Welcome to Stethophone

You are currently viewing the US version of this website. The regulation of medical devices is specific to each country. This website contains information about products that may not be available in all countries, or may be available under different trademarks or for different indications and audiences.

Currently different versions of Stethophone are recognized as a medical device in the USA, Canada, and Ukraine. This means that Stethophone is available for residents of these countries. We are working on offering Stethophone in more countries in the future.

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What USA health standards/guidelines does Stethophone Pro AI comply with?

Updated

Only FDA-cleared medical devices can enter the USA market. FDA has cleared Stethophone Pro and confirmed it meets the regulatory requirements for safety, cybersecurity, and effectiveness. After receiving the regulatory go-ahead, we adhere to post-market surveillance requirements. We also confirm our HIPAA and ISO 13485:2016 certification annually.

Stethophone Pro is developed and maintained in conformity with many international and USA standards, guidelines, and requirements to ensure that our medical device delivers the best user experience.