FDA Breakthrough Device · Acoustic AI for dysphagia

Powering early intervention

A smartphone, a swallow, and an answer. Sipple listens to swallow and breath sounds and returns an objective aspiration-risk assessment in under a minute, without radiation, sedation, or patient transport.

photo slot · NICU bedside

The problem

The magnitude is hard to swallow

In the U.S. alone, hundreds of thousands of infants, more than a million children and over twelve million adults live with dysphagia: difficulty or dysfunction in swallowing. Most are screened by observation, if they are screened at all.

500K
U.S. infants with dysphagia
1.2M
U.S. children with dysphagia
12M+
U.S. adults with dysphagia

The stakes

If undetected, dysphagia can be life-threatening

  • Aspiration pneumonia
  • Lung disease
  • Malnutrition and dehydration
  • Developmental delays in children
  • Hospital readmission
  • Delayed detection of silent aspiration

A smartphone and AI system that transforms the detection and management of dysphagia.

FDA

Breakthrough Device Designation

U.S. Food and Drug Administration · August 2025
NASPGHAN

Pediatric validation presented to the field

NASPGHAN 2025 · PAS 2026 · New York Academy of Sciences
BCH

Validated against VFSS at Boston Children's

Further trials at St. Mary's and the University of Florida
IP

Two non-provisional patents filed

PCT underway · NYU innovation grant recipient

How it works

A smartphone, an AI model and a better answer

Sipple couldn't be simpler. No probe, no contrast, no scope. The phone the clinician already carries is the instrument.

9:41REC 00:42

Swallow assessment

Patient AM-04 · NICU · feed 6

Aspiration riskLow
ConfidenceHigh
Swallows analyzed12
Share with care team
photo slot · bedside recording

The recording

The clinician places the smartphone near the patient and starts the Sipple app. It captures swallowing and the associated breath sounds in real time, during an ordinary feed or meal.

The analysis

Our AI model analyzes the sound waves and detects the subtle patterns that distinguish safe from unsafe swallows: the patterns that separate patients who aspirate from those who do not.

The answer

An aspiration-risk result and a clinician-grade report, in under a minute, shareable with the care team under HIPAA. Repeat it at the next feed and the trend builds itself.

Anyone. Anywhere. Anytime.

Clinical validation

A tried and tested breakthrough

In August 2025 the FDA awarded Sipple Breakthrough Device designation. Ahead of anticipated full FDA authorization for dysphagia detection and monitoring in infants aged 0 to 15 months, we are completing clinical trials at Boston Children's Hospital, St. Mary's Children's Hospital in New York, and the University of Florida.

96%
Sensitivity

Sipple rarely misses a problem.

95%
Negative predictive value

When Sipple says "safe," it is very likely correct.

82%
Positive predictive value

A flagged swallow is worth a closer look.

80%
Specificity

Fewer healthy infants sent for imaging.

Pediatric trial sites · infants 0–15 months

  • Boston Children's HospitalValidation complete
  • St. Mary's Children's Hospital, New YorkIn progress
  • University of Florida, GainesvilleIn progress

Adult & caregiver app

  • Gaylord Specialty Healthcare, ConnecticutCommencing
  • Weill Cornell Medicine, New YorkCommencing

In their words

What clinicians tell us

“Current bedside assessments are subjective and episodic. Sipple gives my team objective, repeatable data, across every care transition.”

Dr. Louisa Ferrara-GonzalezBoard-Certified Swallowing Specialist · NYU Langone

From insight to innovation

It started with the tools we didn't have

Conventional bedside methods, observation and cervical auscultation, suffer from low and highly variable sensitivity. The instrumental gold standards, videofluoroscopy and endoscopy, bring radiation, cost, invasiveness, family stress and limited access. The result is a system that is episodic, referral-dependent and blind to day-to-day change.

Dr. Caroline Martinez, a pediatrician with expertise in biomedical informatics, assembled a multidisciplinary team to build what the bedside was missing: an objective, on-demand aspiration-risk assessment that runs on the phone already in the room.

Dr. Caroline Martinez, MD, FAAP, MSFounder & CEO · Neurodevelopmental Pediatrician, Mount Sinai
photo slot · founder in clinic

Getting started

From a first conversation to a monitored population

01

You inquire

Tell us your setting and your population. We'll have a conversation, or two, about where Sipple fits your workflow.

02

We pilot together

A single unit, a handful of clinicians, the app on their phones. No capital equipment and nothing to install at the bedside.

03

You deploy

Clinician portal, role-based access, EHR and FHIR integration, and a BAA. Reimbursement maps to existing CPT codes.

04

You monitor

Rescreen at every transition. Trends the whole care team can see, from the NICU to the first weeks at home.

Substantial market, small price to pay

Three million pediatric tests a year, and ten times that for adults

Some three million pediatric dysphagia tests are performed annually in the U.S., with roughly ten times that number for adults and seniors. International markets add significant further expansion.

A single gold-standard test commonly costs around $3,000 and a significant amount of staff time. Sipple is purchased by hospitals, NICUs, clinics and home-care organizations as a multi-use subscription tiered by monthly recording volume.

  • CPT 92610Evaluation of swallowing function
  • CPT 92526Treatment of swallowing dysfunction
  • CPT 99453Remote monitoring setup
  • SaMD codesDedicated codes evolving, 2026 onward

Investment opportunities in Sipple

Gold-standard imaging

$3,000
Typical cost of a single VFSS or FEES study, plus radiology or scope time, transport and scheduling.

Sipple assessment

$35
Approximate cost per assessment on a volume-tiered subscription. Aligned with CPT codes reimbursed by Medicare, Medicaid and most commercial insurers.

The team

Built by clinicians, backed by experience

Chief Executive Officer

Caroline Martinez, MD, FAAP, MS

Neurodevelopmental pediatrician and associate professor at Mount Sinai for over 15 years. NYU MS in Biomedical Informatics. Parenting Center co-founder.

Chief Clinical Officer

Louisa Ferrara-Gonzalez, PhD, CCC-SLP, BCS-S

Board-certified swallowing specialist and neonatal speech-language pathologist. Clinical researcher, NYU Langone.

Chief Technical Officer

Simon Johnson

HL7 FHIR-certified software engineer. Technical lead for Jupyter Health. Solution architecture at Weill Cornell Medicine and NewYork-Presbyterian.

Chief Marketing Officer

David Pring

Adjunct faculty, NYU Stern School of Business. Managing partner, BlindSpot Partners. Berkley Center for Entrepreneurship.

Executive Chair

Magdalene Cook, MD

Over 20 years as an executive, investor and advisor in the life sciences industry. MD, Columbia University College of Physicians and Surgeons.

Clinical advisory board

  • Jen Bragg, MD · Neonatologist and Medical Director, Mount Sinai Hospital
  • Mandi Pek, MS, RD, CSP, RDN · Director of Clinical Nutrition, Mount Sinai Hospital
  • Neina Ferguson, PhD, CCC-SLP · Pediatric feeding and swallowing specialist
  • Emily Jaffe, MD · Executive Medical Director, Highmark Health

Ready to start?

Every deployment began with a single recording

Hospitals, NICUs, clinics, home care, research sites and platform partners: tell us where you are and we'll show you Sipple in your setting.

Follow the path to clearance

Trial results, conference presentations and the FDA milestones, a few times a year. No noise.