CDSCO issues draft guidelines to regulate medical device software

Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML ...
JD Supra

Software as a Medical Device: Challenges Facing the Industry

Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians ...
JD Supra

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission ...
MassDevice

FDA warns on J&J’s Abiomed Automated Impella Controllers after death reported with software error

The FDA issued an early alert to notify the public of a potentially high-risk issue with J&J's Abiomed Automated Impella ...
Medical Xpress

Revealing the landscape of software as a medical device industry

There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...
Forbes

FDA Medical Device Security SBOMs: While Great, Don’t Rely On Them Alone

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...
Healthcare IT News

AI-enabled medical devices may fail on real-world patients, report cautions

Unlike traditional software systems that rely on deterministic rules, artificial intelligence devices frequently use ...