← Product Code [QGM](/submissions/SU/subpart-e%E2%80%94surgical-devices/QGM) · K241902
# Edison System (K241902)
_HistoSonics, Inc. · QGM · Oct 30, 2024 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QGM/K241902
## Device Facts
- **Applicant:** HistoSonics, Inc.
- **Product Code:** [QGM](/submissions/SU/subpart-e%E2%80%94surgical-devices/QGM.md)
- **Decision Date:** Oct 30, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4405
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic
## Indications for Use
The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
## Device Story
Edison System uses histotripsy—non-thermal, mechanical focused ultrasound—to destroy liver tumors. System inputs include diagnostic ultrasound imaging (via integrated GE LOGIQ E10s) to identify and target tumors. Device delivers high-amplitude, microsecond-duration ultrasound pulses to induce controlled acoustic cavitation (bubble cloud) at focal points. Bubble cloud expansion/collapse mechanically destroys tissue into acellular lysate. Operated in professional healthcare environments by clinicians. System includes robotic 6-DOF arm, treatment head with therapy transducer, and diagnostic probe. Software controls robotic arm to scan bubble cloud through planned treatment volume. Output is visual guidance for targeting and mechanical ablation of tumor tissue. Benefits include non-invasive tumor destruction without thermal damage. Enhancements in subject device include 128-channel transducer/generator for larger bubble cloud and faster treatment times compared to predicate.
## Clinical Evidence
No human clinical data provided. Evidence consists of bench testing (electrical safety IEC 60601-1, EMC IEC 60601-1-2, acoustic characterization IEC 60601-2-62, software ISO 62304) and a GLP-compliant preclinical porcine study comparing the subject device to the reference device. All acceptance criteria met.
## Technological Characteristics
Focused ultrasound system (QGM). Components: 128-channel therapy transducer, 6-DOF robotic arm, GE LOGIQ E10s diagnostic probe. Materials: SEBS membrane, polypropylene frame, silicone web, degassed water coupling. Connectivity: Integrated diagnostic ultrasound. Software: Version 3.0.1. Sterilization: Single-patient use disposable components. Energy: High-intensity therapeutic ultrasound (HITU).
## Regulatory Identification
The Edison System is a focused ultrasound system for non-thermal, mechanical tissue ablation. It uses high amplitude, short-duration focused ultrasound pulses to induce acoustic cavitation (a 'bubble cloud') at a focal location to mechanically destroy soft tissue, resulting in a homogenous acellular lysate. It is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors.
## Special Controls
In combination with the general controls of the FD&C Act, the focused ultrasound system for non-thermal, mechanical tissue ablation is subject to the following special controls:
## Predicate Devices
- Edison System ([K233466](/device/K233466.md))
## Reference Devices
- Edison System ([DEN220087](/device/DEN220087.md))
- GE LOGIQ E10s ([K231989](/device/K231989.md))
- GE LOGIQ E10s ([K211524](/device/K211524.md))
## Submission Summary (Full Text)
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October 30, 2024
HistoSonics, Inc. Leeanne Swiridow Sr. Manager. Regulatory Affairs 16305 36th Avenue N Suite 300 Plymouth, Minnesota 55446
Re: K241902
Trade/Device Name: Edison System Regulation Number: 21 CFR 878.4405 Regulation Name: Focused Ultrasound System For Non0thermal, Mechanical Tissue Ablation Regulatory Class: Class II Product Code: QGM Dated: October 1, 2024 Received: October 1, 2024
Dear Leeanne Swiridow:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Digitally signed by Long H. Chen
Long H. Chen -S -s
Date: 2024.10.30 09:27:31 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
Submission Number (if known)
K241902
Device Name
Edison System
Indications for Use (Describe)
The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
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)
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Image /page/4/Picture/2 description: The image shows the logo for Histosonics. The logo features a stylized "H" symbol to the left of the word "HISTOSONICS" in a sans-serif font. A registered trademark symbol is located to the upper right of the word "HISTOSONICS".
## 510(k) Summary
HistoSonics, Inc. Traditional 510(k) Edison® System
## 1. Submitter
## 510(k) Submitter:
HistoSonics, Inc. 16305 36th Avenue N, Suite 300 Plymouth, MN 55446 U.S.A.
## Contact Person:
LeeAnne Swiridow Sr. Manager, Regulatory Affairs Phone: 612-803-8508 Fax: 734-929-9020 Email: leeanne.swiridow@histosonics.com
## Date Prepared: June 28, 2024
#### 2. Subject Device
| Trade Name: | Edison® System |
|----------------------|-----------------------------------------------------------------------|
| Classification Name: | Focused ultrasound system for non-thermal, mechanical tissue ablation |
| Regulation Number: | 21 CFR Part 878.4405 |
| Product code: | QGM |
#### 3. Predicate Device
| Device Name: | Edison System |
|----------------------|-------------------------------------------------|
| 510(k) Number: | K233466 |
| Reference Device: | Edison System |
| De Novo: | DEN220087 |
| Classification Name: | Focused ultrasound system for non-thermal, mech |
| Regulation Number: | 21 CFR Part 878.4405 |
nanical tissue ablation 21 CFR Part 878.4405 QGM
#### 4. Indications for Use
Product code:
The Edison® System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
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## 5. Device Description
The HistoSonics Edison System (the "System") provides users with a means to identify, target and destroy liver tumors entirely non-invasively using histotripsy, a non-ionizing, nonthermal, mechanical process of focused ultrasound. Histotripsy is created by delivering high amplitude, very short (microsecond), focused ultrasound pulses designed to induce controlled acoustic cavitation at a known focal location in the form of a "bubble cloud". The bubble cloud is a cluster of microbubbles that form, rapidly expand and collapse, imparting significant stress and strain on soft tissue, including liver tissue. After an adequate number of pulses (less than a few seconds at each bubble cloud location), liver tissue within the bubble cloud is mechanically destroyed, resulting in an acellular lysate with limited to no recognizable cellular structures. Acoustic cavitation (and bubble cloud formation) is only created when there is sufficient negative pressure to exceed the cavitation threshold, making it a threshold phenomenon.
The System is comprised of reusable medical equipment and disposable, single-patient use components intended for use in a professional healthcare environment. Reusable portions of the system include the Treatment Cart and a Support Arm and frame that is used to contain ultrasound medium (degassed water) that acoustically couples the system to the patient. Disposable aspects of the system include a clear, acoustically transparent and deformable membrane that holds the ultrasound medium as well as various non-active accessories used during patient set up. The Treatment Cart includes a Treatment Arm/Micropositioning System which is comprised of a six degree of freedom (6 DOF), dual encoded robotic arm. At the end of the arm is the Treatment Head which contains the histotripsy therapy transducer and a coaxially aligned diagnostic ultrasound probe. System software controls the Treatment Arm to direct the bubble cloud through the planned treatment volume.
The System is functionally integrated with a GE LOGIQ E10s ultrasound system (K231989), which is provided by HistoSonics with each Edison System.
## 6. Summary of Characteristics Compared to Predicate Devices
The Edison System under review is substantially equivalent to the Edison System cleared under K233466. The Edison System has the same technological characteristics as the predicates, that is, they operate in the same manner through the non-thermal, mechanical destruction of liver tumors by using non-invasive focused ultrasound.
Overall, the subject and primary predicate devices are all based on the same technological aspects as follows:
- equivalent core histotripsy parameters or dose
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- . no increase in the level or amount of focused ultrasound energy delivered
- . same thermal cooling table applied
The following primary technological differences exist between the subject and predicate devices:
- Larger bubble cloud volume of ~4x4x8mm (subject device) versus a ~3x3x11mm (predicate device) via the use of rapid electronic micro-steering.
- . 3cm diameter sphere treated with the predicate device would take a minimum of 13 minutes while the subject device will take a minimum of approximately 10-12 minutes.
- . The above enhancements are enabled through the implementation of a 128 channel therapy transducer and corresponding generator.
| Characteristic | Edison System
(Predicate Device)
K233466 | Edison System
(Subject Device) |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Edison System | Same |
| Device Classification | Class II | Same |
| FDA Product Code | QGM | Same |
| Indication for Use | The Edison System is indicated
for the non-invasive destruction
of liver tumors, including
unresectable liver tumors using
a non-thermal, mechanical
process of focused ultrasound. | Same |
| Anatomical Site | Liver | Same |
| Use Environment | Professional Healthcare
Environment | Same |
| Software Version | 2.1.2 | 3.0.1 |
| Integrated
Diagnostic
Ultrasound System | GE LOGIQ E10s (K211524) | GE LOGIQ E10s (K231989) |
| Treatment Cart | | |
| Generator | 64-channel amplifier | 128-channel amplifier |
| High Voltage Power
Supply | 10 amp max current (3.5 amp
average draw) power supply | Same |
| Power Distribution
Box | 1U Rackmount, 12V power
supply | Same |
| Uninterruptable
Power Supply (UPS) | 1U Rackmount, 770 Watt output
with 120V AC input | Same |
| Characteristic | Edison System
(Predicate Device)
K233466 | Edison System
(Subject Device) |
| Required Workflow | | |
| System Setup | Required steps include Log-in,
Position Treatment Arm,
Attach/Select Treatment Head,
Position Imaging Probe,
Submerge Treatment Head,
Calibrate Crosshairs, and Patient
Registration | Same |
| Patient Preparation
(Localize) | Required steps include Patient
Preparation, Patient Coupling,
Wheel Lock and Calibrate
Resistance Detection | Same |
| Plan | Required steps include Position
Contours, Verify Set-up by
surveying the plan to assure
that the resistance is
acceptable, Mark Muscle Layer
and Verify Plan | Same |
| Treat | Required steps include Calibrate
Crosshairs In Vivo, Establish
Voltage Settings and Automated
Treatment | Same |
| System Shutdown | Required steps include Remove
Treatment Head and Move
Treatment Arm to Storage
position | Same |
| Optional Workflow | | |
| DICOM Image
Viewer | IMFusion Software v2.45.15 | IMFusion Software v2.45.34 |
| Image Fusion
Workflow | Workflow steps include Breath
Hold and Image Sweep,
Review/Trim recording,
Establish Registration Points,
Fuse and Review/Accept Results | Same |
| Characteristic | Edison System
(Predicate Device)
K233466 | Edison System
(Subject Device) |
| Treatment Head | | |
| Treatment Heads
Available | 2 – 52 element and 56 element
(2 depths – 12cm and 14cm max
treatment depths) | 2 – both are 128 element, 2
depths (12cm and 14cm max
treatment depths) |
| Integrated
Diagnostic
Ultrasound Imaging
Probe | GE C1-6VN-D | Same |
| Imaging Probe
Rotation | +/- 180 degrees in X/Y | Same |
| Imaging Probe
Translation | + 5cm translation in Z | Same |
| Imaging Probe
Mounting | Coaxial | Same |
| Imaging refresh
rate | Continuous, Live stream | Same |
| Histotripsy Therapy Parameters | | |
| Bubble Cloud Size | ~3x3x11mm | ~4x4x8mm |
| Treatment plan size
range | • no more than a 1.5:1 ratio
from largest to smallest
diameter
• no less than 20 mm in any
diameter (X, Y, Z)
• no more than 40 mm in any
diameter (X, Y, Z) | • no more than a 2:1 ratio
from largest to smallest
diameter.
• no less than 15 mm in any
diameter (X, Y, Z).
• no more than 40 mm in any
diameter (X, Y, Z). |
| Focal Steering -
Static Focus | Static Focal Steering to achieve
1 cm to 2 cm extended depth
from natural focus | Not utilized |
| Focal Steering -
Rapid electronic
micro-steering | Automated Focal micro-steering
to achieve larger bubble cloud | Same |
| Thermal Profile | Thermally-safe treatment
protocol embedded in software | Same |
| Minimum
treatment time for
3cm Diameter
Sphere | ~13 min | ~10-12 min |
| Characteristic | Edison System
(Predicate Device)
K233466 | Edison System
(Subject Device) |
| Accessories / Patient Coupling Solution | | |
| Support Arm with
attached bedrail
clamp and
upper/lower frame | 3DOF, multi-joint arm
1′ bedrail clamp
Molded Frame components | Same |
| Patient membrane | Proprietary Styrene-ethylene-
butylene-styrene (SEBS)
membrane overmolded on
molded polypropylene frame | Same |
| Patient/Membrane
Coupling Oil | Castor Oil | Same |
| Membrane Cradle | Silicone web | Same |
| Bubble Evacuation
Tool | Custom molded bulb and tube
design | Same |
| Inspection Mirror | Included | Same |
| Ultrasound
Coupling Media | Degassed Water | Same |
See table below for a detailed summary of the characteristics compared to the predicate device.
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The bench and in-vivo animal study conducted demonstrate that the minor technological differences do not raise any different questions of safety and effectiveness and the subject device is as safe and effective as the predicate devices. In conclusion, the Edison System under review is substantially equivalent to the predicate device.
#### 7. Performance Data
In accordance with the required device Special Controls, non-clinical performance testing was performed on the modified Edison System which demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents. The following performance data was provided in support of the substantial equivalence determination.
## Design Verification and Validation Testing Data:
Design verification and validation testing was conducted and demonstrated that the Edison System meets defined product specification and its intended use. The design verification and validation testing included:
- . Electrical Safety testing in accordance with IEC 60601-1:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
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- . Electromagnetic disturbance testing in accordance with IEC 60601-1-2:2020 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
- . Acoustic Characterization in accordance with IEC 60601-2-62:2013 Medical electrical equipment- Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment.
- . Software Testing in accordance with ISO 62304:2015 Medical device software – Software life cycle processes.
- . System and Sub-system Verification Testing
## Cybersecurity Compliance Information:
Information demonstrating compliance with section 525B of the FD&C Action per current "FDA Guidance: Cybersecurity in Medical Devices - Quality System Considerations and Content of Premarket Submissions" is provided in this submission.
## Animal Study Data:
A GLP compliant preclinical study was conducted in a porcine model undergoing histotripsy procedure utilizing the reference device and modified Edison System. All acceptance criteria were met. Therefore, the design of the modified Edison System meets the intended use. The results from the testing demonstrate that the subject device does not raise any different questions of safety and effectiveness.
## Additional Considerations Specific to Special Controls:
There have been no device changes that impacted the critical tasks associated with the modified Edison System and therefore the previously conducted usability testing in accordance with ISO 62366-1:2020 Medical devices – Part 1: Application of usability engineering to medical devices is still applicable.
Finally, there have no changes to the patient contacting accessories that would impact the devices compliance with the following standards:
- . ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing;
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro ● cytotoxicity;
- . ISO 10993-10:2021 Biological evaluation of medical devices -- Part 10: Tests for skin sensitization;
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- . ISO 10993-23:2021 Biological evaluation of medical devices -- Part 23: Tests for irritation; and
- . FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 8, 2023.
## 8. Substantial Equivalence Discussion
The Edison System under review has the same intended use, indications for use, anatomical site, and principle of operation, and equivalent technological characteristics as the predicate device identified in this submission.
Furthermore, the design verification and validation testing performed demonstrate the subject device meets defined product specification and intended use. In addition, the bench and GLP animal comparison testing with the reference device demonstrate that the subject device has comparable performance to the predicate device and the minor technological characteristic differences do not raise any different questions of safety and effectiveness.
Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate device, the Edison System has been shown to be substantially equivalent to the predicate device identified in this submission.
---
**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QGM/K241902](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QGM/K241902)
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