FOR IMMEDIATE RELEASE
FDA Clears First All-in-One At-Home Kit for Daily Chronic-Condition Monitoring
Pocket-size platform combines finger-stick blood, saliva and connected-vital sensors to transmit clinician-grade data within minutes
SAN FRANCISCO – November 21, 2025
Chronic-disease patients who currently make monthly trips to labs or clinics can now check key biomarkers from their kitchen tables after the U.S. Food & Drug Administration granted 510(k) clearance Wednesday to VitaLink Inc.’s “ChroniSense” kit, the first over-the-counter system cleared for simultaneous blood, saliva and vital-sign monitoring in diabetes, hypertension and heart-failure populations.
The clearance arrives as one in two U.S. adults—roughly 133 million Americans—manage at least one chronic illness, a cohort that drives 90 percent of the nation’s $4.5 trillion annual health-care spend, according to the National Association of Chronic Disease Directors. Clinical data submitted to FDA showed ChroniSense delivered lab-comparable results for HbA1c, NT-proBNP, LDL cholesterol and systolic blood pressure in a 98.4 percent concordance study involving 1,200 users aged 18-82 across eight states.
“We designed ChroniSense to close the 30-day information gap between office visits, when most cardiac de-compensations or glycemic spikes occur unnoticed,” said Dr. Maya Patel, VitaLink co-founder and chief executive. “Patients receive a push notification if their NT-proBNP rises 20 percent above baseline—giving them a 7- to 10-day runway to titrate medication or seek care before a hospital event.”
Each kit—priced at $149 and reimbursable under CMS Remote Physiologic Monitoring codes—contains a Bluetooth scale, blood-lancette cartridge, saliva funnel and AI-enabled hub that transmits encrypted readings to a HIPAA-compliant cloud reviewed by the patient’s own clinician. A separate NasRED biosensor, highlighted in ACS Nano this year, allows attomolar detection of inflammatory markers at one-millionth the sample volume required by legacy ELISA platforms, slashing per-test cost to roughly $2 while returning results in 90 seconds .
Market uptake is projected to be swift: Parks Associates forecasts the U.S. home-testing segment will grow 18 percent CAGR to $9.6 billion by 2028, accelerated by value-based contracts that penalize hospitals for avoidable admissions. Early adopter CommonSpirit Health will distribute 5,000 ChroniSense kits next quarter to heart-failure patients in rural Nebraska and Nevada, aiming to cut readmissions 15 percent in the first year.
“Anything that moves monitoring out of the ICU and into the living room aligns with our pay-for-performance goals,” said Dr. Luis Ortega, CommonSpirit’s VP of Population Health, in an interview. “We’ve modeled $3,200 savings per patient per year if even one acute admission is avoided.”
The device is available immediately nationwide through Amazon Pharmacy, Walgreens.com and VitaLink’s direct-to-consumer site; companion iOS and Android apps launch December 1 with Apple Health & Epic MyChart integration.
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