RAPID, BCIs & the Future of FDA Review
This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by former FDA division director and current Director of Medical Affairs at Precision Neuroscience, Vivek Pinto, to talk medical device regulation, innovation, and what FDA reviewers are really thinking during submission review.
Vivek shares stories from his 12+ years at FDA, including his time leading teams in physical medicine and neuromodulation, mentoring reviewers, and helping shape decisions around emerging technologies like brain-computer interfaces (BCIs). The group dives into FDA culture, the realities of balancing risk and access, and why understanding the patient journey matters more than ever.
The episode also covers:
FDA’s new RAPID pilot program and the future of CMS/FDA collaboration
Key takeaways from the 2026 REdI Conference
Why sponsors need to “tell the story” in submissions
New PMA approvals, including Signatera™ CDx and Atellica IM free PSA II
FDA’s growing focus on real-world evidence (RWE)
Patient-focused drug/device development and patient-reported outcomes
Challenges with the Office of Combination Products (OCP)
How FDA staff think about benefit-risk and access decisions
The emotional impact of seeing devices change patients’ lives
Plus: new CDRH Learn modules, updated ELP topics, digital health and TEMPO, and the importance of flexibility and creativity inside FDA.
As always, there are terrible medical jokes, regulatory tangents, and strong opinions about healthcare innovation.
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