Home / Clinical Decision Support & Reference / Personalized Therapy Comfort Settings (PTCS)

Personalized Therapy Comfort Settings (PTCS)

by ResMed · Based in United States → — Creating life-changing health technologies that people love.

Pulmonology Sleep Medicine

Website

Claim this tool

Is this the maker? Claim the company →

Leave this field empty

Correct company / maker

Company website (optional)

Anything else? (optional)

Contact for pricing

Regulatory Status Disclosed

Overview

Personalized Therapy Comfort Settings (PTCS), marketed as Smart Comfort, is an AI-enabled digital medical device developed by ResMed. It is designed to recommend individualized comfort settings for Continuous Positive Airway Pressure (CPAP) therapy, primarily for individuals with obstructive sleep apnea (OSA). This innovative tool leverages proprietary machine learning algorithms, trained on over 100 million nights of de-identified, real-world sleep data, to provide personalized recommendations.

Smart Comfort aims to help new CPAP users adjust to therapy faster and more comfortably, thereby improving confidence and long-term adherence. It considers factors such as age, gender, and Apnea-Hypopnea Index (AHI) to suggest non-prescription comfort settings like ramp speed/start pressure and expiratory pressure relief.

The system is integrated with ResMed’s myAir™ consumer sleep companion app and AirSense™ 11 devices, streamlining user setup and follow-up for clinicians by reducing the need for manual adjustments. It is important to note that these comfort settings support CPAP therapy device usage and do not alter prescribed therapy settings or efficacy.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

AI-enabled personalized comfort settings for CPAP therapy
Leverages machine learning algorithms
Uses de-identified real-world sleep data (over 100 million nights)
Considers user data such as age, gender, and Apnea-Hypopnea Index (AHI)
Recommends settings like ramp speed/start pressure and exhalation relief
Aims to improve CPAP therapy adherence
Provides non-prescription comfort settings (does not alter prescribed therapy)
Integrates with ResMed myAiru2122 app and AirSenseu2122 11 devices
Streamlines user setup and follow-up for clinicians

Use Cases

Helping new CPAP users adjust to therapy faster and more comfortably
Improving long-term adherence to CPAP therapy
Reducing manual adjustments for clinicians in CPAP setup and follow-up
Personalizing CPAP comfort settings based on individual patient data
Supporting CPAP therapy device usage without altering prescribed therapeutic pressure

What Physicians Need to Know

Evidence Base

Personalized Therapy Comfort Settings (PTCS) leverages proprietary machine learning algorithms trained on over 100 million nights of de-identified, real-world sleep data. The algorithms analyze patterns across user data, considering factors such as age, gender, and Apnea-Hypopnea Index (AHI), to recommend optimal non-prescription comfort settings. The FDA submission for PTCS was supported by retrospective real-world evidence.

Clinical Validation Studies

Retrospective real-world evidence from ResMed AirSense 10 and 11 users demonstrated that individuals whose comfort settings aligned with Smart Comfort (PTCS) recommendations showed higher engagement and sustained therapy adherence compared to those using default settings. Analytical validation confirmed consistent and reliable model performance, with no identified safety concerns, and indicated that selecting PTCS-recommended settings is safe, effective, and consistent with real-world clinical practice.

Alert Fatigue Management

PTCS is designed to provide optional recommendations for non-prescription comfort settings (e.g., ramp timing, exhalation relief) rather than generating mandatory alerts. The software does not automatically adjust device settings or modify prescribed therapy parameters. Recommendations are optional and can be accepted, disregarded, or further adjusted by the patient or healthcare provider, thereby inherently minimizing alert fatigue.

Guideline Update Frequency

While there is no explicit mention of 'guideline update frequency' in the traditional sense for clinical guidelines, PTCS utilizes machine learning algorithms trained on extensive datasets. These models would likely undergo periodic updates and refinements as more data becomes available or as algorithms are enhanced, ensuring ongoing relevance and performance. PTCS received FDA clearance in December 2025 and is rolling out in 2026.

Clinical Workflow Integration

PTCS, marketed as Smart Comfort, is designed for seamless integration within ResMed's connected ecosystem, including the myAir app and compatible devices like the AirSense 11. It aims to streamline user setup and follow-up, reducing the need for manual comfort adjustments by clinicians. This allows healthcare providers to dedicate more attention to clinical decision-making and patient support. The core PTCS algorithm integrates via an API and does not have a direct end-user interface.

Physician Tip

PTCS (Smart Comfort) is an AI-enabled tool designed to optimize patient comfort and improve adherence to CPAP therapy by recommending personalized, non-prescription comfort settings. It is crucial to remember that PTCS does not alter prescribed therapeutic pressure or serve as a diagnostic tool. Clinicians can leverage this tool to streamline the initial setup process for new patients and potentially reduce the volume of manual comfort adjustments, thereby allowing more time for addressing complex clinical needs and providing comprehensive patient support. The recommendations provided by PTCS are optional and should be reviewed and adjusted based on individual patient needs and the clinician's professional judgment.

PTCS is integrated into ResMed's existing connected health ecosystem, specifically with the myAir consumer sleep companion app and compatible ResMed AirSense 11 devices. This integration aims to provide a streamlined experience for users and clinicians within the ResMed platform. ResMed also offers broader AirView Integration solutions, which enable the exchange of therapy device data with various third-party patient management systems, potentially facilitating a more consolidated view of patient information within diverse clinical workflows.

At a glance

Pricing Contact for pricing

Deployment Cloud Connected

Visit site

Details

Category	Clinical Decision Support & Reference, Patient Engagement & Education
Pricing	Contact for pricing
Deployment	Cloud-connected
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	1 AI-estimated FDA clearance was received for Personalized Therapy Comfort Settings (PTCS), marketed as Smart Comfort, as the first FDA-cleared AI-enabled medical device to recommend individualized comfort settings for CPAP therapy.
Integrations
EHR	Not specified
Specialties	Pulmonology, Sleep Medicine

What the Web Says

ResMed's Personalized Therapy Comfort Settings (PTCS), marketed as Smart Comfort, is an AI-driven feature designed to recommend personalized comfort settings for CPAP therapy. It aims to help new users adjust to therapy faster and improve long-term adherence by optimizing non-prescription settings like ramp timing and exhalation relief. The system leverages machine learning algorithms trained on millions of nights of real sleep data to provide individualized recommendations.

Overall: Positive

Strengths

Enhances user comfort during CPAP therapy.
Aids new users in adjusting to CPAP therapy more quickly and comfortably.
Potentially improves long-term therapy adherence and sleep outcomes.
Provides personalized comfort suggestions based on individual sleep data and characteristics.
Does not alter prescribed therapeutic pressure or compromise treatment effectiveness.
Streamlines setup and follow-up for clinicians, reducing the need for manual adjustments.

Limitations

Limited U.S. beta launch in early 2026 for new myAir users with AirSense 11 devices, with a broader rollout later in 2026.
The feature is primarily user-facing, though it can also be useful for clinicians.
Relies on the ResMed connected ecosystem, specifically the myAir app and compatible devices like the AirSense 11.
No specific negative reviews or opinions from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra were found in the provided search results.

Based on reviews from: ResMed - Physician Ai Tools, The CPAP Shop, Simply Wall St, HME News, accessdata.fda.gov, Respiratory Therapy, SLEEP | Oxford Academic

Last updated: 2026-07-19

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate Personalized Therapy Comfort Settings (PTCS)

Clinical Value

Ease of Use

Integration

Support & Docs

Value for Money

Your Name *

Email *

Your Role

Specialty

Your Review * (min 50 characters)

Press & Coverage

OEM News

Resmed Wins FDA Nod for AI-Powered Personalized CPAP Therapy

ResMed received FDA clearance for Personalized Therapy Comfort Settings (PTCS), to be marketed as Smart Comfort, an AI-enabled medical device that recommends personalized comfort settings for CPAP therapy. It is the first FDA-cleared AI-enabled medical device of its kind and will launch in early 2026 in a limited U.S. beta version.

2025-12

unknown

ResMed Secures FDA Clearance for AI-Powered Personalized CPAP Device

ResMed announced FDA clearance for Smart Comfort, previously submitted as Personalized Therapy Comfort Settings (PTCS), an AI-enabled medical device to help individuals with obstructive sleep apnea (OSA) start and continue CPAP therapy. The device uses machine learning models trained on over 100 million nights of sleep data to provide tailored comfort recommendations.

2025-12

FirstWord HealthTech

FDA clears Resmed AI for personalised CPAP therapy - FirstWord HealthTech

ResMed's Smart Comfort, an AI-enabled device for personalized CPAP therapy, has received FDA clearance. The technology uses machine learning models and real-world data to generate individualized comfort settings for the AirSense 11 CPAP device.

2025-12

HME News

Resmed receives FDA clearance for AI-enabled CPAP settings | HME News

ResMed has secured FDA clearance for its AI-enabled Personalized Therapy Comfort Settings (PTCS), to be marketed as Smart Comfort, designed to improve CPAP therapy adherence for obstructive sleep apnea patients. The system will be introduced in a limited U.S. beta in early 2026.

2025-12

RMD Stock News

Resmed gets FDA clearance for AI Smart Comfort CPAP tool | RMD Stock News

ResMed received FDA clearance for its Personalized Therapy Comfort Settings, branded as Smart Comfort, an AI-enabled digital medical device for individualized CPAP comfort settings. This tool utilizes machine learning from over 100 million nights of sleep data to optimize therapy.

2025-12

unknown

FDA Clears AI-powered Smart Comfort to Personalize CPAP Comfort Settings

The FDA has granted 510(k) clearance for ResMed's Personalized Therapy Comfort Settings, to be marketed as Smart Comfort, an AI-enabled medical device for personalized CPAP comfort settings. The system aims to boost engagement and adherence for new users of the myAir app paired with an AirSense 11 device.

2025-12

ResMed Investor Relations

Resmed Receives FDA Clearance for Personalized Therapy Comfort Settings, to be Marketed as Smart Comfort, an AI-Enabled, Digital Medical Device That Helps Personalize CPAP Therapy - ResMed Investor Relations

ResMed announced FDA clearance for Personalized Therapy Comfort Settings (PTCS), to be marketed as Smart Comfort, an AI-enabled digital medical device. This innovation aims to personalize CPAP therapy for obstructive sleep apnea patients, with a limited U.S. beta launch planned for early 2026.

2025-12

SLEEP | Oxford Academic

1262 Personalizing PAP Comfort Through AI-enabled Modeling: Retrospective Insights and Future Directions | SLEEP | Oxford Academic

This article discusses retrospective analyses of Personalized Therapy Comfort Settings (PTCS), marketed as Smart Comfort, an FDA-cleared AI-enabled medical device. The study evaluated whether model-guided comfort setting recommendations improved PAP device usage and patient-reported early therapy experience.

2026-05

Videos

Product demos, reviews, and walkthroughs for Personalized Therapy Comfort Settings (PTCS).

Sleep Apneas vs Hypopneas vs RERAs - What's the Difference!?

View all on YouTube

Frequently Asked Questions

How does PTCS leverage AI to personalize therapy comfort settings, and what data inputs are required for its operation?

PTCS, such as ResMed's Smart Comfort, utilizes machine learning algorithms trained on extensive de-identified real-world sleep data, often exceeding 100 million nights, along with user information like age, gender, and Apnea-Hypopnea Index (AHI). This AI analyzes patterns to recommend individualized non-prescription comfort settings, including ramp speed and exhalation relief, without altering prescribed therapeutic pressure.

What regulatory and data privacy compliance measures are in place for PTCS, particularly concerning patient health information (PHI) and AI algorithm transparency?

PTCS solutions like Smart Comfort have received FDA 510(k) clearance as AI-enabled medical devices, indicating a level of regulatory approval. They are developed with clinical oversight and ethical data use, aiming for compliance with privacy laws like HIPAA through robust encryption and access controls. Ensuring transparency in AI algorithms and accountability for AI-driven decisions are ongoing ethical considerations in healthcare AI.

What are the primary alternatives to PTCS for managing patient comfort during therapy, and how does its AI-driven approach offer a distinct advantage?

Traditional alternatives involve manual adjustments based on subjective patient feedback or standardized, pre-set protocols, which can be inconsistent and time-consuming for clinicians. PTCS offers a continuous, adaptive, and data-driven approach by proactively suggesting personalized comfort settings. This can lead to improved patient engagement and sustained therapy adherence by addressing comfort issues more effectively from the outset.

What is the typical cost model for implementing PTCS, and are there considerations for reimbursement or integration into existing healthcare budgets?

Pricing models for AI therapy solutions often include subscription fees per device or patient, or one-time licensing fees with ongoing maintenance. While specific reimbursement pathways for PTCS are evolving, the technology aims to offer cost savings through improved patient outcomes, reduced manual adjustments by staff, and enhanced therapy adherence. Healthcare providers should explore enterprise agreements for integration into existing budgets.

What are the known limitations of PTCS's AI, such as potential biases, accuracy in diverse patient populations, or scenarios where manual override remains critical?

Limitations include the potential for biases if the AI's training data is not representative of diverse patient populations, which could affect accuracy in nuanced discomfort interpretation. AI systems may also lack the human empathy and contextual understanding crucial for comprehensive patient care. Therefore, manual clinician oversight and the ability to override AI recommendations remain critical, as AI is intended to augment, not replace, clinical judgment.

What ethical considerations should physicians be aware of when deploying an AI-driven system like PTCS, particularly regarding patient autonomy and the 'black box' nature of some AI?

Physicians must ensure informed patient consent for data usage and the involvement of AI in their care, maintaining patient autonomy. Addressing the 'black box' nature of some AI, where the reasoning behind recommendations is opaque, is crucial for clinician trust and accountability. Continuous monitoring, bias audits, and clear frameworks for responsibility are essential to ensure equitable and safe AI deployment.