Eyenuk Inc. is significantly extending the scope of its artificial intelligence system for the automatic analysis of retinal images, adding the diagnosis of age-related macular degeneration (AMD) and glaucoma to the EU approved uses of Eyeart AI.
New York-based Paige.AI Inc., was successful in its de novo application to the U.S. FDA for the company’s digital pathology software for identification of cancerous prostate tissue, but the agency needed nearly a year and a half after the September 2021 grant of de novo petition to post the regulation for this novel algorithm.
The U.S. FDA inked a Dec. 20, 2022, warning letter to Righteye LLC that handed the company a list of quality system issues in dire need of redress, but the agency was more concerned about off-label promotion of the Righteye vision system as a method for evaluating the patient’s ocular tremors as a sign of Parkinson’s disease.
Ottawa-based start-up Realize Medical Inc. reported U.S. FDA clearance of virtual reality (VR) surgical planning software to help physicians create and share complex patient anatomy from CTs and MRIs in an immersive 3D environment. Company CEO Justin Sutherland told BioWorld clearance of the Elucis platform “is a crucial milestone” that will benefit hospitals and his company well into the future.
M.A. Medalliance SA has been awarded a de novo investigational device exemption (IDE) by the U.S. FDA for its sirolimus-eluting balloon. This approval is subject to initiation of a pivotal clinical trial in the U.S.
The advantage of the U.S. FDA’s effort to regulate artificial intelligence (AI) in medical devices is that it is specific to medical devices and other medical products, but this vertical approach to AI regulation might soon become exceptionally complicated thanks to a new AI risk management framework posted by the U.S. National Institute for Standards and Technology (NIST). The NIST guideline is agnostic to the sector of the economy and thus may carry with it the expectation that developers of software as a medical device will hew to both the NIST framework and FDA regulations, a layering of requirements that could vastly complicate the task of developing and deploying these algorithms.
Makers of medical devices and pharmaceuticals face a significant risk of product liability litigation, but the use of third-party funding of such lawsuits is a novelty in the U.S. relative to some other Western nations. Nonetheless, a new report by the U.S. Government Accountability Office (GAO) makes clear that third-party litigation funding is an increasing common practice that seeks to include uninjured parties in mass tort litigation, thus endangering the fortunes of those who invest in life science companies.
Four members of the U.S. Senate have inked a draft bill that would require the FDA and the Patent and Trademark Office (PTO) to set up a task force designed to improve communication between the two agencies. This would appear to replicate a bill introduced during the 117th Congress, but not ultimately passed, and there is little clarity this early in the legislative cycle as to the prospects for this latest iteration.
Makers of medical devices and pharmaceuticals face a significant risk of product liability litigation, but the use of third-party funding of such lawsuits is a novelty in the U.S. relative to some other Western nations. Nonetheless, a new report by the U.S. Government Accountability Office (GAO) makes clear that third-party litigation funding (TPLF) is an increasing common practice that seeks to include uninjured parties in mass tort litigation, thus endangering the fortunes of those who invest in life science companies.
The U.S. FDA has cleared a first-of-its-kind 4K single-use arthroscope developed by Pristine Surgical LLC to improve the efficiency, consistency, and safety of arthroscopic procedures. The single-use Summit surgical arthroscope is said to deliver a high-definition image using a simple set up and automated inventory management system for improved predictability and workflow.
