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Abbott (ABT) to Pair CGM Sensors & AID System on FDA Clearance

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Abbott Laboratories (ABT - Free Report) recently announced that its modified continuous glucose monitoring (CGM) system sensors, FreeStyle Libre 2 and FreeStyle Libre 3, have received FDA clearance for integration with automated insulin delivery (AID) systems.

The company’s AID systems help people in their daily diabetes monitoring by automatically adjusting and administering the insulin delivered by an insulin pump based on real-time glucose data from their FreeStyle Libre 2 or FreeStyle Libre 3 sensors.

The latest development, while advancing Abbott’s Diabetes Care business line, upholds its target to effortlessly serve diabetes patients by providing them with an affordable option to pair with their insulin pumps.

About FreeStyle Libre System

The FreeStyle Libre portfolio of Abbott is a revolutionary system, which eliminates the hurdles of traditional glucose monitoring by providing affordable and easily accessible breakthrough technology.

Having served nearly 4.5 million people across more than 60 countries, the modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors are expected to be available in the United States towards the end of the year.

The modified sensors will eventually replace the existing sensors of the Freestyle Libre portfolio which are currently available in the U.S. markets.


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Additionally, the modified sensors were also cleared for use by children as young as two years old and for wear time of up to 15 days. Presently, the FreeStyle Libre 2 and FreeStyle Libre 3 sensors, which are available in the domestic markets, are approved for four years and older children and have a wear time of up to 14 days.

Further, the existing FreeStyle Libre 2 and FreeStyle Libre 3 sensors and the modified sensors are both allowed clearance to be used by pregnant women with Type 1, Type 2 and gestational diabetes.

To speed up the process of integrating insulin pumps with the modified sensors throughout the United States and other countries, Abbott has started partnering with leading manufacturers, Insulet and Tandem. The company’s FreeStyle Libre 3 sensor is already authorized to work with the mylife Loop solution from Ypsomed and CamDiab in Germany. Additional launches in the UK, Switzerland and the Netherlands are planned for the first half of this year.

Industry Prospects

Per a Research report, the global diabetes devices market size was valued at $26.7 billion in 2021 and is expected to witness a compound annual growth rate (CAGR) of 8.2% by 2030.

The increasing adoption of insulin delivery devices and rising prevalence of diabetes are driving market growth. Leading manufacturers are focusing on technological innovations and the development of advanced products to gain a substantial share of the market.

Recent Developments

Earlier this month, Abbott received FDA clearance for the first-ever commercially available laboratory traumatic brain injury blood test, making it widely available to hospitals in the United States. The test currently runs on Abbott's Alinity i-STAT laboratory instrument and will provide clinicians with an objective way to quickly assess individuals with mild concussions.

Abbott also presented late-breaking data from the landmark COAPT trial for MitraClip – the company’s leading therapy to treat leaky valves in people with mitral regurgitation (MR). The five-year results show that MitraClip is safe and effective and can cut the rate of hospitalizations while improving survival for heart failure patients with severe secondary or functional MR.

Price Performance

In the past six months, ABT has mostly underperformed its industry. Shares of the company have declined 8.3% compared with the industry’s fall of 5.8%.

Zacks Rank and Key Picks

Abbott Laboratories carries a Zacks Rank #3 (Hold).

Some better ranked stocks in the overall healthcare sector are Haemonetics Corporation (HAE - Free Report) , TerrAscend Corp. (TRSSF - Free Report) and Akerna Corp. (KERN - Free Report) . Haemonetics and TerrAscend sport a Zacks Rank #1 (Strong Buy), while Akerna carries a Zack Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here

Haemonetics’ stock has risen 45% in the past year. Earnings estimates for Haemonetics have increased from $2.91 per share to $2.94 for 2023, and from $3.28 per share to $3.29 for 2024 in the past 30 days.

HAE’s earnings beat estimates in all the last four quarters, delivering an average surprise of 10.98%. In the last reported quarter, it reported an earnings surprise of 7.59%.

Estimates for TerrAscend in 2023 have decreased from a loss of 10 cents per share to a loss of 9 cents per share in the past 30 days. Shares of TerrAscend have declined 66.9% in the past year.

TerrAscend’s earnings beat estimates in one of the last three quarters and missed the mark in the other two, the average negative surprise being 136.11%. In the last reported quarter, TRSSF delivered an earnings surprise of 216.67%.

Akerna’s stock has declined 95.7% in the past year. Its estimates for 2023 have remained constant at a loss of $1.91 per share over the past 30 days.

Akerna missed earnings estimates in all the last four quarters, delivering a negative earnings surprise of 15.49%, on average. In the last reported quarter, KERN delivered a negative earnings surprise of 13.33%.

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