Potential Breakthrough Treatment For Enlarged Prostate
A potential breakthrough treatment for patients with an enlarged prostate is attracting attention as studies begin to show a new interventional technique could be a very effective alternative to surgery. A minimally invasive procedure known as prostate artery embolization was one of the main subjects of an interventional radiology conference, where results of a study were recently released.
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Directed energy device-based medical therapies have greatly influenced the way physicians deliver care in a number of medical specialties. One of the most dramatic areas of change has been in the management of benign prostatic hyperplasia, commonly referred to as an enlarged prostate. DE treatments in this area have become so popular there has been a noticeable decline in once standard surgical therapies since the late 1990s as patients have migrated to these less-invasive alternatives. This expansion in BPH DE-based therapies is being driven not only by a shift toward less-invasive treatment options, but also by the rising number of patients susceptible to prostate ailments.
EURLs have been a critical missing element of the IVDR for assessing the higher-risk class D IVDs. Two new implementing regulations, on fees and tasks, bring them closer to designation.
It takes a lot of negotiation with regulators, advisory boards, and alignment between commercial and portfolio management teams to define and agree a clinical trial protocol. Why on earth would companies change it once a study is underway?