​HAS INVESTOR SCEPTICISM BEEN OVERPLAYED?

Elizabeth Holmes, the founder of bogus blood testing startup Theranos, has been sentenced to over 11 years in prison for defrauding investors. 

The conclusion to Silicon Valley’s so-called Trial of the Century — which spawned its own TV series, books and a dedicated podcast — serves as a warning to investors looking to back breakthrough technologies. Theranos was shut down in 2018 after employees blew the whistle on the company’s supposedly revolutionary technology that just didn’t work, but not before deal-hungry backers had pumped $900m into it. 

While the saga might have initially made VCs more wary of diagnostics startups, a recent Pitchbook report suggests that investor attitudes are shifting — a number of blood testing startups have picked up VC backing this year.

So how has Theranos’s downfall affected Europe’s diagnostics startups?

Sifted spoke to investors and founders in the sector to ask whether the fallout from the trial might have its positives, and what the future holds for the sector.

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​As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates.

As medical devices that use artificial intelligence and machine learning appear in more hospitals and imaging labs across the U.S., new data from the Food and Drug Administration show the agency has been fielding more submissions.
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In 2022 alone, the FDA authorized 91 AI- or machine-learning-enabled medical devices, according to data released on Oct. 5. This broad category of devices can include anything from a basic algorithm to more complex machine learning tools, Michaela Miller, U.S. medtech technology and analytics practice leader for IQVIA, a North Carolina-based analytics and clinical research firm, said by email. 

MedTech Dive analyzed FDA data on all of the AI- and machine-learning-enabled devices the agency has authorized to date. Follow this link to the full article to read the five takeaways on the rise of these devices.