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 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.
4. FDA clears Tandem Diabetes Care’s Mobi durable automated insulin pump
The FDA in July granted clearance to the Tandem Mobi automated insulin delivery (AID) system. San Diego-based Tandem says Mobi, which is fully controllable from a mobile app, is the world’s smallest durable AID system.
Mobi features a 200-unit insulin cartridge and an on-pump button to provide an alternative to phone control for insulin boluses. It comes in at less than half the size of the existing Tandem pump system, the t:slim X2 pump.
According to the company, it can fit in a coin pocket, clip to clothing or go on the body with an adhesive sleeve.
3. Insulet makes progress on integrating Omnipod 5 with Abbott FreeStyle Libre 2
In June, Insulet provided updates on its Omnipod 5 automated insulin delivery system that included a major development on the integration front.
The company is moving toward its goal of giving Omnipod 5 users a choice over the sensor that accompanies their pump. Currently, Omnipod 5 works in conjunction with the Dexcom G6 continuous glucose monitor (CGM). Insulet said it expects to soon begin enrollment for a clinical study integrating Omnipod 5 with the Abbott FreeStyle Libre 2 sensor.
This would mark major progress for both companies, with Insulet also working to integrate the next-generation Dexcom G7. In the meantime, to kick off 2024, Abbott announced FreeStyle Libre 2 Plus integration with Tandem’s t:slim X2 pump.
2. Illumina
As 2023 neared its end, Illumina brought the curtain down over a long-running saga surrounding its attempted acquisition of Grail. Following legal battles over the $7.1 million acquisition, the company agreed to divest Grail, thanks to an appeals court’s decision to back the Federal Trade Commission.
In September 2020, Illumina announced an agreement to acquire Grail, a DNA sequencing and array-based tech developer. Grail itself was a startup that initially spun out from the company in 2016.
Illumina completed the acquisition in August 2021 but faced never-ending scrutiny in the two years that followed.
1. Medicare covers Dexcom G7 following much-anticipated launch
The aforementioned G7 launched nearly one year ago, following an ad campaign kicked off during the Super Bowl, and it launched with other significant news accompanying it.
Dexcom met the category requirements for therapeutic continuous glucose monitor (CGM) systems set forth by the Centers for Medicare and Medicaid Services (CMS). This made G7 accessible to all Medicare patients with diabetes who meet the eligibility criteria upon the company’s Feb. 17 launch.
CMS’ coverage expansion benefitted both Dexcom and Abbott as leaders in the CGM space after it later went into full effect in April 2023.
