Randy Horton
Randy Horton

FDA-Cleared SaMD by the Numbers

By Randy Horton

Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which companies are having the most success getting their products cleared for the U.S. market.

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Caroline Shleifer
Caroline Shleifer
Soapbox

Unlocking Success in SaMD Product Launches Through AI

By Caroline Shleifer

AI-driven regulatory platforms support SaMD organizations by proactively monitoring and adapting to the dynamic global regulatory landscape. The technology alerts users to anticipated regulatory updates worldwide, facilitating improved foresight and trend detection. It also provides guidance on addressing potential lapses in product compliance, integrates with existing workflows and streamlines regulatory tasks from classification to registration and market entry.

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Kaushik Gune
Kaushik Gune

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

By MedTech Intelligence Staff

This week Huma Therapeutics received FDA Class II 510(k) clearance for its Software as a Medical Device (SaMD) platform, potentially speeding approval of a variety of AI and machine-learning (ML)-powered digital health devices. We spoke with Kaushik Gune, U.S. Head of Healthcare at Huma, about the current state of digital health technologies, the value of partnerships to enhance the use of real world data and how digital health is likely to advance in the coming years.

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Binary code
Binary code
Soapbox

Automating Computer Systems Validation for Your QMS

By Davor Milosevic, Massimo Franza

Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.

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Lorenzo Gutierrez, Starfish Medical
Lorenzo Gutierrez, Starfish Medical

Integrating Games into Medical Devices To Improve Patient Outcomes

By Lorenzo Gutierrez

Imagine a patient undergoing therapy being relaxed and enjoying the treatment, or receiving rewards for taking medicine religiously and on time. Creating a game-like experience can change patient perception of medical devices from boring or scary to engaging and attractive. This article covers ways to integrate gaming features into your medical devices, why games are so enticing and how they impact human behavior. 

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