machine learning Archives - Medical Innovation Exchange

FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices

Leave a Comment / Ai-enable devices, artificial intelligence, Digital Health, digital therapetics, draft guidance, machine learning, Medical Device, MedTech, personalized medicine, Quality/Regulatory, RC - Medtech Regulatory Resource Center / By Inga Hansen

FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices On March 30, the FDA’s Center for Devices and Radiological Health (CDRH) published a draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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 Per the FDA’s announcement, the draft guidance …

FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices Read More »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

Leave a Comment / AFDO, AI, connected care, connectivity, data, Digital Health, From The Editor's Desk, Hologic, machine learning, Manufacturing Execution, Medical Device, MedTech, Orthogonal, Product Design & Development, regulation, Vicarious Surgical / By Inga Hansen

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 »

Instilling Trust in AI

Leave a Comment / adversity training, AI, biased data, Digital Health, facial recognition, John Kopkins, loss functions, machine learning, Medical Device, MedTech, Product Design & Development, sensors, wearables / By Inga Hansen

Instilling Trust in AI Artificial intelligence (AI) has become one of the most exciting and promising technologies in health care and MedTech, thanks to its ability to shift through huge volumes of data and quickly detect patterns. As commercial applications for AI continue to expand, questions have been raised regarding privacy, bias and even …

Instilling Trust in AI Read More »

From Art to Science: How Machine Learning Is Changing the Surgical Landscape

Leave a Comment / AI, augmented reality, Digital Health, digital twins, Focus Article, machine learning, Medical Device, MedTech, or, robotic surgery, Senhance, surgical simulation / By Inga Hansen

From Art to Science: How Machine Learning Is Changing the Surgical Landscape Robotic surgery has already proven its value in improving surgical outcomes. The next frontier is using data collection and artificial intelligence to help guide surgeons in the OR and develop surgical simulators that can expand and enhance training opportunities. We spoke with …

From Art to Science: How Machine Learning Is Changing the Surgical Landscape Read More »

Bridging the Design Development and Quality Management Chasm

Leave a Comment / AI, design development, machine learning, Medical Device, MedTech, PLM, Product Design & Development, quality management, supply chain / By Inga Hansen

Bridging the Design Development and Quality Management Chasm Catching potential quality and supply chain issues early in the medical device development process can save organizations significant amounts of money. However, current protocols and systems can inhibit sharing of information between departments at the earliest stages of development. We spoke with Tim Brown, Vice President …

Bridging the Design Development and Quality Management Chasm Read More »

Raising the Bar on Quality for MedTech Production

Leave a Comment / data sources, inregaretd data platform, IT, machine learning, manufacturing, MEDdesign, Medical Device, MedTech, OT, predictive quality, Product Design & Development, Sponsored Content / By Inga Hansen

Raising the Bar on Quality for MedTech Production Quality is a cornerstone in the production of medical devices. It is fundamental to the success of a business and to the patients that use the devices. Yet, traditionally, it is also one of the biggest cost overheads for manufacturers. The way we approach quality, however, …

Raising the Bar on Quality for MedTech Production Read More »

Empowering Patients Through RPM

Leave a Comment / 5G, AI, alarm fatigue, broadband, connectivity, Digital Health, Focus Article, machine learning, Medical Device, MedTech, remote patient monitoring, Soapbox / By Inga Hansen

Empowering Patients Through RPM As more and more healthcare activities take place from home, continuous monitoring solutions—including those that can track a patient’s status overnight—and new technologies, such as artificial intelligence (AI) will be critical to support communications between providers and patients. Solutions that offer continuous and passive monitoring will play a critical role …

Empowering Patients Through RPM Read More »

MedLance

E-Learning

Moderators

machine learning

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

Connected Care: Overcoming Roadblocks and Identifying Opportunities

Instilling Trust in AI

From Art to Science: How Machine Learning Is Changing the Surgical Landscape

Bridging the Design Development and Quality Management Chasm

Raising the Bar on Quality for MedTech Production

Empowering Patients Through RPM

Quick links

MedTech Minds

FDA Courses

Forum
News

About

Contact

Newsletter

Quick Links