Medical Innovation Exchange

machine learning

Leveraging AI & ML in MedTech: Power Consumption and Latency

Leveraging AI & ML in MedTech: Power Consumption and Latency     In my last Artificial Intelligence (AI) column, we reviewed challenges that arise when there is either insufficient data to learn from, or when we have been supplied with data that has been intentionally pre-sorted in a way that prevents the Machine Learning (ML) algorithm …

Leveraging AI & ML in MedTech: Power Consumption and Latency Read More »

Data-driven Surgery: The Next Step in Improving Care and Operational Efficiency

Data-driven Surgery: The Next Step in Improving Care and Operational Efficiency     At every stage of surgery—preoperative, intraoperative, postoperative—data is collected. But if you don’t have strategies to provide surgical insights and intelligence, the data remains discrete, isolated, and of limited use. Data-driven surgery, based on the fast growing field of surgical data science (SDS), …

Data-driven Surgery: The Next Step in Improving Care and Operational Efficiency Read More »

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance     This week Huma Therapeutics received 510(k) clearance for its configurable Software as a Medical Device (SaMD) disease management platform, which previously received Class IIb approval in the EU. The FDA Class II clearance allows users to add AI algorithms to the disease-agnostic platform, potentially speeding …

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance Read More »

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence     The Association for the Advancement of Medical Instrumentation (AAMI) and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices. AAMI Technical Information Report (TIR)34971:2023, Application of ISO 14971 to machine …

AAMI and BSI Partner to Publish Guidance on Artificial Intelligence Read More »

Leveraging AI & ML in MedTech: Purpose-Built Applications

Leveraging AI & ML in MedTech: Purpose-Built Applications     A Venture Capitalist recently joked that to fund a startup, all one must do is choose a URL that ends in ‘.ai’. Although he was not serious, it was an acknowledgment that companies pursuing AI are getting much attention, and there is a fear of missing …

Leveraging AI & ML in MedTech: Purpose-Built Applications Read More »

FDA Offers Funding for Adoption of Advanced Manufacturing Technologies

FDA Offers Funding for Adoption of Advanced Manufacturing Technologies     Medical device manufacturers that are in the process of—or interested in—exploring advanced manufacturing technologies can receive funding from the FDA through the Advanced Manufacturing Clearing House (AMCH). The program, which is being run by the Medical Device Consortium (MDIC) in partnership with the FDA, provides …

FDA Offers Funding for Adoption of Advanced Manufacturing Technologies Read More »

FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing

FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing     On May 10, the FDA released two discussion papers on the use of artificial intelligence and machine learning (AI/ML) in drug development and manufacturing. In a statement introducing the papers, Patrizia Cavazzoni, M.D., Director of the FDA Center …

FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing Read More »

3M Health To Collaborate with Amazon To Accelerate AI in Clinical Documentation

3M Health To Collaborate with Amazon To Accelerate AI in Clinical Documentation     3M Health Information Systems (HIS) has announced a collaboration with Amazon Web Services (AWS) to accelerate the innovation and advancement of 3M M*Modal ambient intelligence. As part of the collaboration, 3M will use AWS Machine Learning (ML) and generative AI services, including …

3M Health To Collaborate with Amazon To Accelerate AI in Clinical Documentation Read More »

FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices

FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices     On March 30, the FDA’s Center for Devices and Radiological Health (CDRH) published a draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” Per the FDA’s announcement, the draft guidance …

FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices Read More »

Connected Care: Overcoming Roadblocks and Identifying Opportunities

Connected Care: Overcoming Roadblocks and Identifying Opportunities     What’s next—and what’s holding us back—on the road to a truly connected healthcare system? On March 14-15, leaders in digital health will come together at the ConnectedCare Summit East in Washington, DC, to look at best practices, pitfalls and what we’ve learned so far on the road …

Connected Care: Overcoming Roadblocks and Identifying Opportunities Read More »