Medical Device and Diagnostic Industry (MD+DI)

FDA Clarifies When Software & Wellness Products Are Not Medical Devices

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory classifications.
RAPS

Medical Device Validation: What You Need to Know and Why It's Important

Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...
News Medical

The Role of Process Validation in Ensuring Consistent Drug Quality

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
Business Wire

Sware Raises $6M to Accelerate Life Sciences Innovation by Automating FDA-Mandated Software Validation

BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...
Nature

Not all AI health tools with regulatory authorization are clinically validated

Devices that lack adequate clinical validation pose risks for patient care. A new validation standard is proposed to evaluate FDA authorization as an indication of clinical effectiveness in medical AI ...
RAPS

Inadequate Medical Device Validation a Common Problem RAPS Publishes 'How-to' Resource

Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device ...
JD Supra

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...
Medical Xpress

Almost half of FDA-approved AI medical devices are not trained on real patient data, research reveals

Artificial intelligence (AI) has practically limitless applications in health care, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...
Newswire

LIGHT AI ANNOUNCES INITIATION OF FDA PIVOTAL CLINICAL TRIAL FOR QUICKSCAN™ STREP A SOFTWARE AS A MEDICAL DEVICE (SaMD)

Ethics Committee Approval Received for Pivotal Study Intended to Support U.S. FDA Class II Submission for QuickScan™ Strep A VANCOUVER, BC, June 4, 2026 /CNW/ - Light AI Inc. ("Light AI" or the ...
JD Supra

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care ...
EurekAlert!

Almost half of FDA-approved AI medical devices are not trained on real patient data

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...