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 ...
RAPS

FDA finalizes brain-computer interface guidance, issues draft for glycemic control devices

The US Food and Drug Administration (FDA) has issued four medical device-related guidance documents. The new guidances address brain-computer interfaces, considerations in medical device design for ...
Forbes

The Evolution Of Medical Device Products In A Consumer-Driven World

Fueled by convenience, fashion, size and technical innovation, medical devices have evolved from clinical settings to daily consumer use. Today’s highly personalized devices are being embedded into ...
Nature

Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA’s De Novo pathway

Medical devices have played a critical role in raising the standards of healthcare delivery. The COVID-19 pandemic underscored clinical medicine’s dependence on devices ranging from diagnostic test ...
Los Angeles Times

The Life-or-Death Stakes of Medical Device Cybersecurity

Ransomware attacks on the healthcare sector surged by 30 percent in 2025, frequently disrupting operational technology and medical devices. FDA Section 524B mandates that manufacturers provide a ...
Nature

Open-source design of medical devices

There is a chronic need for medical devices for the diagnosis and treatment of patients in low- and middle-income countries (LMICs) 1. The current medical device market is not providing affordable ...
JD Supra

(Don’t Fear) the Regulator: FDA Clarifies When Software and Wellness Products Are Not Medical Devices

“Don’t fear the Reaper,” the rock band Blue Öyster Cult famously advised. For many digital health companies, the Food and Drug Administration’s recently revised guidances affecting the classification ...