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

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 at the regulatory gray zone when software plus a coach replaces a medication. Specific numbers: Dario's $22 million revenue in 2025, 70% gross margin on software alone, and the 40% engagement drop-off after month three.

#DarioHealth #DigitalTherapeutics #DiabetesCoaching #HypertensionManagement #UprightAcquisition #B2B2C #EmployerHealthPlans #FDAWaiver #SoftwareAsMedicalDevice #HealthCoaching #UnitEconomics #PatientEngagement #DigitalHealthPodcast #BusinessAndTechnology #FexingoBusiness #BusinessPodcast #HealthTech #ChronicCareManagement

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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, how Dario's per-member-per-month pricing works for self-insured employers, and why the blended model of software plus live coaching drives higher activation rates than pure apps. The conversation also touches on the broader trend of digital health companies adding clinical services to their tech stacks, and what it means for competitors like Teladoc and Omada.

#DigitalHealth #HealthTech #DarioHealth #DigitalTherapeutics #ChronicCare #Coaching #VoriHealth #B2BHealthcare #EmployerHealth #HealthSoftware #Business #Technology #FexingoBusiness #BusinessPodcast #HealthPodcast #DigitalHealthPodcast #MedTech #ValueBasedCare

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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 Health are navigating the evidence bar. If you're building in health tech, this episode gives you the regulatory roadmap that most founders get wrong.

#DigitalTherapeutics #FDAApproval #PearTherapeutics #reSETO #AkiliInteractive #BigHealth #SoftwarePrecertification #RegulatoryScience #HealthTech #DTx #Business #Technology #HealthcareInnovation #ClinicalTrials #EvidenceBar #FexingoBusiness #BusinessPodcast #TheDigitalHealthPodcast

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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-offs: sensitivity vs. specificity, the burden of false positives, and what the data from over 100 million wearables actually tells cardiologists. Lucas brings the numbers from Apple's own atrial fibrillation study published in the New England Journal of Medicine, while Luna challenges whether FDA clearance is meaningful without peer-reviewed accuracy benchmarks. They also touch on the current regulatory bottleneck at the FDA's Digital Health Center of Excellence, and whether the agency has the bandwidth to vet 200+ new device applications per year. A must-listen for anyone tracking the collision between consumer electronics and regulated medicine.

#AppleWatchECG #FDA #WearableHealth #AtrialFibrillation #AliveCor #Fitbit #DigitalHealth #Regulatory #Cardiology #HealthTech #ClinicalValidation #SensitivityVsSpecificity #ConsumerWearables #NEJM #HealthData #Business #Technology #FexingoBusiness #BusinessPodcast

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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 Medicine' initiative from the American College of Sports Medicine, how Apple Watch and Fitbit are being integrated into clinical workflows, and the startups building prescription-grade movement programs. A look at the data, the regulatory path, and the business model that could make exercise a standard part of your next doctor's visit.

#ExerciseIsMedicine #DigitalHealth #Wearables #HealthTech #PrescriptionExercise #ACSM #AppleWatch #Fitbit #Luna #Lucas #Fexingo #Business #BusinessPodcast #FexingoBusiness #HealthcareInnovation #ChronicDisease #PreventiveMedicine #HealthApps

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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 creates friction. They discuss the current regulatory landscape as of May 2026, including the DEA's latest rules on controlled substance e-prescribing and how startups like Honeybee Health are building direct-to-patient dispensing. Listeners will come away understanding the difference between a prescription written and a prescription fulfilled — and why that gap matters for the future of digital health.

#Telemedicine #Prescriptions #Truepill #DigitalPharmacy #HimsAndHers #Nurx #HoneybeeHealth #DEA #EPrescribing #PharmacyBenefitManagers #StateLicensing #ControlledSubstances #DirectToPatient #BusinessAndTechnology #FexingoBusiness #BusinessPodcast #DigitalHealth #HealthcareLogistics

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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 telemedicine efforts failed, what platforms like Biofourmis and Current Health are doing differently, and why the CMS waiver extension in early 2026 gave hospital-at-home its biggest tailwind yet. A concrete look at how health systems are turning the hospital room into a software-defined space.

#HospitalAtHome #MayoClinic #Biofourmis #CurrentHealth #VirtualCare #RemoteMonitoring #HealthSoftware #Telemedicine #CMS #AdvancedCare #DigitalHealth #Wearables #HealthcareCosts #PatientOutcomes #Business #Technology #FexingoBusiness #BusinessPodcast

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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 wellness products, and why the liability gap is widening as more health data flows through apps, not clinics. Specific focus on a Florida lawsuit where a patient sued a smartwatch maker and a telehealth platform after a missed arrhythmia — and how the court ruled. No hot takes, just the legal architecture that every startup building health software needs to understand.

#DigitalHealth #HealthTech #MedicalLiability #FDA #Wearables #ECG #Telehealth #SoftwareAsMedicalDevice #GeneralWellness #ProductLiability #HealthData #StartupRisk #Business #Technology #FexingoBusiness #BusinessPodcast #HealthSoftware #Regulation

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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 spinout Preventice Solutions drove the shift. Lucas and Luna explore why adhesive patches with 14-day wear time capture events Holters miss, how reimbursement changed after the CMS expanded CPT codes for extended monitoring in 2023, and what this means for the $7 billion ambulatory cardiac monitoring market. Specific, grounded, and forward-looking.

#WearableECG #HolterMonitor #iRhythm #ZioPatch #PreventiceSolutions #CardiacMonitoring #Arrhythmia #DigitalHealth #Diagnostics #JAMA #CMS #Reimbursement #HealthcareInnovation #MedTech #WearableTech #ClinicalValidation #FexingoBusiness #BusinessPodcast

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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 reduced healthcare claims. The episode drills into the key number: a 28 percent reduction in anxiety scores Headspace reported in a 2023 employer study, versus Calm's 19 percent reduction in a workplace stress trial. Lucas explains how the competitive dynamics mirror earlier platform wars in fitness tech, and why the winner may be determined not by user satisfaction but by integration with health insurance billing codes.

#Headspace #Calm #DigitalHealth #MentalHealth #EmployerWellness #CorporateWellness #MeditationApps #HealthcareROI #HealthTech #BehavioralHealth #Benefits #WorkplaceWellness #ROI #ClinicalValidation #Business #Technology #FexingoBusiness #BusinessPodcast

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