“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 ...
On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The ...
Medical device manufacturers have spent decades engineering products that save lives. Many are now discovering that their ...
In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...
Beyond Tariffs: The Software Supply Chain Risks Every Medical Device Manufacturer Should Be Watching
Headlines today obsess over tariffs squeezing margins for medical device manufacturers (MDMs). But while tariffs can shave profits, insecure software can obliterate them—and result in patient safety ...
Nathan Eddy works as an independent filmmaker and journalist based in Berlin, specializing in architecture, business technology and healthcare IT. He is a graduate of Northwestern University’s Medill ...
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 ...
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Propel Software, creator of the first product value management (PVM) platform that transforms how businesses create, market, sell, and service products, has ...
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 ...
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