← Product Code [PHZ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ) · K221614 # TytoCare Lung Sounds Analyzer (K221614) _Tyto Care , Ltd. · PHZ · Feb 24, 2023 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K221614 ## Device Facts - **Applicant:** Tyto Care , Ltd. - **Product Code:** [PHZ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ.md) - **Decision Date:** Feb 24, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1900 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** AI/ML, Software as a Medical Device, Pediatric ## Intended Use The TytoCare Lung Sounds Analyzer is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the TytoCare Lung Sounds Analyzer result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data. ## Device Story Web-based software system for clinical assessment of lung auscultation data. Inputs: audio files of lung sounds recorded by FDA-cleared Tyto Stethoscope. Processing: cloud-hosted algorithm analyzes recordings to detect presence of wheeze. Outputs: positive/negative wheeze detection result displayed via web interface. Used in clinical or home environments by clinicians or lay users. Output assists healthcare providers in clinical decision-making; requires professional interpretation. Benefits: provides automated decision support for identifying potential wheezing in patients. ## Clinical Evidence Retrospective validation study using 371 recordings from 359 patients (age >2 years). Ground truth established by majority vote of three blinded pulmonologists. Sensitivity: 0.69 (95% CI: 0.57–0.78); Specificity: 0.92 (95% CI: 0.88–0.95). Clinical performance (AUC) compared to non-pulmonologist physicians: Device AUC 0.91 (0.86-0.94) vs. Reader AUC 0.83 (0.78-0.86), supporting non-inferiority (difference 0.09, 95% CI 0.04-0.13). ## Technological Characteristics Cloud-hosted software system; processes audio input from Tyto Stethoscope. No physical sensors; relies on external hardware for data acquisition. Connectivity via IP network. Software lifecycle follows IEC 62304. Risk management per ISO 14971. Usability engineering per IEC 62366-1. ## Regulatory Identification A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values. ## Predicate Devices - wheezo WheezeRate Detector ([K202062](/device/K202062.md)) ## Reference Devices - Tyto Stethoscope ([K181612](/device/K181612.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 24, 2023 Tyto Care Ltd. Stella Perry RA&QA Director 14 Beni Gaon Street Netanya, 4250803 Israel Re: K221614 Trade/Device Name: TytoCare Lung Sounds Analyzer Regulation Number: 21 CFR 868.1900 Regulation Name: Diagnostic Pulmonary-Function Interpretation Calculator Regulatory Class: Class II Product Code: PHZ Dated: January 26, 2023 Received: January 26, 2023 Dear Stella Perry: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ### Rachana Visaria -S Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K221614 #### Device Name TytoCare Lung Sounds Analyzer #### Indications for Use (Describe) The TytoCare Lung Sounds Analyzer is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the TytoCare Lung Sounds Analyzer result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Prescription Use (Part 21 CFR 801 Subpart D) > Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary | Submitter Name
and Address: | Tyto Care Ltd.
14 Beni Gaon Street
Netanya, Israel, 4250803 | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Stella Raizelman Perry
RA & QA Director
Email: stellar@tytocare.com
Phone Number: +972 72-2210750
Fax Number: +972 72-2210752 | | Establishment
Registration
Number: | 3012678246 | | Date Prepared: | February 24, 2023 | | Device Trade
Name(s): | TytoCare Lung Sounds Analyzer | | Device Common
Name: | TytoCare Lung Sounds Analyzer | | Classification: | Name: Diagnostic pulmonary-function interpretation
calculator
Product code: PHZ
Secondary product code: DQD
Regulation No: 21 CFR 868.1900
Class: II
Panel: Anesthesiology | ### Predicate Device(s): Device name wheezo WheezeRate Detector (by Respiri Limited) 510(k) No. K202062 Date of Clearance March 11, 2021 #### Reference Device(s): | Device name | 510(k) No. | Date of Clearance | |------------------|------------|-------------------| | Tyto Stethoscope | K181612 | December 17, 2018 | {4}------------------------------------------------ #### Intended use / indication for use statement The TytoCare Lung Sounds Analyzer is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the TytoCare Lung Sounds Analyzer result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data. #### Device description The TytoCare Lung Sounds Analyzer is a web-based software system designed to aid in the clinical assessment of lungs auscultation sound data by analyzing recorded lung sounds to determine whether a Wheeze is detected within the recorded sound data. The TytoCare Lung Sounds Analyzer Software is intended to process recordings from the FDA-cleared compatible Tyto Stethoscope (Tyto Stethoscope, K181612). The acquisition of the acoustic data (recordings) is carried out by a professional user in a clinical environment or by a lay- user in a non-medical environment, in compliance with the labeling of the Tyto Stethoscope. The system is composed of the following sub-systems: - 1. The TytoCare Lung Sounds Analyzer Application Server (APS) communicates with the TytoCare Lung Sounds Analyzer Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server. - 2. The TytoCare Lung Sounds Analyzer Algorithm Server (ALS) receives an audio file as input and returns an analysis result of positive or negative regarding whether a wheeze was detected as output. - 3. The TytoCare Lung Sounds Analyzer Web Server (WBS) provides a graphic indication whether a wheeze is detected in the recording. It can be utilized both in patient and clinician side. All the software subsystems (servers and storage) are hosted in the cloud and communicate through IP network. #### Substantial Equivalence to Predicate Devices The following table compares the TytoCare Lung Sounds Analyzer to the predicate and reference device devices: {5}------------------------------------------------ | | Device | Predicate | Reference device | Summary | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | TytoCare Lungs Sounds
Analyzer | wheezo WheezeRate
Detector | Tyto Stethoscope (OTC) | NA | | Device
Manufacturer | Tyto Care Ltd. | Respiri Limited | Tyto Care Ltd. | NA | | 510(k) Number | K221614 | K202062 | K181612 | NA | | Device Class | Class II | Class II | Class II | Same | | Review Panel | Anesthesiology | Anesthesiology | Cardiovascular | Same | | Product code | PHZ
DQD | PHZ | DQD | Same | | Regulation number | 21 CFR 868.1900 | 21 CFR 868.1900 | 21 CFR 870.1875 | Same | | Classification Name | Diagnostic pulmonary-
function interpretation
calculator | Diagnostic pulmonary-
function interpretation
calculator | Stethoscope | Same | | Intended use and
indication for use | The TytoCare Lung Sounds
Analyzer is an over-the-
counter decision support
software system used in the
evaluation of lung sounds in
adults and children (2 years
and older). It automatically
analyzes the acoustic signal | Wheezo is intended to
detect and record
abnormal breath sounds
(continuous adventitious
breath sounds/CABS) at
the windpipe (trachea),
reported as WheezeRate
in adults and children (2 | The Tyto Stethoscope is an
electronic stethoscope that
enables transmission of
auscultation sound data,
whereby a clinician at one
location on an IP network
can listen to the auscultation
sounds of a patient on site or | Same
Both the predicate device and the
subject device have the same
intended use and indication for
use in that both are intended to
detect specific and abnormal
breath sounds in the same | | | Device | Predicate | Reference device | Summary | | | of the lung as recorded by
the FDA cleared compatible
Tyto Stethoscope and
identifies recordings where
a specific abnormal lung
sound suggestive of
"Wheeze", is suspected. It
is not intended to detect
other abnormal or normal
lung sounds. A licensed
health care professional's
advice is required to
understand the meaning of
the TytoCare Lung Sounds
Analyzer result. Healthcare
provider should consider
the device result in
conjunction with recording
and other relevant patient
data. | years and older). A
licensed health care
professional's advice is
required to understand the
meaning and importance
of the wheezo readings. | at a different location on the
IP network with the signal
carried on an IP connection
between the two locations.
The Tyto Stethoscope is
intended to be used by
professional users in a
clinical environment or by
lay users in a nonclinical
environment. The device is
for medical diagnostics
purposes only. The device is
not intended for self-
diagnosis. | intended patient population (adult
and pediatric) by the same user
[Health Care Professional (HCP)]
when self-administered by patient
and/or the HCPs.
Both devices are only intended to
be interpreted by HCP and HCP
advice is required for the patient
to understand their result. Both
are labeled OTC. | | Type of use | Over-The-Counter Use | Over-The-Counter Use | Over-The-Counter Use | Same | | Intended users | Intended to be used by
professional users and lay
users. | Intended to be used by lay
users | Intended to be used by
professional users and lay
users | Similar, the TytoCare Lung
Sounds Analyzer is intended for
clinicians and lay users. | {6}------------------------------------------------ {7}------------------------------------------------ | | Device | Predicate | Reference device | Summary | |-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended patient population | Intended for patients of 2 years and older | Intended for patients of 2 years and older | Intended for patients of all ages | Same | | Intended environment | Non-clinical (home) and clinical | Non-clinical (home) | Non-clinical (home) and clinical | Similar.
the TytoCare Lung Sounds Analyzer is intended for both home and clinical environment | | Form | Stand-alone software system | Hardware and Software, hand-held stand-alone device used with smartphone | Hardware and Software, hand-held stand-alone device used with smartphone | Different.
The acquisition of lung sounds of both devices is conducted by FDA cleared device, therefore there is no new question of effectiveness. | | | Device | Predicate | Reference device | Summary | | Device composition | The following modules
compose the TytoCare
Lung Sounds Analyzer:
• The TytoCare Lung
Sounds Analyzer
Application Server (APS)
• The TytoCare Lung
Sounds Analyzer
Algorithm Server (ALS)
• The TytoCare Lung
Sounds Analyzer Web
Server (WBS) provides a
graphic indication
whether a wheeze is
detected in the recording
It can be utilized both in
patient and clinician side. | The wheezo WheezeRate
Detector consists of:
• Wheezo Sensing
Device
• Wheezo App
• Cloud server | Hardware:
• A stethoscope Chest
Piece:
o Stethoscope Adaptor
o TytoCare Device
Software:
• TytoCare Device
Application
[runs on TytoCare Device]
• TytoCare
Application
[runs on the mobile
device]
• Clinician
Application
[runs on the clinician
platform]
• Server software
[runs on the Tyto Server] | Different
The TytoCare Lung Sounds
Analyzer is a Stand-alone
software system used with
compatible Tyto Stethoscope to
record lung sounds. The Wheezo
is Hardware and Software, hand-
held device used with smartphone.
Both devices acquire lung sounds
and provide indication on the
presence of wheeze to the user.
The difference doesn't raise new
questions of safety or
effectiveness. | | Input | Lung sounds recorded by
compatible Tyto
Stethoscope | Lung sounds recorded by
the wheezo device | Lung sounds recorded by
the Tyto Stethoscope | Different
Both devices acquire lung sounds
with device cleared by the FDA
for that purpose | | | Device | Predicate | Reference device | Summary | | | | | | The difference doesn't raise new
questions of safety or
effectiveness | | Device technology
and operating
principle | The recordings are created
by the compatible Tyto
Stethoscope (K181612) and
are sent by the third-party
point of care app to the
clinician app through the
telehealth server.
The telehealth server sends
the set of the lung sound
recordings to the TytoCare
Lung Sounds Analyzer web
server using its dedicated
API.
The telehealth server
subsequently sends the link
to results and the relevant
UI web view to the point of
care app and clinician app.
The algorithm runs
automatically and returns a
response for each audio file
with the indication of
wheezes to the telehealth
server, which sends a
response to both the | User places sensor on
their neck for 30 seconds
to perform a passive
manoeuvre. The device
records, analyses the lung
sounds and quantifies the
presence of wheezing.
The wheezo transfers a
user's breath sound data to
the App using a Smart
Device. The sound data is
analyzed in the algorithm,
which is integrated inside
the App and runs on the
Smart Device. | User place the Tyto
Stethoscope's adaptor in full
contact with the patient's
body, data is recorded and
transmitted from the chest
piece (i.e., the The TytoCare
device mounted with
adaptor) to the user end unit
(i.e., a mobile device such
as smartphone), via Wi-Fi,
and then over the internet to
the clinician end unit (i.e., a
clinician platform such as
PC or laptop. | Same.
Both devices acquire lung
sounds with device cleared by the
FDA for that purpose, analyze the
lung sounds and provide
indication on the presence of
wheeze. | | | Device | Predicate | Reference device | Summary | | | clinician side and the
patient side. | | | | | Sensor type and
technology | NA, software only | Microphone sensor (made
of silicon) acquires, filters
and digitizes the breath
sounds. | Embedded acoustic
piezoelectric contact sensor
captures analog auscultation
sound data, amplifies it,
filters, digitizes and store it. | Different but the difference
doesn't raise new questions of
safety or effectiveness. The
subject device is intended to be
used with compatible Tyto
Stethoscope (reference device) to
record lung sounds.
The predicate and the reference
devices both use a handheld piece
with embedded sensor in the chest
piece to acquire lung sounds. The
safety and performance of the
reference device sensor's type and
technology has been established
previously for acquiring lung
sounds by means of FDA
clearance. | | Sensor location | NA, software only | Trachea | Top part of the chest and the
top part of patient's back
(Left Upper Lobe, Left
Lower Lobe, Right Upper
Lobe, Right Lower Lobe). | Different but the difference
doesn't raise new questions of
safety or effectiveness. The
subject device is intended to be
used with compatible Tyto
Stethoscope (reference device) to
record lung sounds.
The safety and performance of the
reference device sensor's location
for acquiring lung sounds has
been established before by means
of FDA clearance. | | | | | | | | Signal length | The length of the signal is dictated by the recording process of the compatible Stethoscope. The subject device processes the recordings in segments of up to 12 seconds while signals shorter than 6 seconds will not be processed. | 30 seconds | Variable | Different but the difference doesn't raise new questions of safety or effectiveness. The safety and performance of the different signal length that is used in the process of lung sound acquisition by numerous FDA cleared electronic stethoscopes including the reference device as well as Diagnostic Pulmonary-Function Interpretation Calculators including the predicate device was established. Thus, the impact of different signal length on performance does not raise a new question of safety or performance. | | Data transfer and storage | The telehealth server sends the list of the recordings (identified by a unique identifier and time stamp) to the TytoCare Lung Sound Analyzer web server using its dedicated API. The server executes the TytoCare Lung Sounds Analyzer which runs the algorithm and provides the results. Then the TytoCare Lung Sound Analyzer web | Every recording is automatically uploaded to the cloud. However, if an Internet connection is not available, up to 20 most recent recordings will be stored locally on the smartphone. | The stethoscope recordings are transferred to the server using the software of the Tyto Stethoscope. However, if an Internet connection is not available, most recent recordings will be stored locally on the Tyto Stethoscope. | Different medical device data system but the difference doesn't raise new questions of safety or effectiveness. | | | Device | Predicate | Reference device | Summary | | | server initiates the web user
interface.
All the software subsystems
(server and storage) are
hosted in the cloud and
communicate through IP
network. | | | | | Output | • Positive (wheeze
suspected),
• Negative (Wheeze not
suspected),
• The TytoCare lungs
sounds analyzer was not
able to analyze the
recording | Detection and
quantification of wheeze
presence, expressed as
"wheeze rate". | NA | Different but no new questions of
safety and effectiveness as both
the device and the predicate use
software algorithm to detect
abnormal breath sound (wheeze)
in lung recordings. | | Accuracy | Non-inferior to clinical
readers | Non-inferior to clinical
readers… --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K221614](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K221614) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com