June 3, 2019. Artificial Intelligence/Machine Learning (AI/ML)-based software device that incorporates special computer techniques (algorithms) capable of detecting relevant medical patterns from large amounts of data. These very sophisticated pattern recognition capabilities (AI/ML) have broad potential healthcare applications, including making recommendations to healthcare providers and patients about the diagnosis, prognosis, treatment, or prevention of disease.1 The complexity, scalability, and broad scope of these new technologies thus raise important issues regarding their safety and effectiveness as it pertains to patients’ health.Read More »
May 31, 2019. The safety and effectiveness of new devices needs to be established before they are approved. Approval of products without this evidence puts patients at risk for unnecessary harm. Adequate and well-controlled clinical trials are the best way to establish that the benefits outweigh the risks for patients needing collagen-based hemostatic devices.Read More »
May 30, 2019. Thousands of adverse events associated with surgical staplers had been hidden from patients and physicians prior to the March 2019 Kaiser Health News expose. Such devices must be better regulated and monitored.Read More »
May 22, 2019. The 510(k) pathway system is flawed, and should be replaced with pathways that require controlled clinical trials for all implanted devices and many other devices as well. Meanwhile, safety can be improved with our recommendations.Read More »
May 16, 2019. The dietary supplement industry has made substantial progress in
weeding out bad actors since the “wild, wild West”, largely unregulated days of the mid-
1990’s. We support FDA’s recent efforts to crack down on manufacturers who make false or
misleading claims about their dietary supplements.