Throughout 2023, the medical technology industry produced an impressive year of innovation, with news coming from a variety of sectors.
Among them were mainly diabetes technology and in vitro diagnostics (IVD). We’ve seen regulatory consents, product launches, financings, and mergers fail.
With a particular focus on these two areas, here are five diabetes and IVD stories that caught our attention in 2023.
5. Cytovale raises $84 million in Series C for sepsis diagnostics
In November, Cytovale announced it had raised $84 million in a Series C funding round to support its rapid sepsis diagnostic test. Cytovale has allocated funding to support widespread expansion of this testing technology.
In January, the FDA cleared the IntelliSep test to assist hospital emergency departments and health systems. IntelliSep provides test results within 10 minutes and uses a standard blood draw to provide actionable answers. Emergency department-focused tools help clinicians recognize sepsis and make critical, time-sensitive decisions. It can also be integrated into existing emergency department workflows.
Read the full text here.
4. FDA approves Tandem Diabetes Care’s Mobi durable automatic insulin pump
In July, the FDA granted approval for the Tandem Mobi automated insulin delivery (AID) system. San Diego-based Tandem says his Mobi, which is fully controllable from a mobile app, is the world’s smallest durable AID system.
The Mobi features a 200-unit insulin cartridge and an on-pump button, providing an alternative to phone control for insulin bolus administration. It is less than half the size of the existing tandem pump system, the t:slim X2 pump.
The company says it can fit in a coin pocket, clip onto clothing or attach to the body with an adhesive sleeve.
Read the full text here.
3. Insulet is integrating Omnipod 5 and Abbott FreeStyle Libre 2
In June, Insulet provided updates to its Omnipod 5 automated insulin dosing system, including key developments on the integration front.
The company is moving toward the goal of allowing Omnipod 5 users to choose the sensor that comes with their pump. Currently, the Omnipod 5 works in conjunction with his Dexcom G6 continuous glucose monitor (CGM). Insulet said it will soon begin enrollment in a clinical study integrating the Omnipod 5 and Abbott FreeStyle Libre 2 sensors.
This is a huge step forward for both companies, and Insulet is also working on integrating the next generation Dexcom G7. Meanwhile, to start 2024, Abbott announced the integration of his FreeStyle Libre 2 Plus with Tandem’s t:slim X2 pump.
Read the full text here.
2. Illumina
As 2023 draws to a close, Illumina brings to a close the long-running saga surrounding its attempted acquisition of Grail. After a $7.1 million legal battle over the acquisition, the company agreed to sell Grail, thanks to an appeals court decision in favor of the Federal Trade Commission.
In September 2020, Illumina announced an agreement to acquire Grail, a DNA sequencing and array-based technology developer. Grail itself was a startup spun out of the company in 2016.
Illumina completed the acquisition in August 2021, but the next two years were subject to endless scrutiny.
Read the full text here.
1. Medicare covers Dexcom G7 with long-awaited launch
The aforementioned G7 launched nearly a year ago with an ad campaign that launched during the Super Bowl, along with other important news announcements.
Dexcom has met the therapeutic continuous glucose monitor (CGM) system category requirements set by the Centers for Medicare and Medicaid Services (CMS). This made G7 available to all diabetic Medicare patients who met the eligibility criteria at the time of the company’s incorporation on February 17th.
The CMS coverage expansion, which then became fully effective in April 2023, benefited both Dexcom and Abbott as leaders in the CGM space.
Read the full text here.
