additional cases to take place throughout the month.

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August 24, 2011 — Cleveland HeartLab Inc. (CHL), a specialty clinical laboratory and disease management company, announced the completion of an $18.4-million Series B financing round. The rapidly growing company hopes to further accelerate market adoption of its advanced approach to assessing cardiovascular disease risk using biomarkers of inflammation. This approach includes the company’s CardioMPO test for circulating myeloperoxidase, the anchor of its proprietary inflammation panel.

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August 23, 2011 — Verathon Inc. introduced the Heartscape 3-D Electrocardiogram (ECG) System with 80-lead vest in Europe. It is designed to give emergency department (ED) physicians, interventional cardiologists and ED nurses a more complete diagnostic picture by providing a 360-degree view of the heart.

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August 23, 2011 — A new study shows heart attack patients are now being treated an average of 32 minutes faster than five years ago. This provides evidence a national campaign's success to treat heart attacks within 90 minutes in order to reduce heart damage and costs associated with treatment. This is according to David Holmes, M.D., FACC, president of the American College of Cardiology (ACC).

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August 23, 2011 — PLC Systems Inc. said the final results from the REMEDIAL II investigator-sponsored clinical trial have been published online in Circulation, a peer-reviewed journal of the American Heart Association. It will appear in the September 2011 issue of the publication. REMEDIAL II is an Italian trial of the company’s RenalGuard device.

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August 23, 2011 — nContact Inc. has received CE Mark approval for the EPi-Sense Guided Coagulation Device with VisiTrax for the treatment of cardiac arrhythmias, including atrial fibrillation (AF). The EPi-Sense features epicardial sensing electrodes designed to allow both electrophysiologists (EP) and cardiothoracic surgeons to map and navigate the epicardium and locate areas for linear epicardial ablation.

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August 23, 2011— UltraSPECT of Haifa, Israel, announced the sale of more than 10 of its wide beam reconstruction (WBR) software solutions to nuclear pharmaceutical supplier PCI for placement at customer medical facilities throughout Arizona. PCI is a member of United Pharmacy Partners Inc. (UPPI), a nuclear pharmacy network consortium that recently signed a multi-year distribution agreement for the leasing and/or non-exclusive sales of UltraSPECT’s cardiac and bone imaging applications in the United States.

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August 23, 2011 — Cardium Therapeutics received the final $1.1 million payment from Royal Philips Electronics in connection with Philips' acquisition of Innercool Therapies from Cardium. The purchase gives Philips Healthcare a therapeutic hypothermia product line for use in heart attack, sudden cardiac arrest and neuro trauma patients

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August 19, 2011 - Neovasc Inc. accomplished $4.7 million in financing to complete the COSIRA clinical trial for the Neovasc Reducer to treat refractory angina. The company will also advance the Tiara project to develop a transcatheter device to treat the mitral valve regurgitation.

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