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Considerations for Mobile Health Technology Developers: Part 2

pharmaphorum

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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FDA launches Digital Health Center of Excellence

pharmaphorum

Housed within the agency’s Center for Devices and Radiological Health, the DHCoE is part of a wider strategy to encourage development of digital health products and therapeutics. Its remit will be to support and encourage developers, including newcomers to healthcare, to translate new technology into usable products.

Radiology 144
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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

Radiology 119
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Finalizing the Quality Management System Regulation – A High Priority for End of 2023

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda. According to the Unified Agenda, the proposed rule is in the final rule stage.

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Patient Safety and Radiopharmaceuticals Administration: Minimizing Radiation Exposure and Risks

Worldwide Clinical Trials

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. Pregnancy : Radiation exposure during pregnancy can potentially harm the developing fetus.

Hormones 130
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MIOTIFY platform for digital health products clears AZ road test

pharmaphorum

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well.

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FDA grants swift approval to Cognoa’s digital device for autism diagnosis

pharmaphorum

The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval. “The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” he added.

Doctors 114