Results from the AVEIR DR i2i Investigational Device Exemption (IDE) study through three-months post-implant showed a 98.3% implant success rate for physicians and more than 97% of people had a successful atrio-ventricular synchrony, so that the upper and lower chamber were beating normally, despite different types of underlying slow heart rhythms.
When considering use cases and data classification methods for machine learning, image quality, power consumption and latency must be considered.
Pulvinar Neuro has received a $3 million dollar NIH grant to further its research on noninvasive transcranial alternating current stimulation for the treatment of depression.
The recently announced “Refuse to Accept Policy” signed into law under section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA more traction to encourage the medical device manufacturing industry to utilize software bills of materials that help to incorporate supply chain security. The ISA/IEC 62443 series of standards defines a secure product lifecycle process that can be adopted by medical device manufacturers to identify and manage the security risks of all external components used within the product.
Chris Fourment, MD, Senior Vice President, Clinical Strategy at Iterative Health, who specializes in structuring clinical trial programs, discusses the new FDA guidance on decentralized clinical trials, and how DCTs can help spur health and research equity.
Large sets of data are collected throughout the surgical continuum, but are chief medical officers and perioperative leaders able to use that data to drive clinical, operational, and financial improvements? Embracing data-driven surgery can help HCOs make use of their data to improve care, reduce costs and better manage staffing and workflow.
This week Huma Therapeutics received FDA Class II 510(k) clearance for its Software as a Medical Device (SaMD) platform, potentially speeding approval of a variety of AI and machine-learning (ML)-powered digital health devices. We spoke with Kaushik Gune, U.S. Head of Healthcare at Huma, about the current state of digital health technologies, the value of partnerships to enhance the use of real world data and how digital health is likely to advance in the coming years.
“Content of Premarket Submissions for Device Software Functions” covers recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of safety and effectiveness of device software functions. The agency is hosting a webinar for industry on July 20 to provide an overview and answer questions about the new final guidance.
Not all use cases are good candidates for machine learning. In this column we look at cases where AI/ML may be appropriate and when building a traditional algorithm to solve a problem is a better choice.
When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more effectively. The following article outlines how companies can identify the appropriate degree of testing rigor for risk-based CSA validation to ensure the least burdensome approach.
