A new guidance document and a promise to hold a public workshop are just two commitments made by the US agency in a 12 January action plan aimed at AI/ML-based software as a medical device.
A new guidance document and a promise to hold a public workshop are just two commitments made by the US Food and Drug Administration in a new five-point action plan aimed at artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD).
The FDA says its action plan, released on 12 January, was developed based on input from stakeholders who responded...
About 30% of providers flagged cybersecurity and data privacy as concerns while 40% pointed to patient engagement platforms as a challenge. By contrast, only 10% of respondents viewed AI and Gen AI applications or critical system upgrades as urgent priorities.
The US FDA will hold a public meeting of its Digital Health Advisory Committee in November to focus on generative AI-enabled medical devices to treat mental health.
The American Medical Association says years of advocacy have resulted in Medicare policy changes that are a big win for physicians and patients.
A report from the HHS suggests using wearables and electronic health records to identify childhood chronic illness causes. It urges the FDA to expedite digital health device approvals while ensuring safety. The report also highlights the need for advisory panel and user fee transparency.
A report from the HHS suggests using wearables and electronic health records to identify childhood chronic illness causes. It urges the FDA to expedite digital health device approvals while ensuring safety. The report also highlights the need for advisory panel and user fee transparency.
Microbot wins FDA nod for Liberty, Medtronic’s Hugo showed positive results in hernia repair in clinical studies, Obvius Robotics reports first human procedure with CERTA, Ronovo closes a $67m financing round with JJDC, and Quantum expands Epione CE marking to bone tumors.
Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.
