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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. Lloyd Minor, Dean of the Stanford University School of Medicine discusses both the potential promise of increasing use of AI in healthcare settings (e.g.,

Radiology 119
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Long Time Passing: Where Have All the De Novo Decision Summaries Gone?

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process.

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DiME digital measure is nocturnal scratch for atopic dermatitis

pharmaphorum

The Digital Medicine Society (DiME) is today releasing a new set of open-access resources to advance the use of nocturnal scratch in the treatment of atopic dermatitis (AD). .

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Power to the Patient with Patient Generated Health Data

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

FDA Law Blog

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.

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Four ways Biogen is tackling digital innovation in neurological disease

pharmaphorum

It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. AI gets us closer to personalised medicine.”. In 2019, he was awarded “Excellence in Medical Affairs Award” by the Association of Pharmaceutical Medicine Singapore (APMS).

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FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

The Pharma Data

director of the FDA’s Center for Devices and Radiological Health. “We An FDA investigator’s list of examination compliances doesn’t constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its enforcing regulations. Source link: [link].