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

Lucas and Luna explore the explosive growth of continuous glucose monitors beyond diabetes management. Lucas explains how Abbott's Freestyle Libre and Dexcom's G7 are now being marketed to 'health optimizers' and athletes. He breaks down the key numbers: the total addressable market expanding from 30 million diabetics to 400 million pre-diabetics plus millions of wellness consumers. Luna questions...

Lucas and Luna dig into an escalating regulatory war that most consumers don't even know exists. Fitbit's new sleep apnea detection feature got FDA clearance in March 2026, and Apple's atrial fibrillation algorithm now powers a multi-center clinical trial enrolling 15,000 patients. But behind the headlines, both companies are waging a quiet battle over something much bigger: who gets to own the FD...

Episode 27 of The Digital Health Podcast digs into DarioHealth's playbook: how the company combined FDA-cleared digital therapeutics for diabetes and hypertension with human coaching, and why Wall Street is paying attention. Hosts Lucas and Luna break down Dario's acquisition of Upright, the shift from B2C to B2B2C employer contracts, and the unit economics that make the model work. Plus, a look a...

Episode 26 of The Digital Health Podcast examines DarioHealth's strategy of combining FDA-cleared digital therapeutics with human coaching to boost engagement and outcomes. Lucas and Luna break down the company's pivot from consumer blood pressure and glucose tracking to a B2B chronic condition management platform. They discuss the 2025 acquisition of digital physical therapy platform Vori Health,...

Lucas and Luna break down how digital therapeutics actually get approved. Using Pear Therapeutics' reSET-O as a case study, they walk through the FDA's new Software Precertification Pilot, the difference between a wellness app and a regulated digital therapeutic, and why the failure rate for DTx submissions is still above 60 percent. They also explore how companies like Akili Interactive and Big H...

In this episode, Lucas and Luna explore how the Apple Watch's FDA-cleared ECG feature fundamentally altered the regulatory pathway for consumer health wearables. They trace the 2018 landmark decision that allowed a mass-market device to claim medical-grade heart rhythm monitoring, and examine the ripple effects on startups like AliveCor and Fitbit. The conversation dives into the practical trade-o...

Lucas and Luna explore the emerging field of 'exercise is medicine' — where health apps and wearables are being used to prescribe physical activity as a formal treatment. They dig into the evidence behind the concept, the companies leading the charge, and why this isn't just another wellness trend but a potential shift in how doctors approach chronic disease. Specific focus on the 'Exercise Is Med...

Lucas and Luna unpack the surprisingly complex logistics behind telemedicine prescriptions. They focus on the specific case of Truepill, the digital pharmacy that powered Hims & Hers and Nurx before its collapse in 2025. The hosts walk through how prescriptions flow from an online consultation to a patient's mailbox, the role of pharmacy benefit managers, and why state-by-state licensing still cre...

Lucas and Luna dive into the quiet operational revolution behind hospital-at-home programs, using Mayo Clinic's advanced care at home program as the anchor. They discuss the specific software infrastructure that makes remote monitoring, medication management, and virtual rounding work at scale — including the real numbers on patient outcomes and cost savings. The episode explores why earlier telem...

Episode 20 of The Digital Health Podcast explores a growing legal tightrope: who pays when a wearable or an algorithm misses a diagnosis? Lucas and Luna break down the 2025 case of a consumer-grade ECG patch that failed to flag a cardiac event, and how the FDA, device makers, and doctors are all pointing fingers. They walk through the distinction between software as a medical device and general we...

The Holter monitor has been the gold standard for cardiac arrhythmia detection since the 1950s. But in the past two years, single-use wearable ECG patches have quietly overtaken it in both diagnostic yield and patient compliance. This episode unpacks the numbers: a 2024 JAMA study showing patches detect 23% more arrhythmias than Holters, and how companies like iRhythm (Zio patch) and Mayo Clinic s...

Lucas and Luna examine the battle between Headspace and Calm for corporate wellness contracts, a market worth an estimated $3.4 billion annually. They break down how each company positions its product—Headspace leaning on clinical validation and enterprise features like coaching, Calm betting on brand ubiquity and celebrity content—and why employers are starting to demand proof of ROI measured in...

In this episode of The Digital Health Podcast, Lucas and Luna explore a surprising new frontier in digital health: the hearing aid market. With the FDA's over-the-counter rule change now two years old, a wave of startups and tech giants are reimagining hearing aids as consumer wearables. Lucas breaks down how companies like Sony, Jabra, and startup Whisper are using smartphone-based tuning, AI-dri...

Lucas and Luna explore Pear Therapeutics' reSET-O, the first FDA-authorized prescription digital therapeutic for opioid use disorder. They unpack how the app works as a cognitive behavioral therapy delivery system, the clinical trial data behind its 40% reduction in abstinence failure, and the business challenges Pear faced before bankruptcy. This episode drills into one specific case to understan...

Episode 15 of The Digital Health Podcast digs into a surprising low-tech device that is quietly transforming how pharmaceutical companies and researchers run clinical trials: the connected body weight scale. Lucas and Luna explore how a single company, Withings, transitioned from consumer bathroom scales to FDA-cleared medical devices used in obesity and cardiovascular drug trials. They break down...

Lucas and Luna explore the emerging world of digital therapeutics — software-based treatments that are FDA-cleared to treat medical conditions. They focus on Akili Interactive's EndeavorRx, the first prescription video game for ADHD, and discuss the business challenges facing the digital therapeutic industry: reimbursement, physician adoption, and patient engagement. Lucas explains how Akili pivot...

In this episode of The Digital Health Podcast, Lucas and Luna explore how Tempus AI is creating an operating system for precision medicine. They break down the company's $6 billion data flywheel, how it processes genomic and clinical data from over 7 million patients, and why its partnership with Natera is expanding liquid biopsy access. The hosts discuss Tempus's unique business model, its 2024 I...

Lucas and Luna unpack how Masimo, a B2B medical device company founded in 1989, quietly beat Apple, Fitbit, and Garmin to become the first brand to get a prescription pulse oximeter cleared by the FDA for consumer use — the Masimo W1 watch. They trace the story from Masimo's breakthrough in signal extraction technology during the 1990s pulse oximetry patent wars, through the company's decade-long...

Episode 11 of The Digital Health Podcast with Fexingo dives into the 'Hospital at Home' model — specifically, how the Mayo Clinic and Kaiser Permanente are turning acute care into home-based monitoring. Lucas and Luna unpack the data: a 2025 JAMA study showing 20% lower readmission rates and 30% cost savings for patients enrolled in virtual hospital programs. They explore the tech stack — RPM devi...

Episode 10 of The Digital Health Podcast dives into Zocdoc's quiet transformation from a straightforward appointment-booking portal into a digital front door for the $4.5 trillion U.S. healthcare system. Lucas and Luna explore the company's 2025 data-sharing partnerships with Epic Systems and Cerner, its controversial pivot to charging patients a $10 monthly subscription for same-day access, and t...

Lucas and Luna dive into Tempus AI, the genomic testing and data platform company that has become one of the most ambitious bets in digital health. They explore how Tempus compiles massive clinical and molecular datasets, uses AI to match patients with clinical trials, and generates real-world evidence for drug development. The episode focuses on the company's scale: over 500,000 patients' genomic...

In this episode of The Digital Health Podcast, Lucas and Luna explore how continuous glucose monitors (CGMs) are breaking out of diabetes management and into the wellness market. They focus on the specific case of Abbott's Lingo, an over-the-counter CGM targeting health-conscious consumers, and compare it to Dexcom's Stelo. The hosts discuss the clinical evidence behind glucose tracking for non-di...

In this episode of The Digital Health Podcast, Lucas and Luna dissect how AliveCor — the small cardiac-diagnostics company that took on Apple over the Apple Watch ECG — won a quiet but significant FDA clearance in April 2026 for its Kardia 12L, a personal 12-lead ECG system that fits in a pocket. They walk through the regulatory strategy, the KardiaMobile 6L’s 2019 clearance as the previous milest...

Episode 6 of The Digital Health Podcast zooms in on the Insulet Omnipod 5, the first tubeless automated insulin delivery system. Lucas and Luna break down how this wearable patch pump, paired with a smartphone app and continuous glucose monitor, creates a closed loop that adjusts insulin in real time. They discuss the 2022 FDA approval, the pivotal clinical trial showing a 2.1 percentage point imp...

Lucas and Luna dive into the Oura Ring's surprising rise from a niche sleep-tracking gadget to a legitimate research-grade wearable used by the NIH, Stanford, and major pharmaceutical companies. With over 4 million units sold and more than 1,200 peer-reviewed studies citing Oura data, the ring has become a critical tool for remote clinical trials and early disease detection. Lucas explains how Our...