Devices

Digital Health Center of Excellence ‘Roadmap’ Explained

A 10/19 CDRH Webinar listening session explained the “roadmap” governing the new Digital Health Center of Excellence (DHCoE) and heard comments from stakeholders. DHCoE director Bakul Patel said the organization’s goal is to empower digital health stakeholders to advance healthcare. “We believe digital health has the potential to change healthcare to the next era,” he said.

Patel described digital health as a convergence of connectivity, data, and computing power for healthcare and its related use across the life of an individual or patient, moving healthcare from the clinical to the patient.

“We want to drive synergy,” Patel said. “We want to align strategy and implementation. And most importantly, we want to make sure that FDA and the community are prepared for the digital health future while protecting patients and maintaining our standards, our FDA standards of safety and effectiveness.”

Following comments from representatives of several stakeholder groups, CDRH director Jeffrey Shuren said that patients and consumers “should have digital health technologies that meet their needs and that they can rely on.” He said that patients, consumers, and providers need an FDA that empowers and educates them, and that actively listens to, understands, and incorporates their voices.

“Developers,” he said, “need an FDA that understands and advances and moves science and engages with developers and other stakeholders to provide advice proactively, not just feedback and problem-solve in real-time, and that offers predictable, transparent, consistent, robust but appropriately tailored regulatory pathways that optimally are globally harmonized.”

Shuren concluded that the DHCoE can serve as a leader, a facilitator, an educator, an innovator, and a catalyst to help accomplish the goals, meet the needs, and achieve the outcomes.

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

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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