The Digital Health Podcast with Fexingo: Wearables, Diagnostics, and Health Software

Episode 4 of The Digital Health Podcast with Fexingo dives into the looming Medicare telehealth reimbursement cliff set for December 31, 2026. Lucas and Luna unpack the specific flexibilities—like audio-only visits and originating site waivers—that expire, and what that means for virtual care startups. With $250 billion in telehealth claims since 2020 and 40% of Medicare beneficiaries using virtua...

Lucas and Luna examine the FDA's growing backlog of software-as-medical-device submissions, which hit over 1,200 pending applications in early 2026. They trace how the agency's review capacity hasn't kept pace with the explosion of AI diagnostics, digital therapeutics, and remote monitoring tools. The conversation focuses on the specific bottleneck at the 510(k) clearance pathway for SaMD, using t...

In May 2026, continuous glucose monitors are no longer just for diabetics. Dexcom's over-the-counter CGM, the Stelo, launched last fall and has already enrolled over 400,000 users — a third of whom have no diabetes diagnosis. Lucas and Luna dig into the numbers: how Dexcom priced the device at $89 a month, why the FDA allowed OTC sales for the first time, and what this means for the metabolic heal...

In the premiere episode of The Digital Health Podcast, hosts Lucas and Luna examine the landmark Apple Heart Study — the largest virtual clinical trial ever conducted, with over 400,000 participants. They break down how the study's one specific finding about atrial fibrillation detection paved the way for a new era in remote diagnostics, and what it means for the future of wearable-driven healthca...