Saturday, February 28, 2026

STAT+: An AI startup floats FDA deregulation, using an obscure backdoor

In the fast-paced world of healthcare technology, it seems like there’s always something new and exciting on the horizon. But in this edition of STAT’s Health Tech, we’re taking a closer look at one company’s push for some AI-powered medical devices to be exempt from pre-market review, as well as other noteworthy health tech news.

At the forefront of this discussion is a startup called Viz.ai, which specializes in developing artificial intelligence (AI) technology for medical imaging. Their flagship product, Viz LVO, uses AI algorithms to analyze brain scans and identify signs of a potentially life-threatening stroke. This revolutionary technology has already been approved by the US Food and Drug Administration (FDA) and has shown promising results in clinical trials.

Now, Viz.ai is pushing for some of their AI-powered devices to be exempt from pre-market review, citing the potential benefits for patients and healthcare providers. The company argues that the current regulatory process can be lengthy and expensive, delaying the availability of life-saving technology to those who need it most. By exempting some devices from pre-market review, Viz.ai hopes to streamline the process and get their technology into the hands of healthcare professionals more quickly.

While some experts have raised concerns about the safety and efficacy of AI-powered medical devices, Viz.ai maintains that their technology has undergone rigorous testing and meets all necessary standards. In fact, the company has already received the highest level of regulatory clearance for their Viz LVO device, known as a De Novo classification.

But it’s not just Viz.ai making waves in the health tech world. Other companies are also making strides in the development of AI-powered devices and software. For example, Google’s DeepMind Health recently announced a partnership with the UK’s National Health Service (NHS) to develop AI technology for early detection of eye diseases. This collaboration has the potential to greatly improve the accuracy and speed of eye disease diagnoses, ultimately leading to better patient outcomes.

In addition to AI technology, virtual and augmented reality (VR/AR) are also making their mark in the healthcare industry. VR/AR has the potential to revolutionize medical training, patient education, and even pain management. For example, VR technology has been used to help patients with chronic pain by distracting them from their discomfort and reducing their need for pain medication.

Another noteworthy development in the health tech world is the rise of telemedicine. With the increasing use of smartphones and other devices, telemedicine allows patients to connect with healthcare professionals remotely, making healthcare more accessible and convenient. This has been particularly beneficial for patients in rural or underserved areas, as well as those with limited mobility or transportation options.

However, with all these exciting advancements in health tech, it’s important not to overlook potential challenges and ethical considerations. The use of AI and other technology in healthcare raises questions about data privacy, liability, and the potential for bias in algorithms. These are important issues that must be addressed as the use of technology in healthcare continues to expand.

Overall, the health tech industry is constantly evolving and pushing the boundaries of what is possible in healthcare. From AI-powered devices to VR/AR technology, these advancements have the potential to greatly improve patient outcomes and revolutionize the way we approach healthcare. However, it’s crucial that these developments are carefully regulated and ethically implemented to ensure the safety and well-being of patients.

So while we keep an eye on the latest developments in health tech, let’s also remember to consider the potential impact on patients and the greater healthcare system. With responsible innovation and collaboration between industry leaders and regulatory bodies, we can continue to push the boundaries and improve the lives of patients around the world.

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