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FDA Treatment of AI, Machine Learning Software as a Medical Devic

FDA Treatment of AI, Machine Learning Software as a Medical Devic
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Rob Califf , Digital Health Center , Us Congress , Software Precertification Pilot Program , National Evaluation System , Drug Administration , Machine Learning , Medical Devices Workshop , Current Medical Device , Federal Food , Cosmetic Act , Different Regulatory Pathway , Without Legislation Authorizing , New Regulatory ,

FDA Needs a New Approach to AI/ML-Enabled Medical Devices | Mintz - Health Care Viewpoints

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital. ....

Rob Califf , Digital Health Center , Health Care Viewpoints , Us Congress , National Evaluation System , Drug Administration , Software Precertification Pilot Program , Machine Learning , Medical Devices Workshop , Current Medical Device , Federal Food , Cosmetic Act , Different Regulatory Pathway , Without Legislation Authorizing , New Regulatory ,

Nox Buys Pear's Insomnia App for Nearly $4 Million at Auction

Nox Health is set to acquire Somryst, a prescription digital therapeutic for chronic insomnia treatment, from Pear Therapeutics. ....

United States , Software Precertification Pilot Program , Harvest Bio , Knox Health , American College Of Physicians , American Academy Of Sleep Medicine , Nox Health Group , Drug Administration , Click Therapeutics Inc , Pear Therapeutics , American Academy , Sleep Medicine , American College , Insomnia Severity Index ,

Pear Considers Acquisition, Sale, Merger, or Other Alternatives

Pear Considers Acquisition, Sale, Merger, or Other Alternatives
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Pear Therapeutics Inc , Software Precertification Pilot Program , Health Partners , Pear Therapeutics , Precertification Pilot ,

Pear Therapeutics Announces Process Exploring Strategic Alternatives

Pear Therapeutics Announces Process Exploring Strategic Alternatives
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Meara Murphy , Company Board Of Directors , Health Partners , Software Precertification Pilot Program , Exchange Commission , Pear Therapeutics Us Inc , Corporate Communications , Pear Therapeutics Inc , Pear Therapeutics , Precertification Pilot , Private Securities Litigation Reform Act ,