Digital Health Roundup, July 2021: Exec Chat With DTA, Start-Ups Grab New Funds, Agency Nods

In this roundup feature focusing on the developments in digital health, we highlight the key news and announcements from July.

Digital Health Roundup
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With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

Ellipsis Raises $45M To Expand AI Care Manager Across Health Systems

 
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Ellipsis said it will use its new funding to expand its AI-powered voice assistant Sage across health systems. Ellipsis is part of the global vocal biomarker market, which is expected to exceed $9bn by the end of 2033, according to a research market report.

Sofinnova And NVIDIA Partner To ‘Supercharge’ Computation For European Startups

 

European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.

Somnee AI-Powered Sleep Wearable Raises $10M Seed Round

 

The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.

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A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

‘UK Must Put Adoption On A Par With Innovation’

 
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Market access concerns dominated at the annual BioWales In London event, where AstraZeneca set out industry’s priorities and the UK Office for Life Sciences struck an optimistic tone about how the UK will lastingly improve uptake of innovation.

Sofinnova And NVIDIA Partner To ‘Supercharge’ Computation For European Startups

 

European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.