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.
Decoding the legal framework for faster time-to-market.
The convergence of gamification and AI heralds a transformative era in mental health care, offering a blend of engagement and precision previously unattainable.
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.
Megan Coder, Vice President for Product and Policy at the Digital Medicine Society (DiMe), discusses the society’s new project aimed at researching global regulations for digital health to create a foundation for approval and patient access that can cut across regions.
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.
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.
Unhappy with current textbooks and resources for regulatory professionals, Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston Scientific, authored his own book for industry and future regulators.
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.
Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.
