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United States of America v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014), [1] was a decision in the United States Court of Appeals for the District of Columbia Circuit filed on February 4, 2014 concerning more than minimally manipulated cell therapies and whether they are considered part of medical practice or a drug, the latter subjecting it to regulation under the Food and Drug ...
Autologous conditioned serum, also known as Orthokine and Regenokine, is an experimental procedure in which a person's own blood is extracted, manipulated, and then reintroduced with claimed benefit in osteoarthritis. [1] There is limited evidence on safety and effectiveness as of 2017. [1] It is not included in medical guidelines as of 2017. [1]
Cost per procedure, sometimes known as price per procedure, is a medical pricing model which describes the average cost of receiving a certain medical procedure. [1]
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For scale, cutting administrative costs to peer country levels would represent roughly one-third to half the gap. A 2009 study from Price Waterhouse Coopers estimated $210 billion in savings from unnecessary billing and administrative costs, a figure that would be considerably higher in 2015 dollars. [50] Cost variation across hospital regions.
The device for carrying out the procedure was originally developed by a company called Curon which obtained FDA approval for the device in 2000 but then went bankrupt in 2006; the device was brought back to market by Mederi Therapeutics in 2010. [2] [6] The procedure costs between $3,000 and $4,000 as of 2004. [7]
It is an outpatient or office-based procedure. The equipment consists of a vapor generator and a transurethral delivery device. The latter is similar to a cystoscope with an optical system with a 90° extending retractable 10.25 mm long injection needle (diameter 1.3 mm). From this needle water vapor is circumferentially delivered via 12 holes ...