FDA Breakthrough Device Designation
ArteraAI Prostate analyzes digital pathology images of a prostate cancer biopsy slide to help clinicians predict long-term outcomes.
The FDA clarifies its interpretation of "more effective," and indicates it will consider improved accessibility of a device during the Breakthrough designation process.
The news comes just as Pear is finalizing its SPAC merger.
With this designation, Swing is launching a real-world clinical trial to assess its fibromyalgia DTx.
Despite the prevalence and associated risks of postpartum depression, a significant portion of mothers never receive a diagnosis or treatment for the condition.