The top IVD and diabetes tech stories of 2023

The G7 CGM helps users manage their diabetes. [Image courtesy of Dexcom]Over the course of 2023, the medtech industry produced another impressive year of innovation, with news coming from a variety of spaces.

Chiefly among those were diabetes technologies and in vitro diagnostics (IVDs). We saw regulatory nods, product launches, funds raised and mergers fall apart.

Looking at those two spaces in particular, here are five diabetes and IVD stories that caught our attention in 2023:

5. Cytovale raises $84M Series C for sepsis diagnostic

In November, Cytovale announced that it raised $84 million in a Series C funding round to support its rapid sepsis diagnosis test. Cytovale earmarked funds to support the wider expansion of this testing technology.

The FDA cleared the IntelliSep test, which aids hospital emergency departments and health systems, in January. IntelliSep provides test results in under 10 minutes, offering actionable answers using standard b…

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Cytovale raises $84M Series C for sepsis diagnostic

The Cytovale System on which the IntelliSep diagnostic is run. [Image from Cytovale’s website]Cytovale announced today that it raised $84 million in a Series C funding round to support its rapid sepsis diagnosis test.

San Francisco-based Cytovale plans to use the funds to further expand the reach of its FDA-cleared IntelliSep sepsis test. The FDA cleared IntelliSep, which aids hospital emergency departments and health systems, in January.

IntelliSep provides test results in under 10 minutes, offering actionable answers using standard blood draws. The emergency department-focused tool helps clinicians recognize sepsis and make time-sensitive critical decisions. It can also integrate into existing emergency department workflows.

Using a unique approach, IntelliSep assesses the body’s immune response to an infection by interrogating immune cell morphology and mechanics. It “squeezes” white blood cells and characterizes their responses.<…

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FDA clears new sepsis diagnostic from Cytovale

The Cytovale System on which the IntelliSep diagnostic is run. [Image from Cytovale’s website]Cytovale announced today that it received FDA 510(k) clearance for its IntelliSep test for the early detection of sepsis.

San Francisco-based Cytovale designed IntelliSep to provide test results in under 10 minutes. The emergency department-focused tool helps clinicians recognize sepsis and make time-sensitive critical decisions. It provides actionable answers directly from a standard blood draw.

The diagnostic categorizes patients into three bands according to their probability of sepsis. Band 1 indicates a low probability of sepsis and the probability increases through Band 3. These results can help optimize clinical outcomes and improve hospital resource utilization, Cytovale said.

Cytovale completed its CV-SQuISH-ED study of the diagnostic in early 2022 and plans for publication soon. Data from previous studies demonstrate the test’s potential in de…

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