Devices

Gottlieb Touts Digital Health Approach

FDA commissioner Scott Gottlieb says the agency’s approach to digital health isn’t to regulate the everyday health and lifestyle uses of consumer devices, but rather to focus its resources on reviewing more sophisticated medical apps that sit on top of the general purpose hardware — the functions that have greater ramifications for patient health and where ensuring safety and efficacy of the application is critical. In a statement, he says the goal is to encourage greater innovation in digital health, including using artificial intelligence and clinical decision support software.

“We believe that a modern, flexible, risk-based approach to regulation will reduce time and cost of market entry, assure patient safeguards are in place, and encourage more developers,” he writes. “This includes innovators that are new to healthcare. We want to give more entrepreneurs a chance to translate digital advanced into tools that can help benefit patients.”

Gottlieb reviews several agency efforts and then says FDA is seeking additional resources in the FY 2019 budget, including funding for a Center of Excellence for Digital Health that would advance the pre-certification model for digital health and modernize the agency’s regulatory approach to help the industry grow and reach its full potential.

“As we advance digital health tools to improve patient care,” he says, “we’re also modernizing our approach to making sure these products are safe. A significant area of concern remains cybersecurity. FDA is taking a lead role in medical device cybersecurity to address an unmet gap in the healthcare and public sector. Cybersecurity requires a multi-disciplinary focused team to bring together a range of requisite experience to fully address and validate high-risk/high-impact vulnerabilities and incidents, including potential patient safety implications. FDA will leverage this new public-private entity to complement the efforts of the agency’s cybersecurity unit and other government efforts.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome