One of the FDA device center’s top priorities for its fiscal year 2025 is a draft guidance on lifecycle management and premarket submission recommendations for AI-enabled device software functions.

Since 2016, the Food and Drug Administration has received about 300 drug submissions that reference artificial intelligence, ...

Much of the conversation about medical device cybersecurity focuses on the new Food and Drug Administration’s (FDA) revised rules for premarket submissions. These regulations changed how devices ...

DALLAS - Spectral AI, Inc. (NASDAQ:MDAI), a Dallas-based artificial intelligence company specializing in medical ... company's planned submission for U.S. Food and Drug Administration (FDA ...

For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical ...

Movano (MOVE) plans to submit updated responses next week to all clarifying questions that it recently received from the FDA as part ... is a wearable device designed to provide medical device ...

In a major shift, most tests designed by individual labs for in-house use must meet Food and Drug Administration requirements for medical devices ... our submissions to the FDA,” Siddon said.

Milestone Achievement Supports Planned FDA Submission of DeepView AI®-Burn in 2025DALLAS, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc.

NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today announced Food and Drug Administration (FDA) submission of three-year safety and ...

Labs can use this roadmap to operationalize compliance by prioritizing their most valuable LDTs for the first FDA submission milestone, which involves medical device reporting (MDR) requirements ...

Revenue Rose to $8.2 MillionCompany Reaffirms Timeline for Regulatory Submission to U.S. FDAQ3 2024 OverviewResearch & Development Revenue ...

DALLAS - Spectral AI ... medical diagnostics, announced today that it has completed the final clinical visits for its U.S. Burn Pivotal Study. This study is a significant step towards the company's ...