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Abbott (ABT) Receives FDA Nod for FreeStyle Libre 3 System
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Abbott Laboratories’ (ABT - Free Report) next-generation FreeStyle Libre 3 system was recently approved by the FDA for diabetes patients aged four years and older. The FreeStyle Libre 3 system will be priced similarly to prior generations, allowing more diabetes patients to benefit from the next-generation technology.
The next-generation continuous glucose monitor (CGM) has been cleared for use with the FreeStyle Libre 3 iOS and Android mobile apps. This will allow users to view their glucose levels in real-time, track their glucose history and trends, and set up optional alarms and notifications to be alerted in times of important medical occurrences such as hypoglycemia.
The latest approval is likely to fortify Abbott's diabetes care business.
Few Words on the FreeStyle Libre 3
Abbott’s FreeStyle Libre 3 system has demonstrated the greatest accuracy, with an overall mean absolute relative difference (MARD) of 7.9%. It is the most accurate 14-day CGM with readings sent directly to a smartphone every minute. It is also the first CGM to achieve a sub-8% MARD, the standard way to measure continuous glucose accuracy. Per management, with the world's smallest and thinnest sensor and most accurate 14-day continuous glucose monitoring system, the FreeStyle Libre 3 system will enable people living with diabetes to manage their health minute-by-minute.
Image Source: Zacks Investment Research
The FreeStyle Libre 3 system is known to have the smallest and thinnest CGM sensor globally. With a one-piece applicator, the sensor does not present any complications when applying. It offers the strongest Bluetooth integration, compared to other CGMs, with a range of up to 33 feet. The FreeStyle Libre 3 sensor is expected to be available at participating pharmacies later in 2022.
More on the News
The FreeStyle Libre portfolio is the most extensively used GGM system in the United States and worldwide. The company has gained partial or full reimbursement for the FreeStyle Libre system in more than 40 countries, including Canada, France, Germany, Japan, the U.K. and the United States.
The mobile application for the FreeStyle Libre 3 integrates with the FreeStyle Libre digital ecosystem, including LibreView and LibreLinkUp. This facilitates caregivers and healthcare professionals to remotely monitor loved ones and patients.
Industry Prospects
Per a report published in Allied Market research, the global continuous glucose monitoring systems’ market size is expected to see a CAGR of 22% by 2027. Factors, including a surge in the geriatric population and the increasing prevalence of diabetes, are expected to fuel market growth.
Given the market potential, the FDA approval for FreeStyle Libre 3 system comes at an opportune time.
Other Notable Developments
In May 2022, Abbott gained FDA authorizations for the Alinity m STI Assay which detects and differentiates between four common sexually transmitted infections (STI) at the same time. This multiplex test runs on the Alinity m system, Abbott’s most advanced high-volume laboratory molecular instrument. It will help address the rising STI rates and enable healthcare providers to save time, increase efficiency and better serve patients.
In April 2022, the company noted the U.S. availability of its Amplatzer Steerable Delivery Sheath, which is used in conjunction with the Amplatzer Amulet Left Atrial Appendage (LAA) Occluder to treat atrial fibrillation (AFib) patients at risk of ischemic stroke. The Amplatzer Steerable Delivery Sheath is the newest addition to Abbott's comprehensive structural heart portfolio. It illustrates the company's commitment to innovating across heart conditions, including LAA occlusion (closure).
Share Price Performance
The stock has outperformed its industry over the past year. It has gained 11% against the industry’s 22.4% fall.
Zacks Rank and Key Picks
Currently, Abbott carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. (AMN - Free Report) , Medpace Holdings, Inc. (MEDP - Free Report) and Masimo Corporation (MASI - Free Report) .
AMN Healthcare has a long-term earnings growth rate of 1.1%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 15.6%, on average. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
AMN Healthcare has outperformed its industry in the past year. AMN has gained 4.4% against the industry’s 64.1% fall.
Medpace has a historical growth rate of 27.3%. Medpace’s earnings surpassed estimates in the trailing four quarters, the average surprise being 17.1%. It currently has a Zacks Rank #2 (Buy).
Medpace has outperformed its industry in the past year. MEDP has declined 15% compared with the industry’s 64.1% fall.
Masimo has a historical growth rate of 15.1%. Masimo’s earnings beat estimates in each of the trailing four quarters, the average surprise being 4.4%. The company currently carries a Zacks Rank #2.
Masimo has underperformed the industry in the past year. MASI has declined 34.1% compared with a 13.9% fall of the industry.
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Abbott (ABT) Receives FDA Nod for FreeStyle Libre 3 System
Abbott Laboratories’ (ABT - Free Report) next-generation FreeStyle Libre 3 system was recently approved by the FDA for diabetes patients aged four years and older. The FreeStyle Libre 3 system will be priced similarly to prior generations, allowing more diabetes patients to benefit from the next-generation technology.
The next-generation continuous glucose monitor (CGM) has been cleared for use with the FreeStyle Libre 3 iOS and Android mobile apps. This will allow users to view their glucose levels in real-time, track their glucose history and trends, and set up optional alarms and notifications to be alerted in times of important medical occurrences such as hypoglycemia.
The latest approval is likely to fortify Abbott's diabetes care business.
Few Words on the FreeStyle Libre 3
Abbott’s FreeStyle Libre 3 system has demonstrated the greatest accuracy, with an overall mean absolute relative difference (MARD) of 7.9%. It is the most accurate 14-day CGM with readings sent directly to a smartphone every minute. It is also the first CGM to achieve a sub-8% MARD, the standard way to measure continuous glucose accuracy. Per management, with the world's smallest and thinnest sensor and most accurate 14-day continuous glucose monitoring system, the FreeStyle Libre 3 system will enable people living with diabetes to manage their health minute-by-minute.
Image Source: Zacks Investment Research
The FreeStyle Libre 3 system is known to have the smallest and thinnest CGM sensor globally. With a one-piece applicator, the sensor does not present any complications when applying. It offers the strongest Bluetooth integration, compared to other CGMs, with a range of up to 33 feet. The FreeStyle Libre 3 sensor is expected to be available at participating pharmacies later in 2022.
More on the News
The FreeStyle Libre portfolio is the most extensively used GGM system in the United States and worldwide. The company has gained partial or full reimbursement for the FreeStyle Libre system in more than 40 countries, including Canada, France, Germany, Japan, the U.K. and the United States.
The mobile application for the FreeStyle Libre 3 integrates with the FreeStyle Libre digital ecosystem, including LibreView and LibreLinkUp. This facilitates caregivers and healthcare professionals to remotely monitor loved ones and patients.
Industry Prospects
Per a report published in Allied Market research, the global continuous glucose monitoring systems’ market size is expected to see a CAGR of 22% by 2027. Factors, including a surge in the geriatric population and the increasing prevalence of diabetes, are expected to fuel market growth.
Given the market potential, the FDA approval for FreeStyle Libre 3 system comes at an opportune time.
Other Notable Developments
In May 2022, Abbott gained FDA authorizations for the Alinity m STI Assay which detects and differentiates between four common sexually transmitted infections (STI) at the same time. This multiplex test runs on the Alinity m system, Abbott’s most advanced high-volume laboratory molecular instrument. It will help address the rising STI rates and enable healthcare providers to save time, increase efficiency and better serve patients.
In April 2022, the company noted the U.S. availability of its Amplatzer Steerable Delivery Sheath, which is used in conjunction with the Amplatzer Amulet Left Atrial Appendage (LAA) Occluder to treat atrial fibrillation (AFib) patients at risk of ischemic stroke. The Amplatzer Steerable Delivery Sheath is the newest addition to Abbott's comprehensive structural heart portfolio. It illustrates the company's commitment to innovating across heart conditions, including LAA occlusion (closure).
Share Price Performance
The stock has outperformed its industry over the past year. It has gained 11% against the industry’s 22.4% fall.
Zacks Rank and Key Picks
Currently, Abbott carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. (AMN - Free Report) , Medpace Holdings, Inc. (MEDP - Free Report) and Masimo Corporation (MASI - Free Report) .
AMN Healthcare has a long-term earnings growth rate of 1.1%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 15.6%, on average. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
AMN Healthcare has outperformed its industry in the past year. AMN has gained 4.4% against the industry’s 64.1% fall.
Medpace has a historical growth rate of 27.3%. Medpace’s earnings surpassed estimates in the trailing four quarters, the average surprise being 17.1%. It currently has a Zacks Rank #2 (Buy).
Medpace has outperformed its industry in the past year. MEDP has declined 15% compared with the industry’s 64.1% fall.
Masimo has a historical growth rate of 15.1%. Masimo’s earnings beat estimates in each of the trailing four quarters, the average surprise being 4.4%. The company currently carries a Zacks Rank #2.
Masimo has underperformed the industry in the past year. MASI has declined 34.1% compared with a 13.9% fall of the industry.