AI-Powered Teleradiology FDA Cleared for Triage in Departments Swamped by COVID-19

By Conn Hastings at Medgadget

Nines, a teleradiology company based in Palo Alto, CA, recently received FDA clearance for their NinesAI medical device, which supports the automated radiological review of CT Head images for the possible presence of two time-critical, life-threatening indications: intracranial hemorrhage and mass effect. The technology can help radiologists in triaging cases. Nines is the first company to receive FDA clearance for AI technology that triages mass effect conditions.

Teleradiology is an increasingly vital service for healthcare providers, whereby radiological images are sent to a radiologist in a remote location for analysis. Moreover, AI has an emerging role in radiological diagnostics, and can provide a supportive role for radiologists in making their assessments.

All current customers and new customers who sign up with Nines before June 30, 2020 will get NinesAI for free. This access will allow Nines’ customers to assess, identify, and triage emergent conditions of intracranial hemorrhage and mass effect while in-house radiology departments are inundated, especially as some of these departments are overwhelmed by COVID-19 cases.

Medgadget had the opportunity to speak with David Stavens, CEO and co-founder of Nines, about the technology, and how the company is supporting quality care and radiologists in a time where hospitals and healthcare providers are resource-constrained.

Stavens has an interesting background in AI, having been involved in the world’s first robotic car “Stanley” as a co-founder of Stanford’s self-driving team, which became the foundation for Waymo, which was acquired by Google, itself part of Alphabet. He later co-founded and was CEO of online learning platform Udacity.

Conn Hastings, Medgadget: Please give us an overview of your background in AI.

David Stavens, Nines: I’ve loved computers since I was very young. I remember receiving my first Apple IIGS for Christmas in the late 1980s and learning to write computer software soon thereafter. It was unusual in those days for kids to be into computers and coding. As I got older, I recognized that computers and software were not only fun hobbies, but an exciting way to make a broader impact in the world.

I am drawn to important humanitarian problems and how they could be solved using computer technology. As co-founder and CEO of Udacity, Sebastian Thrun and I worked to use the web to make world class education and great jobs available to everyone in the world. Prior to that, we worked on building one of the first self-driving cars while at Stanford, which eventually became Waymo.

Self-driving technology has the potential to save many of the 40,000 lives lost every year in the U.S. due to traffic accidents, improving mobility for those with visual or neuromotor impairment, and making longer drives more pleasant for everyone. At Nines, we believe that radiology can be made even better for radiologists and patients using technology and we are excited to help bring that change about.

Medgadget: What inspired you to start Nines?

David Stavens: Our health is one of our most precious assets — a point made even more pronounced with the onset of COVID-19. But navigating the healthcare system is very complex, especially for those without insurance or those who do not live in an industrialized country. Access to timely, affordable,high quality care should be universal. At Nines, we believe that radiology can be made even better for radiologists and patients using technology and telehealth and we are excited to help bring that change about. The adoption of telehealth has only become more essential and prevalent in the time of COVID-19.

The use of medical imaging, such as MRI, CT and ultrasounds performed in healthcare facilities, has continued to rise, according to the Journal of American Medical Association in analyzing trends from seven integrated U.S. healthcare systems. These scans are not only increasing in number, but also in complexity — scans include more images and the images are of higher resolution.

According to the American College of Radiology, there is only one radiologist for every 10,000 Americans. To keep up, a typical radiologist must review one image every three to four seconds to meet workload demands in an 8 hour workday, according to a study from the Mayo Clinic. Each one of those images has the potential to show information that is critical in making a radiologic diagnosis that is used to direct patient care.

Nines is building world class technology to help. NinesAI is FDA-cleared and supports the automated radiological review of CT Head images for the possible presence of two time-critical, life-threatening indications – intracranial hemorrhage and mass effect – to aid radiologists in triaging cases and identify them more rapidly. In an emergency room late at night, an actionable report turned around quickly could give patients a reliable and speedy diagnosis and could calm worries about what is wrong.

Medgadget: Please give us an overview of the teleradiology services provided by Nines.

David Stavens: Nines is a teleradiology practice that pairs world-class radiologists with fantastic engineers and product managers to deliver high quality medical care accelerated by advanced technology.Hospitals and medical practices can choose Nines to read some volume of their radiology studies, for example on nights or weekends when they have fewer radiologists on call. With engineers and physicians side-by-side, technology and process improvements occur rapidly for the benefit of physicians, hospitals, medical practices, and patients.

For example, on average, a radiologist is interrupted about five times an hour, whether answering phone calls or coordinating with colleagues, which increases exam interpretation times, according to the Journal of Academic Radiology. At Nines, radiologists and engineers have worked together to develop the Nines Navigator™ worklist and the Nines Reading Assistant. These are administrative, non-medical device programs that aggregate clinical information and surface custom-built tools to improve radiologist focus. This includes listing relevant patient info and easier communication with hospital physicians interacting with the patients. Together with NinesAI, these tools assist Nines radiologists with providing timely, quality care.

Medgadget: How has the COVID-19 pandemic affected the services you offer and the clients you work with?

David Stavens: COVID-19 has placed unprecedented strain on all aspects of the U.S. healthcare system. We are offering in-house access to the NinesAI technology free of charge for new and existing Nines Radiology customers who sign up by June 30, 2020. Some healthcare providers are seeing early indications of a potential relationship between COVID-19 and an increase in the number of strokes in some younger patients. Stroke is one cause of intracranial hemorrhage and mass effect, the two conditions NinesAI detects. In addition, NinesAI improves radiology efficiency through triaging emerging studies, which we believe will be particularly helpful as radiologists are under strain at this time.

Medgadget: What are the strengths of AI in radiological analysis?

David Stavens: For emergent conditions of ICH and mass effect, time to intervention is critical. With intracranial hemorrhage for example, the 30-day mortality rate ranges from 35% to 52% with only 20% of survivors expected to have full functional recovery at 6 months, and approximately half of this mortality occurs within the first 24 hours.

Radiologists using NinesAI can be notified of a potential life-threatening finding in approximately 15 seconds after image acquisition is complete, meaning that potentially life-saving care can begin very quickly. The standard-of-care without AI is to read studies in the order in which they were received. We believe the role of artificial intelligence for radiology is to make radiologists’ lives better as an assistive technology that supports their service and prioritization of the patients who need care most urgently.

Medgadget: Please tell us about these most recently approved AI-powered teleradiology services.

David Stavens: At the end of April, we received unprecedented U.S. Food and Drug Administration clearance for artificial intelligence technology that triages intracranial hemorrhage and mass effect conditions on non-contrast CT scans of the head. Our NinesAI medical device supports the automated radiological review of images from these scans for the possible presence of these two time-critical, life-threatening indications to aid radiologists in triaging cases. We are proud to be the first company to receive FDA clearance for artificial intelligence technology that triages mass effect conditions and to our knowledge, the first company to receive simultaneous FDA clearance on multiple indications.

Original news can be found here.