Frequently Asked Questions

• I received the Customer Advisory Notice; what product changes are included in the upcoming release?

  There will be three primary changes:

  1. New educational materials for patients will be available on Cleerlyhealth.com replacing the Patient Report, which will be discontinued
  2. The removal of the Atherosclerotic Staging System from the Provider Report
  3. A workflow modification for some customers utilizing Cleerly Services

• How can I determine if I will be affected by this update?

  All users of Cleerly LABS are potentially impacted by this notice. To identify if you, your practice, or workflow will be affected, please review the full changes outlined in the Customer Advisory Notice or watch our training video. To access the video, please use the link in the email sent from Cleerly Product Updates on January 29th. For additional assistance or to discuss changes specific to your workflow, please reach out to your Cleerly representative or email product_notice@cleerlyhealth.com to schedule a training session.

• When will these changes go into effect?

  The software and reporting changes are expected to go into effect in early March 2025.

• Are there any resources available for my team to learn about the software and reporting updates?

  Yes, our team is here to ensure this update is as smooth as possible for you. The Cleerly team sent two emails to customers on January 29th: One with the Customer Advisory Notice and, the second, from Cleerly Product Updates, with a link to all the informational materials for the software update. (Please search the subject line “Review New Cleerly Product Training” if you have any trouble locating it.) At that link you’ll find:

  • An instructional video on the workflow changes, including resetting your password and accepting Cleerly Analysis studies
  • The Customer Advisory Notice outlining these updates

   

  If you’d like to discuss changes specific to your workflow, please don’t hesitate to reach out to your Cleerly representative or email product_notice@cleerlyhealth.com to schedule a training session.

• Are there any safety concerns with using the current product?

  No, there are no safety or efficacy risks associated with continued use of Cleerly LABS software. We voluntarily initiated this advisory notice to ensure that we are aligned with our FDA clearance. You can continue to utilize Cleerly LABS; the software will perform as intended and designed by Cleerly.

• Will I still be able to access old Patient Reports after the March 2025 update?

  No, previously generated Patient Reports will be removed with the software release. As a reminder, all patient-specific images are still contained in the Provider Reports. Provider Reports generated after the release will include a QR code that links directly to educational material for patients, and is available on the Cleerly website.

• Will this affect Cleerly ISCHEMIA?

  No, the advisory notice only applies to the Cleerly LABS 2.0 product. There is no impact to Cleerly ISCHEMIA or any other Cleerly products or services.

• What’s included in the new patient education materials?

  The new patient education materials provide patients with useful explanations of coronary artery disease, coronary computed tomography angiography (CCTA), and Cleerly Plaque and ISCHEMIA. These materials will be available on Cleerlyhealth.com, you can use these materials in discussions with patients both before or after their Cleerly scans.