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

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

In a world where technology is rapidly advancing, it is no surprise that the healthcare industry has also been greatly impacted by the rise of health tech innovations. From wearables to artificial intelligence (AI), these advancements have the potential to greatly improve patient care and outcomes. In this edition of STAT’s Health Tech, we take a closer look at the latest developments in the field.

One of the most talked-about topics in health tech is the use of AI in medical devices. While AI has the potential to revolutionize healthcare by providing faster and more accurate diagnoses, there are concerns about the safety and effectiveness of these devices. As such, the US Food and Drug Administration (FDA) requires all medical devices to undergo a pre-market review before they can be sold in the market.

However, AI startup, Gauss Surgical, is pushing for some AI-powered medical devices to be exempt from this pre-market review. The company has developed a device called Triton, which uses AI to monitor blood loss during surgery. According to Gauss Surgical, the device has been used in over 10,000 surgeries without any adverse events. They argue that the pre-market review process is lengthy and costly, and it could hinder the development and adoption of life-saving technologies like Triton.

The FDA has recently announced that it will be holding a public meeting to discuss the potential changes to its regulatory approach for AI-powered medical devices. This move has been welcomed by the health tech industry, as it shows the FDA’s willingness to adapt to the changing landscape of healthcare technology. With more discussions and collaborations between regulators and innovators, we can hope to see a more streamlined and efficient process for the approval of AI-powered medical devices.

In other health tech news, Verily, a subsidiary of Alphabet (Google’s parent company), has announced its plans to develop a new type of contact lens that can detect glucose levels in tears. This technology could greatly benefit people with diabetes, as it eliminates the need for finger pricking to check blood sugar levels. Verily has partnered with Alcon, a division of pharmaceutical giant Novartis, to bring this innovative device to market.

Another exciting development in the health tech industry is the use of virtual and augmented reality in healthcare. This technology has the potential to improve medical training, patient education, and even pain management. The University of California, Los Angeles (UCLA) is currently conducting a study on the use of virtual reality to treat chronic pain. The initial results have been promising, and if successful, this could be a game-changer for patients suffering from chronic pain.

On the electronic health record (EHR) front, Eko, a digital health company, has received FDA clearance for its AI-powered EKG analysis software. This software has the ability to detect heart murmurs and atrial fibrillation, which could greatly benefit patients with heart conditions. With the incorporation of AI in EHRs, healthcare providers can expect to see more accurate and timely diagnosis, leading to better treatment outcomes.

Lastly, health tech companies are also exploring the use of blockchain technology in healthcare. Blockchain has the potential to improve data security and interoperability, ultimately leading to better patient care. Medicalchain, a UK-based startup, has recently launched a telemedicine platform that uses blockchain technology to securely store and share patient data. This could greatly benefit patients who need to access medical care remotely.

In conclusion, the health tech industry is constantly evolving, and these latest developments show that we are moving in the right direction. From the use of AI in medical devices to the incorporation of virtual reality in healthcare, these advancements have the potential to greatly improve patient outcomes. It is encouraging to see the FDA’s willingness to adapt to these changes and work towards a more efficient regulatory process. With continued innovation and collaboration, we can expect to see more life-changing technologies in the field of health tech.

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