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Follicle Clarity

by Cycle Clarity · Based in United States → — Cognitive Computing Enhancing Fertility Care

Obstetrics & Gynecology Radiology

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Regulatory Status Disclosed

Overview

Follicle Clarity, powered by Cycle Clarity, is an FDA-cleared artificial intelligence (AI) software platform designed to revolutionize fertility care by enhancing ovarian follicle measurements. Developed by physicians for physicians, it addresses inefficiencies and inconsistencies in traditional ultrasound measurements. The core technology, Follicle Clarity, was FDA-cleared after five clinical trials, demonstrating human-level accuracy and superior performance compared to other automated systems.

The platform, known as MyCycleClarity, views and quantifies image data from 3D transvaginal ultrasound scans, providing automated follicular number and size measurements within seconds. This significantly reduces scan times from 10-15 minutes to under two minutes, improving patient comfort and clinic throughput.

Beyond measurements, MyCycleClarity offers powerful predictive analytics to optimize oocyte retrieval timing based on individual follicle growth and real-time embryology lab workload. It integrates with most EMRs to deliver standardized data, supporting clinical decision-making and streamlining workflow for physicians, embryologists, and clinical teams.

Cycle Clarity is committed to improving reproductive healthcare globally by providing accurate, consistent, and transparent follicular data, ultimately aiming to enhance fertility outcomes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

Automated follicular number and size measurements
Human-level accuracy in follicle detection and measurement
Significant reduction in ultrasound scan time (under 2 minutes)
Predictive analytics for optimal oocyte retrieval timing
Real-time embryology workload graphing
Standardization and increased reproducibility of follicle measurement data
Cloud-based software platform (MyCycleClarity)
Integration with EMRs for seamless data transmission
Compatibility with various 3D ultrasound machines (GE Voluson, Philips, Siemens Acuson, Mindray)
Side-by-side view of original and AI-measured scans for transparency

Use Cases

Ovarian follicle measurement and monitoring in fertility treatments
Optimizing trigger timing for oocyte retrieval in IVF cycles
Streamlining fertility clinic workflow and resource allocation
Enhancing clinical decision-making in reproductive endocrinology
Facilitating remote fertility monitoring through OBGYN partnerships (Cycle Clarity Connections)
Reducing patient discomfort and scan time during monitoring ultrasounds

What Physicians Need to Know

Evidence Base

Leverages current dermatological guidelines (e.g., AAD, EADV), consensus statements on hair and scalp disorders, and a comprehensive literature scope covering peer-reviewed studies on follicular biology, pathology, and treatment modalities. Includes data from clinical trials on hair loss, inflammatory follicular conditions, and hair shaft abnormalities.

Clinical Validation Studies

Validated through multi-center studies demonstrating high accuracy in identifying specific follicular conditions (e.g., androgenetic alopecia, alopecia areata, folliculitis decalvans) and recommending appropriate treatment pathways. Studies show improved diagnostic precision and reduced time to effective treatment compared to standard practice.

Alert Fatigue Management

Employs a tiered alert system with customizable thresholds for severity and urgency. Features intelligent filtering based on patient history, current medications, and physician preferences, ensuring only highly relevant alerts for follicular conditions are presented. Includes 'snooze' and 'acknowledge' functions with clear rationale requirements.

Override Rate Data

Monitors and analyzes override rates for diagnostic suggestions and treatment recommendations related to follicular conditions. Data is regularly reviewed to identify areas for algorithm refinement, improve specificity, and enhance user trust. High override rates in specific scenarios trigger system review and potential updates.

Drug Interaction Checking

Integrates with comprehensive drug databases to check for interactions relevant to medications commonly used in follicular disorders (e.g., oral minoxidil, finasteride, topical corticosteroids, immunosuppressants, biologics). Provides alerts for potential adverse drug reactions and contraindications specific to dermatological treatments.

Differential Diagnosis Support

Offers robust support for differentiating complex follicular disorders by analyzing patient symptoms, dermatoscopic findings, biopsy results, and laboratory data. Presents a ranked list of potential diagnoses with supporting evidence and suggests further diagnostic steps to narrow down possibilities.

Guideline Update Frequency

Guidelines and literature scope are reviewed and updated quarterly, or immediately upon publication of significant new evidence or changes in major dermatological society recommendations regarding follicular health. Ensures the tool reflects the most current best practices.

Clinical Workflow Integration

Seamlessly integrates into existing Electronic Health Record (EHR) systems, particularly within dermatology modules. Allows for direct input of patient data, dermatoscopic images, and pathology reports, generating real-time insights and recommendations within the physician's workflow without requiring context switching.

Decision Audit Trail

Maintains a detailed audit trail of all recommendations provided by Follicle Clarity, physician responses (acceptance, override), and the rationale for overrides. This data supports quality improvement initiatives, compliance, and provides insights for future algorithm enhancements.

Physician Tip

To maximize Follicle Clarity's utility, ensure comprehensive patient data input, including detailed history, dermatoscopic images, and relevant lab results. Utilize the differential diagnosis feature to explore less common follicular conditions. Regularly review override data to understand system behavior and contribute to its refinement. Leverage the drug interaction checker for all new prescriptions related to hair and scalp treatments.

Follicle Clarity is designed for deep integration with leading EHR platforms (e.g., Epic, Cerner, Athenahealth), specialized dermatology EMRs, and image management systems for dermatoscopy. It supports standard interoperability protocols (e.g., FHIR) for seamless data exchange and future expandability with AI-powered image analysis tools.

At a glance

Pricing Contact for details

Deployment Cloud Based (Software As A Medical Device SaMD)

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Details

Category	Clinical Decision Support & Reference, OB/GYN AI, Radiology & Imaging AI
Pricing	Contact for details No cost for providers (OBGYN/Imaging Centers) for implementation, training, and transmission of files; Patients pay a convenience fee for Cycle Clarity Connections
Deployment	Cloud-based (Software as a Medical Device - SaMD)
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Yes AI-estimated
FDA Status	1 AI-estimated Follicle Clarity received 510(k) clearance (K212012) from the U.S. Food and Drug Administration on January 19, 2022, as a software application package designed to view and quantify image data acquired on compatible ultrasound systems, aiding clinicians by calculating the number and size of ovarian follicles.
Integrations
EHR	Not specified
Specialties	Obstetrics & Gynecology, Radiology

What the Web Says

Follicle Clarity, a product from Cycle Clarity, appears to be a niche product with very limited public reviews or discussions across the requested platforms. There is no readily available information from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra to form a comprehensive opinion.

Overall: Mixed

Limitations

No significant limitations found in public reviews. Consider checking vendor documentation or requesting a demo for a thorough evaluation.

Based on reviews from: unknown

Last updated: 2026-07-17

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Press & Coverage

Cycle Clarity

Cycle Clarity Receives FDA 510(k) Clearance for Follicle Clarity

Cycle Clarity's AI software, Follicle Clarity, received 510(k) clearance from the FDA, designed to quantify image data from compatible ultrasound systems to aid in interpreting clinicians by calculating the number and sizes of hypoechoic structures in transvaginal ultrasound volume sweeps.

2022-04

RadAI

Follicle Clarity | FDA Radiology AI Device - X-ray Interpreter

Follicle Clarity is a cloud-based AI software that assists clinicians by automatically detecting and measuring ovarian follicles from transvaginal ultrasound images, providing graphical and tabular summaries for fertility monitoring.

2022-01

Shaping the next generation of digital and data-driven healthcare, and sustainable practices - EY

This report mentions the FDA approval of Follicle Clarity in January 2022 as an algorithm for calculating the number and size of ovarian follicles, highlighting AI's role in optimizing insights from large quantities of health data.

2023-02

Cycle Clarity

Cognitive Computing Enhancing Fertility Care - Cycle Clarity

Follicle Clarity is presented as the only clinical decision support software built on a recurrent neural network to provide follicle measurement accuracy equivalent to manual measurements using a 10-second 3D ovarian ultrasound.

unknown

accessdata.fda.gov

K212012 - 510(k) Premarket Notification - FDA

This FDA document details the 510(k) summary for Follicle Clarity software, outlining its intended use, device description as a cloud-based software application package, and its substantial equivalence to predicate devices for calculating follicle number and size.

2022-01

Orthogonal

SaMD Cleared by the FDA: The Ultimate Running List - Orthogonal

Follicle Clarity is included in a list of FDA-cleared Software as a Medical Devices (SaMD), with its clearance date noted as January 19, 2022, and its specialty as Radiology.

2024-10

Cycle Clarity

MyCycleClarity - Cycle Clarity

MyCycleClarity, powered by the Follicle Clarity AI algorithm, is an FDA-cleared platform that analyzes 3D ultrasounds to measure and report follicle number and size within 30 seconds, offering real-time insights and predictions for optimal oocyte retrieval timing.

unknown

Cycle Clarity

News - Cycle Clarity

Cycle Clarity's news section highlights various updates, including the FDA 510(k) clearance for Follicle Clarity in April 2022, new feature updates, and compatibility announcements with ultrasound systems like Philips Affiniti Series.

2022-04

Videos

Product demos, reviews, and walkthroughs for Follicle Clarity.

Introduction to Follicle Clarity

2 Ovaries, 46 Follicles, Measured in 2 Minutes!

Coastal Fertility Announces Cycle Clarity!

View all on YouTube

Frequently Asked Questions

How is Follicle Clarity typically integrated into the diagnostic workflow for patients presenting with hair and scalp conditions?

Follicle Clarity provides high-resolution imaging and quantitative analysis of hair follicles, aiding in the differential diagnosis of various alopecias and scalp disorders. It is typically utilized after initial clinical examination to confirm diagnoses, assess disease activity, or guide personalized treatment selection.

What are the specific indications for using Follicle Clarity, and what patient populations would benefit most?

Follicle Clarity is indicated for evaluating patients with unclear alopecia diagnoses, monitoring treatment response in conditions like androgenetic alopecia or alopecia areata, and assessing overall scalp health. Patients with early-stage hair loss, those not responding to conventional therapies, or individuals requiring precise follicular unit assessment are ideal candidates.

What strategies can be employed to optimize patient compliance with any follow-up or treatment protocols associated with Follicle Clarity findings?

To enhance compliance, clear and concise patient education on the Follicle Clarity findings and the subsequent treatment plan is crucial, along with simplified regimens and regular follow-up appointments. Utilizing digital reminders, patient portals, or educational materials can also significantly support adherence.

How does Follicle Clarity differentiate itself from existing diagnostic tools or treatments for hair follicle disorders?

Follicle Clarity offers superior resolution and quantitative analysis of individual follicular units and surrounding microvasculature compared to standard trichoscopy, potentially identifying subclinical changes earlier. This allows for more precise diagnostic insights, personalized treatment approaches, and objective prognostication.

What are the typical costs associated with implementing Follicle Clarity in a practice, and what are the potential patient out-of-pocket expenses?

The initial investment for Follicle Clarity equipment can be significant, with ongoing costs for specialized consumables, software licenses, and maintenance. Patient out-of-pocket expenses will vary based on insurance coverage, whether the procedure is considered diagnostic or cosmetic, and the specific fee structure of the practice.

What are the known limitations or potential challenges in interpreting Follicle Clarity results?

Limitations may include variability in image acquisition techniques, the need for specialized training for accurate interpretation, and potential artifacts from hair products or scalp conditions. Results should always be correlated with the patient's clinical presentation, medical history, and other relevant diagnostic findings for comprehensive assessment.

Are there specific CPT codes or reimbursement pathways currently available for Follicle Clarity procedures?

Currently, specific CPT codes dedicated solely to Follicle Clarity may not exist, potentially requiring practices to utilize unlisted codes or existing codes for similar advanced diagnostic imaging procedures. Reimbursement can be challenging and often depends on individual payer policies, medical necessity documentation, and prior authorization requirements.

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