AI Detection System, Critical Limb Ischemia Device Gain FDA 'Breakthrough' Status
Executive Summary
Two companies disclosed Breakthrough Device designations from US FDA on Jan. 29, one for an artificial intelligence tool for detecting intracranial hemorrhage, and the other for a system to treat critical limb ischemia.
You may also be interested in...
LimFlow On Target For 2021 US Launch Of Deep Vein Arterialization System
The results from the PROMISE I feasibility study give LimFlow confidence that the PROMISE II pivotal trial will prove that the LimFlow percutaneous deep vein arterialization system is a safe and effective alternative to amputation for patients with critical limb ischemia.
'Breakthrough' Blueprint: US FDA Draft Guideline Outlines Revised Expedited Development Program
The Breakthrough Devices Program is the established Expedited Access Pathway with some statutory updates, including the addition of 510(k)-pathway devices. But FDA also uses the congressionally-mandated draft guidelines to outline some new features in the program that are not in the statute, including a process for "breakthrough device sprint discussions."
FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks
The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.