Ultrasound AI Receives FDA De Novo Clearance for Delivery Date AI Technology
Cloud-based SaMD (Software as a Medical Device) designed to assist healthcare providers in predicting delivery date using ultrasound imaging
Tag Archives: SaMD
FDA-Cleared SaMD by the Numbers
Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which companies are having the most success getting their products cleared for the U.S. market.
Navigating Global Regulations for SaMD
Decoding the legal framework for faster time-to-market.
Unlocking Success in SaMD Product Launches Through AI
AI-driven regulatory platforms support SaMD organizations by proactively monitoring and adapting to the dynamic global regulatory landscape. The technology alerts users to anticipated regulatory updates worldwide, facilitating improved foresight and trend detection. It also provides guidance on addressing potential lapses in product compliance, integrates with existing workflows and streamlines regulatory tasks from classification to registration and market entry.
Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance
This week Huma Therapeutics received FDA Class II 510(k) clearance for its Software as a Medical Device (SaMD) platform, potentially speeding approval of a variety of AI and machine-learning (ML)-powered digital health devices. We spoke with Kaushik Gune, U.S. Head of Healthcare at Huma, about the current state of digital health technologies, the value of partnerships to enhance the use of real world data and how digital health is likely to advance in the coming years.
Software and Artificial Intelligence as a Medical Device
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
AI/ML-based SaMD: Trends in Litigation
This pioneering area of technology comes with new risks and questions of liability.
The Regulatory Aspects of AI/ML-based SaMD
Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.
Patent and Regulatory Challenges in AI’s Use in Life Sciences
With the rapid growth of life tech discoveries, there is a need to adapt the patent and regulatory frameworks governing the approval, use, and protection of such discoveries.
Software as a Medical Device Draft Guidance Aims for Global Harmonization
FDA offers help on when and what type of clinical evaluation is appropriate for SaMD.