Artificial Intelligence, Machine Learning, Diagnostic Tests

AdvaMed, Releases AI White Paper

Akin Gump Strauss Hauer & Feld LLP on 11/26/2024

AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more

Artificial Intelligence - The Promise of Early Disease Diagnosis and Improved Treatment and the Potential of Liability

Womble Bond Dickinson on 4/14/2023

If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more

AI and Cancer Diagnostics

Knobbe Martens on 9/13/2022

Rather than simply reading radiological scans, Ibex Medical Analytics is employing its artificial intelligence (AI)-powered cancer detection solutions to assist pathologists in the lab. Ibex’s Galen Platform is a...more

Potential AI/ML Learnings to Come from FDA Public Advisory Committee Meeting on Skin Lesion Analyzer Technology in Late July

Goodwin on 6/22/2022

On July 28, 2022, the U.S. Food and Drug Administration (FDA) will hold a public advisory committee meeting to discuss skin lesion analyzer (SLA) technology and its application to detecting skin cancers in various patient...more

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on 3/11/2021

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

AI Predicts Aggressiveness of Early Stage Breast Cancer

Womble Bond Dickinson on 10/28/2020

Approximately 20% of new breast cancers are diagnosed before they have spread from milk ducts into surrounding breast tissue. Breast cancer at this early stage is known as ductal carcinoma in situ (DCIS) or stage 0 breast...more