EU Approves First AI For Analyzing X-Rays Automatically

EU Approves First AI For Analyzing X-Rays Automatically

ChestLink, an autonomous AI imaging suite by medical imaging company Oxipit, was created to exist alongside medical professionals “as an integral part of the clinical workflow.” ChestLink can scan X-rays for abnormalities and send patients reports when their X-rays appear normal. When the tool encounters a potential health concern, it sends the X-ray to a radiologist for manual review. If there’s any “doubt” from the AI that a patient’s X-ray may feature abnormalities, it sends that X-ray to a radiologist as a precautionary measure to ensure hidden health issues don’t slip through the cracks.

Oxipit received CE mark certification for the tool last week, classifying ChestLink as a class IIb health device (on par with a ventilator or any intensive care monitoring equipment) found to comply with all relevant EU legislation. The company plans on certifying ChestLink through the Food and Drug Administration (FDA) as well for eventual use in the United States.

Before it was certified, ChestLink spent more than a year reviewing 500,000 real X-rays across multiple pilot locations. “The sensitivity metric of 99 percent has translated to zero clinically relevant errors at our deployment institutions during the application piloting stage,” Oxipit CEO Gediminas Peksys said in a release.

EU Approves First AI For Analyzing X-Rays Automatically

ChestLink’s first clinical deployment is slated for early 2023. For safety and certainty’s sake, Oxipit will start out by assigning ChestLink retrospective analyses—AKA X-rays that radiologists have already reviewed. Once the tool passes that real-world test, ChestLink will be used for preliminary analyses under supervision by Oxipit and medical institution staff. The final stage of deployment will move ChestLink into autonomous prospective reporting as designed. In the rare case that a radiologist may need to manually review a patient’s X-ray after ChestLink gave them a clear bill of health, staff will be able to quickly trace the steps of application decisions through a real-time analytics page.

Oxipit states ChestLink will be particularly convenient in primary care offices, where around 80 percent of all X-rays turn up normal. The time saved is intended to be spent on direct patient care. Given a widespread concern among radiologists that their profession could become fully automated, technology like Oxipit’s has been contested for quite some time. Oxipit and some experts say it’s more likely that AI will continue to assist and improve healthcare instead of replacing people entirely—despite mathematical proof that AI tends to outperform human radiologists. But as Oxipit itself says, “it’s not a question of mathematical performance” when AI capabilities and human expertise can be combined.

Continue reading

FDA Approves New Eye Drops that Could Replace Glasses for Millions
FDA Approves New Eye Drops that Could Replace Glasses for Millions

A first-of-its-kind type of eye drop offers the tantalizing benefit of never needing reading glasses ever again.

Kids 5-11 Approved For COVID-19 Boosters
Kids 5-11 Approved For COVID-19 Boosters

Though children overall have been less susceptible to contracting COVID-19 since the pandemic began, the new(ish) omicron variants are highly transmissible, increasing everyone’s risk of infection.

SpaceX Seeks FCC Approval for 1 Million Earth-Based Satellite Uplinks
SpaceX Seeks FCC Approval for 1 Million Earth-Based Satellite Uplinks

SpaceX is asking the FCC to approve its application quickly in light of it's "ambitious timetable for launching satellites and deploying broadband services."

Elon Musk in Trouble: No Grownup Pre-Approved His Tesla Production Tweet
Elon Musk in Trouble: No Grownup Pre-Approved His Tesla Production Tweet

Tesla and Elon Musk agreed in a 2018 consent decree that a Tesla committee had to approve his tweets in advance. On his own, Musk last week tweeted Tesla would make 500K cars in 2019, then later said they'd deliver 400K.