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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 califfDigital health centerUs congressSoftware precertification pilot programNational evaluation systemDrug administrationMachine learningMedical devices workshopCurrent medical deviceFederal foodCosmetic actDifferent regulatory pathwayWithout legislation authorizingNew 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 califfDigital health centerHealth care viewpointsUs congressNational evaluation systemDrug administrationSoftware precertification pilot programMachine learningMedical devices workshopCurrent medical deviceFederal foodCosmetic actDifferent regulatory pathwayWithout legislation authorizingNew 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 statesSoftware precertification pilot programHarvest bioKnox healthAmerican college of physiciansAmerican academy of sleep medicineNox health groupDrug administrationClick therapeutics incPear therapeuticsAmerican academySleep medicineAmerican collegeInsomnia severity index

Pear Considers Acquisition, Sale, Merger, or Other Alternatives

Pear Considers Acquisition, Sale, Merger, or Other Alternatives
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Pear therapeutics incSoftware precertification pilot programHealth partnersPear therapeuticsPrecertification pilot

Pear Therapeutics Announces Process Exploring Strategic Alternatives

Pear Therapeutics Announces Process Exploring Strategic Alternatives
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