Samd

Amalgam Rx develops and produces regulated Software as a Medical Device (SaMD) products and serves as the Manufacturer of Record for SaMD across the globe.

MDIC's Digital Health initiative focuses on the convergence of connectivity, information, and software in medical devices, including areas like Software as a Medical Device.

Huma received FDA Class II clearance for its disease-agnostic Software as a Medical Device (SaMD) platform, which is used for monitoring patients of all ages with any condition.

BrightInsight develops and produces Software as a Medical Device (SaMD), as evidenced by their development of 14 SaMD solutions.

Click Therapeutics develops and commercializes software as prescription medical treatments, operates as a regulated Software as a Medical Device (SaMD)-focused biotechnology company, and seeks FDA clearance for apps as class II medical devices.

Decisio Health develops InsightIQ, which is recognized as a Class II medical device by the FDA. This indicates that InsightIQ qualifies as Software as a Medical Device (SaMD).

Anumana develops and commercializes AI-driven software solutions that have received FDA clearance and Breakthrough Device Designation, indicating that these solutions are classified as Software as a Medical Device (SaMD).

Biotricity provides a digital health platform that integrates hardware with software solutions for real-time patient monitoring and data analytics, which qualifies as Software as a Medical Device (SaMD).

InformAI develops AI-driven enterprise software solutions targeting clinical needs in radiology, radiation oncology, and high acuity informatics, which includes products like RadOncAI, SinusAI, and TransplantAI. These products enhance healthcare quality, safety, and efficiency, indicating that they develop Software as a Medical Device (SaMD).