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.

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.

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).