07.22.21
Rank: #3 (Last year: #3)
$22.59 Billion ($34.61 Billion)
Prior Fiscal: $19.95 Billion
Percentage Change: +13.2%
No. of Employees: 109,000 (total)
Global Headquarters: Abbott Park, Ill.
KEY EXECUTIVES:
Miles D. White, Executive Chairman of the Board
Robert B. Ford, President and CEO
Robert E. Funck, Jr., Exec. VP, Finance and CFO
Lisa D. Earnhardt, Exec. VP, Medical Devices
John F. Ginascol, Exec. VP, Core Diagnostics
Andrea F. Winter, Exec. VP, Rapid and Molecular Diagnostics
Greg Ahlberg, Sr. VP, Core Laboratory Diagnostics, Commercial Operations
Michael Dale, Sr. VP, Structural Heart
Louis H. Morrone, Sr. VP, Rapid Diagnostics
Michael J. Pedersen, Sr. VP, Electrophysiology and Heart Failure
Julie Tyler, Sr. VP, Vascular
Jared L. Watkin, Sr. VP, Diabetes Care
Randall Woodgrift, Sr. VP, Cardiac Rhythm Management
How does a business post double-digit growth during a pandemic?
Easy—be its premier diagnostic test supplier.
Abbott Labs began to supply mission-critical COVID-19 diagnostic tests as early as last March. The company was awarded emergency use authorization (EUA) for its first COVID-19 molecular PCR (polymerase chain reaction) test then, and immediately shipped 150,000 m 2000 RealTime systems to run the tests to existing customers. The company vowed to provide up to 1 million tests a week to support infection control efforts. An EUA in May to run the test on the Alinity m molecular laboratory instrument bolstered these efforts.
An EUA for the ID NOW molecular point-of-care COVID-19 test came about a week later. The test is able to deliver positive results in as little as five minutes, and negative results in 13. ID NOW’s small, lightweight, and portable design allowed a wide range of healthcare settings to offer rapid COVID-19 test results.
The ID NOW test came under scrutiny beginning in May, however. The FDA said in a statement that the test may return false negative results, citing preliminary data. The agency said at the time it had received 15 reports about the tests, and began reviewing the reports.
Responding to the reports, Abbott stated, “We're seeing studies being conducted to understand the role of ID NOW in ways that it was not designed to be used. In particular, the NYU study results are not consistent with other studies. While we've seen a few studies with sensitivity performance percentages in the 80s, we've also seen other studies with sensitivity at or above 90 percent, and one as high as 94 percent.”
Abbott released its own interim clinical study data about a week later, demonstrating ID NOW COVID-19 test performance was ≥94.7 percent in positive agreement (sensitivity) and ≥98.6 percent negative agreement (specificity) compared to two different lab-based PCR reference methods. The data also suggested ID NOW performed best in patients tested earlier post-symptom onset. Another set of interim clinical study results the firm published in October showed performance of 95 percent sensitivity and 97.9 percent specificity within seven days of symptom onset. According to Abbott, ID NOW became the most studied COVID-19 test available; the interim post-authorization study evaluated 1,003 people.
The third COVID-19 test—the SARS-CoV-2 IgG lab-based serology blood test to detect antibodies—arrived in mid-April. The test identifies if a person was previously infected, identifying the IgG protein that is produced in the late stages of infection and can remain for up to months and possibly years after recovery. It was made available on the Architect i 1000SR system, which can run 100-200 tests per hour. The company shipped a total of 4 million tests in April, and ramped up to nearly 30 million tests in May due to an EUA for the IgG test on the Alinity i system as well. The company also received a government contract to supply millions of these tests to National Health Service labs across the U.K. in May, beginning with 800,000 antibody tests shipped. The test received EU approval in December.
Another lab-based serology test—AdviseDx SARS-CoV-2 IgM—gained EUA in October to run on the Architect and Alinity platforms. The IgM antibody helps determine recent infection because those antibodies become undetectable within weeks or months following infection.
The most welcome diagnostic innovation via EUA arrived last August—the BinaxNOW COVID-19 Ag card rapid antigen test. The credit card-sized nasal swab test costs only $5 and can spot active COVID-19 infection in 15 minutes.
"Results can be read directly from the testing card, a similar design to some pregnancy tests," the FDA said in a statement. "This simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer."
ANALYST INSIGHTS: Abbott has had a great run due to their COVID capabilities in their Diagnostics business. At the same time, their Diabetes products continue to hum along with positive growth. While their stock may have a temporary softness due to the high expectations during COVID, expect Abbott to continue to outperform in the long run.
Abbott simultaneously launched the complementary NAVICA app to display a temporary digital health pass renewed with each new diagnostic test. Clinical study data on BinaxNOW demonstrated 97.1 percent sensitivity and 98.5 percent specificity within seven days of symptom onset. Abbott pledged to ship 50 million tests a month by October.
Two days later, the Trump Administration struck a $750 million deal with Abbott for 150 million of the rapid tests to increase rapid testing availability. The government began distributing the tests a month later.
“This is a major development that will help our country to remain open, get Americans back to work, and kids back to school,” then-White House Strategic Communications Director Alyssa Farah told the press. “The Trump administration is proud to partner with Abbott Labs to make this purchase possible to help the American people."
The first shipments of 6.5 million tests rolled out that week, each state receiving their share based on population.
In December, BinaxNow grabbed an EUA for virtually guided home use. Abbott partnered with digital health firm eMed to deliver an expected 30 million home tests in this year’s first quarter, with 90 million more after the second quarter expected. eMed’s service determines eligibility, guides self-collection, generates public health reporting requirements, and generates results via the NAVICA app in about 20 minutes for $25 a pop.
Abbott’s diagnostic prowess won the company an impressive 13.2 revenue boost from the prior year. The firm’s medical device and diagnostics business pocketed nearly $22.95 billion. The chief drivers were the molecular diagnostic and rapid diagnostic businesses, which skyrocketed 225 percent to $1.4 billion and 113 percent to $4.3 billion, respectively. The core laboratory business fell 4 percent to $4.5 billion, and the point of care segment slipped 8 percent to $516 million.
Save for the two diagnostics franchises and one medical device business (stay tuned) all Abbott medtech categories reported losses due to the global pandemic slowing production and stifling elective procedures. The historically profitable rhythm management business fell 3 percent to $2.1 billion.
The Gallant ICD and CRT-D devices obtained CE marks last February. The devices pair with Abbott's secure myMerlinPulse mobile app to help streamline communication and increase engagement between doctors and patients. The CRT-D system includes Abbott's MultiPoint Pacing and SyncAV features to help more patients respond to CRT therapy. The ICD device features Abbott's TailoredTherapy suite to help physicians more intuitively program devices. The Gallant devices received FDA approval last July.
Structural heart revenue slowed 11 percent to reach $1.2 billion in revenue last year.
At the end of last January, Abbott earned EU approval for the Tendyne transcatheter mitral valve implantation (TAVI) system. For patients at high risk for open-heart surgery or in situations when the mitral valve is too damaged for a successful repair with the firm’s MitraClip device, Tendyne offers a minimally invasive treatment option when the leaky valve must be replaced. The self-expanding valve is delivered through a small incision in the chest and up through the heart, where it’s implanted in a beating heart, replacing the native mitral valve.
The FlexNav delivery system to improve control and delivery of the firm’s Portico TAVI system garnered a CE mark last March. Physicians implanting Portico gained the benefit of improved delivery, flexibility, and navigation during implantation, even in complex cardiac anatomies.
The TriClip transcatheter tricuspid valve repair system won CE mark last April. According to Abbott, it is the first minimally invasive, clip-based tricuspid valve repair device in the world. It’s delivered through the femoral vein and works by clipping together a portion of the leaflets of the tricuspid valve to reduce backflow of blood, allowing the heart to pump blood more efficiently. TriClip leverages the same clip-based technology as MitraClip with a differentiated delivery system designed for delivery to the tricuspid valve.
In July the firm resolved its patent disputes with Edward Lifesciences related to transcatheter mitral and tricuspid repair products. All pending cases and appeals were dismissed and the companies agreed not to litigate patent disputes with each other in those fields for 10 years. The injunctions in place against the sale of Edwards’ transcatheter mitral and tricuspid repair system were lifted. Abbott received a one-time payment and will receive ongoing payments based on Edwards’ Pascal sales through 2025.
The fourth-gen MitraClip TMVR system (MitraClip G4) acquired a CE mark in September. Enhancements to the delivery system offer advanced steering during implant, four clip sizes with two wider clips, and independently controlled grippers to grasp one or both mitral valve leaflets at a time during the procedure.
Vascular product sales plummeted 18 percent to $2.3 billion, the drastic drop in part due to COVID-19 and from lower Chinese sales in 2020’s fourth quarter resulting from a new national tender program.
The firm launched a virtual reality-based training program for cardiologists in December. It incorporates virtual with traditional training techniques to increase experience and expertise in using Abbott’s OCT (optical coherence tomography) imaging and improve outcomes in patients needing a stent to open clogged arteries. The new OCT virtual reality-based training programs, powered by Oculus Go, aim to dramatically enhance decision-making for physicians utilizing OCT instead of angiography.
Electrophysiology and heart failure proceeds fell 8 and 4 percent respectively, to $1.6 billion and $740 million.
At the beginning of last year the company earned FDA approval for an alternative surgical technique for the HeartMate 3 heart pump that allows heart failure patients to avoid open heart surgery. The lateral thoracotomy technique creates an incision between the ribs to access the heart rather than typical open heart surgery, and can result in less bleeding and shorter recovery times. HeartMate 3 was approved for pediatric patients battling advanced refractory left ventricular heart failure in December.
The EnSite X EP system nabbed a CE mark and approval in Australia in November. The system creates a 3D model of cardiac anatomy in real-time so areas of the heart needing ablation treatment are clearly seen. Traditional impedance monitoring or electromagnetic technology can be used to precisely locate sensor-enabled catheters during treatment.
Neuromodulation was hit second-hardest, reporting a 16 percent loss with $702 million in sales.
Last January saw expanded indication for the Infinity deep brain stimulation (DBS) system that extended the device’s reach to the brain’s internal globus pallidus (GPi). The GPi is crucial to motor function, and targeting it with DBS can improve Parkinson’s symptoms not controlled by medication. With this approval, the Infinity DBS is approved for all major targets used to treat movement disorders, Parkinson's, and essential tremor: the subthalamic nucleus, ventral intermediate nucleus, and GPi.
Abbott gained FDA approval for a Patient Controller app on iOS devices in July. It was integrated into Abbott's broader NeuroSphere Digital Care connected care management platform, which was released in May. It is compatible with the Infinity DBS System, Proclaim XR SCS System, and Proclaim DRG Neurostimulation System, allowing physicians to more easily treat individual patient needs.
The IonicRF generator launched in the U.S. in November. The minimally invasive radiofrequency ablation device uses heat to target specific nerves and block pain signals for up to a year. It was the first Abbott-developed radiofrequency ablation device and is approved in Europe as well.
The lone medical device business to profit last year was Abbott’s powerhouse diabetes care portfolio. The franchise pocketed $3.3 billion last year, rising a remarkable 29 percent amid the health crisis due to continued strong sales of the FreeStyle Libre continuous glucose monitoring (CGM) system. FreeStyle Libre sales totaled $2.6 billion, a 42.6 percent rise over the prior year.
Last February Abbott and Insulet Corporation began a partnership to integrate glucose sensing and automated delivery technologies. The collaboration combined the FreeStyle Libre CGM with Insulet’s Omnipod Horizon automated, tubeless insulin delivery system. Glucose data from the sensor will be sent to the Omnipod, which is embedded with an algorithm to automatically adjust insulin delivery without an additional device, connection, or tubing. The system will always remain in automated insulin delivery mode and can be controlled through a smartphone app.
In April the company earned FDA authorization to use the FreeStyle Libre 14 day system in a hospital setting so frontline healthcare workers could remotely monitor diabetes patients receiving inpatient care. The firm also donated 25,000 FreeStyle Libre 14 day sensors in partnership with the American Diabetes Association, Insulin for Life USA, and Diabetes Disaster Response Coalition. Health Canada authorization for this was obtained at the end of April.
In June Abbott finalized the agreement began in 2019 with Tandem Diabetes Care to develop and commercialize solutions combining FreeStyle Libre and Tandem’s t:slim X2 insulin pump. The firms will work to digitally connect their technologies for future automated insulin delivery systems, which will provide options to tailor and simplify diabetes management.
The Libre Sense glucose sport biosensor was introduced in Europe via CE mark in September. The consumer over-the-counter product provides glucose monitoring via a mobile app to athletes aged 16+ performing cycling, running, and swimming, to understand the efficacy of their nutrition choices on training and competition. Tracking and understanding glucose levels helps athletes fuel appropriately through nutrition to avoid fatigue from low glucose and know when to replenish during training and competition.
The FreeStyle Libre 3 CGM system earned CE mark certification in September as well. It features a 14-day wear time and a smaller and thinner sensor—total volume was 70 percent reduced, according to Abbott. The sensor is applied via a one-piece applicator worn on the back of the upper arm and does not need a fingerstick. An accompanying mobile app enables users to capture and view real-time glucose levels, glucose history, and trend arrows.
$22.59 Billion ($34.61 Billion)
Prior Fiscal: $19.95 Billion
Percentage Change: +13.2%
No. of Employees: 109,000 (total)
Global Headquarters: Abbott Park, Ill.
KEY EXECUTIVES:
Miles D. White, Executive Chairman of the Board
Robert B. Ford, President and CEO
Robert E. Funck, Jr., Exec. VP, Finance and CFO
Lisa D. Earnhardt, Exec. VP, Medical Devices
John F. Ginascol, Exec. VP, Core Diagnostics
Andrea F. Winter, Exec. VP, Rapid and Molecular Diagnostics
Greg Ahlberg, Sr. VP, Core Laboratory Diagnostics, Commercial Operations
Michael Dale, Sr. VP, Structural Heart
Louis H. Morrone, Sr. VP, Rapid Diagnostics
Michael J. Pedersen, Sr. VP, Electrophysiology and Heart Failure
Julie Tyler, Sr. VP, Vascular
Jared L. Watkin, Sr. VP, Diabetes Care
Randall Woodgrift, Sr. VP, Cardiac Rhythm Management
How does a business post double-digit growth during a pandemic?
Easy—be its premier diagnostic test supplier.
Abbott Labs began to supply mission-critical COVID-19 diagnostic tests as early as last March. The company was awarded emergency use authorization (EUA) for its first COVID-19 molecular PCR (polymerase chain reaction) test then, and immediately shipped 150,000 m 2000 RealTime systems to run the tests to existing customers. The company vowed to provide up to 1 million tests a week to support infection control efforts. An EUA in May to run the test on the Alinity m molecular laboratory instrument bolstered these efforts.
An EUA for the ID NOW molecular point-of-care COVID-19 test came about a week later. The test is able to deliver positive results in as little as five minutes, and negative results in 13. ID NOW’s small, lightweight, and portable design allowed a wide range of healthcare settings to offer rapid COVID-19 test results.
The ID NOW test came under scrutiny beginning in May, however. The FDA said in a statement that the test may return false negative results, citing preliminary data. The agency said at the time it had received 15 reports about the tests, and began reviewing the reports.
Responding to the reports, Abbott stated, “We're seeing studies being conducted to understand the role of ID NOW in ways that it was not designed to be used. In particular, the NYU study results are not consistent with other studies. While we've seen a few studies with sensitivity performance percentages in the 80s, we've also seen other studies with sensitivity at or above 90 percent, and one as high as 94 percent.”
Abbott released its own interim clinical study data about a week later, demonstrating ID NOW COVID-19 test performance was ≥94.7 percent in positive agreement (sensitivity) and ≥98.6 percent negative agreement (specificity) compared to two different lab-based PCR reference methods. The data also suggested ID NOW performed best in patients tested earlier post-symptom onset. Another set of interim clinical study results the firm published in October showed performance of 95 percent sensitivity and 97.9 percent specificity within seven days of symptom onset. According to Abbott, ID NOW became the most studied COVID-19 test available; the interim post-authorization study evaluated 1,003 people.
The third COVID-19 test—the SARS-CoV-2 IgG lab-based serology blood test to detect antibodies—arrived in mid-April. The test identifies if a person was previously infected, identifying the IgG protein that is produced in the late stages of infection and can remain for up to months and possibly years after recovery. It was made available on the Architect i 1000SR system, which can run 100-200 tests per hour. The company shipped a total of 4 million tests in April, and ramped up to nearly 30 million tests in May due to an EUA for the IgG test on the Alinity i system as well. The company also received a government contract to supply millions of these tests to National Health Service labs across the U.K. in May, beginning with 800,000 antibody tests shipped. The test received EU approval in December.
Another lab-based serology test—AdviseDx SARS-CoV-2 IgM—gained EUA in October to run on the Architect and Alinity platforms. The IgM antibody helps determine recent infection because those antibodies become undetectable within weeks or months following infection.
The most welcome diagnostic innovation via EUA arrived last August—the BinaxNOW COVID-19 Ag card rapid antigen test. The credit card-sized nasal swab test costs only $5 and can spot active COVID-19 infection in 15 minutes.
"Results can be read directly from the testing card, a similar design to some pregnancy tests," the FDA said in a statement. "This simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer."
ANALYST INSIGHTS: Abbott has had a great run due to their COVID capabilities in their Diagnostics business. At the same time, their Diabetes products continue to hum along with positive growth. While their stock may have a temporary softness due to the high expectations during COVID, expect Abbott to continue to outperform in the long run.
—Dave Sheppard, Co-Founder and Managing Director, MedWorld Advisors
Abbott simultaneously launched the complementary NAVICA app to display a temporary digital health pass renewed with each new diagnostic test. Clinical study data on BinaxNOW demonstrated 97.1 percent sensitivity and 98.5 percent specificity within seven days of symptom onset. Abbott pledged to ship 50 million tests a month by October.
Two days later, the Trump Administration struck a $750 million deal with Abbott for 150 million of the rapid tests to increase rapid testing availability. The government began distributing the tests a month later.
“This is a major development that will help our country to remain open, get Americans back to work, and kids back to school,” then-White House Strategic Communications Director Alyssa Farah told the press. “The Trump administration is proud to partner with Abbott Labs to make this purchase possible to help the American people."
The first shipments of 6.5 million tests rolled out that week, each state receiving their share based on population.
In December, BinaxNow grabbed an EUA for virtually guided home use. Abbott partnered with digital health firm eMed to deliver an expected 30 million home tests in this year’s first quarter, with 90 million more after the second quarter expected. eMed’s service determines eligibility, guides self-collection, generates public health reporting requirements, and generates results via the NAVICA app in about 20 minutes for $25 a pop.
Abbott’s diagnostic prowess won the company an impressive 13.2 revenue boost from the prior year. The firm’s medical device and diagnostics business pocketed nearly $22.95 billion. The chief drivers were the molecular diagnostic and rapid diagnostic businesses, which skyrocketed 225 percent to $1.4 billion and 113 percent to $4.3 billion, respectively. The core laboratory business fell 4 percent to $4.5 billion, and the point of care segment slipped 8 percent to $516 million.
Save for the two diagnostics franchises and one medical device business (stay tuned) all Abbott medtech categories reported losses due to the global pandemic slowing production and stifling elective procedures. The historically profitable rhythm management business fell 3 percent to $2.1 billion.
The Gallant ICD and CRT-D devices obtained CE marks last February. The devices pair with Abbott's secure myMerlinPulse mobile app to help streamline communication and increase engagement between doctors and patients. The CRT-D system includes Abbott's MultiPoint Pacing and SyncAV features to help more patients respond to CRT therapy. The ICD device features Abbott's TailoredTherapy suite to help physicians more intuitively program devices. The Gallant devices received FDA approval last July.
Structural heart revenue slowed 11 percent to reach $1.2 billion in revenue last year.
At the end of last January, Abbott earned EU approval for the Tendyne transcatheter mitral valve implantation (TAVI) system. For patients at high risk for open-heart surgery or in situations when the mitral valve is too damaged for a successful repair with the firm’s MitraClip device, Tendyne offers a minimally invasive treatment option when the leaky valve must be replaced. The self-expanding valve is delivered through a small incision in the chest and up through the heart, where it’s implanted in a beating heart, replacing the native mitral valve.
The FlexNav delivery system to improve control and delivery of the firm’s Portico TAVI system garnered a CE mark last March. Physicians implanting Portico gained the benefit of improved delivery, flexibility, and navigation during implantation, even in complex cardiac anatomies.
The TriClip transcatheter tricuspid valve repair system won CE mark last April. According to Abbott, it is the first minimally invasive, clip-based tricuspid valve repair device in the world. It’s delivered through the femoral vein and works by clipping together a portion of the leaflets of the tricuspid valve to reduce backflow of blood, allowing the heart to pump blood more efficiently. TriClip leverages the same clip-based technology as MitraClip with a differentiated delivery system designed for delivery to the tricuspid valve.
In July the firm resolved its patent disputes with Edward Lifesciences related to transcatheter mitral and tricuspid repair products. All pending cases and appeals were dismissed and the companies agreed not to litigate patent disputes with each other in those fields for 10 years. The injunctions in place against the sale of Edwards’ transcatheter mitral and tricuspid repair system were lifted. Abbott received a one-time payment and will receive ongoing payments based on Edwards’ Pascal sales through 2025.
The fourth-gen MitraClip TMVR system (MitraClip G4) acquired a CE mark in September. Enhancements to the delivery system offer advanced steering during implant, four clip sizes with two wider clips, and independently controlled grippers to grasp one or both mitral valve leaflets at a time during the procedure.
Vascular product sales plummeted 18 percent to $2.3 billion, the drastic drop in part due to COVID-19 and from lower Chinese sales in 2020’s fourth quarter resulting from a new national tender program.
The firm launched a virtual reality-based training program for cardiologists in December. It incorporates virtual with traditional training techniques to increase experience and expertise in using Abbott’s OCT (optical coherence tomography) imaging and improve outcomes in patients needing a stent to open clogged arteries. The new OCT virtual reality-based training programs, powered by Oculus Go, aim to dramatically enhance decision-making for physicians utilizing OCT instead of angiography.
Electrophysiology and heart failure proceeds fell 8 and 4 percent respectively, to $1.6 billion and $740 million.
At the beginning of last year the company earned FDA approval for an alternative surgical technique for the HeartMate 3 heart pump that allows heart failure patients to avoid open heart surgery. The lateral thoracotomy technique creates an incision between the ribs to access the heart rather than typical open heart surgery, and can result in less bleeding and shorter recovery times. HeartMate 3 was approved for pediatric patients battling advanced refractory left ventricular heart failure in December.
The EnSite X EP system nabbed a CE mark and approval in Australia in November. The system creates a 3D model of cardiac anatomy in real-time so areas of the heart needing ablation treatment are clearly seen. Traditional impedance monitoring or electromagnetic technology can be used to precisely locate sensor-enabled catheters during treatment.
Neuromodulation was hit second-hardest, reporting a 16 percent loss with $702 million in sales.
Last January saw expanded indication for the Infinity deep brain stimulation (DBS) system that extended the device’s reach to the brain’s internal globus pallidus (GPi). The GPi is crucial to motor function, and targeting it with DBS can improve Parkinson’s symptoms not controlled by medication. With this approval, the Infinity DBS is approved for all major targets used to treat movement disorders, Parkinson's, and essential tremor: the subthalamic nucleus, ventral intermediate nucleus, and GPi.
Abbott gained FDA approval for a Patient Controller app on iOS devices in July. It was integrated into Abbott's broader NeuroSphere Digital Care connected care management platform, which was released in May. It is compatible with the Infinity DBS System, Proclaim XR SCS System, and Proclaim DRG Neurostimulation System, allowing physicians to more easily treat individual patient needs.
The IonicRF generator launched in the U.S. in November. The minimally invasive radiofrequency ablation device uses heat to target specific nerves and block pain signals for up to a year. It was the first Abbott-developed radiofrequency ablation device and is approved in Europe as well.
The lone medical device business to profit last year was Abbott’s powerhouse diabetes care portfolio. The franchise pocketed $3.3 billion last year, rising a remarkable 29 percent amid the health crisis due to continued strong sales of the FreeStyle Libre continuous glucose monitoring (CGM) system. FreeStyle Libre sales totaled $2.6 billion, a 42.6 percent rise over the prior year.
Last February Abbott and Insulet Corporation began a partnership to integrate glucose sensing and automated delivery technologies. The collaboration combined the FreeStyle Libre CGM with Insulet’s Omnipod Horizon automated, tubeless insulin delivery system. Glucose data from the sensor will be sent to the Omnipod, which is embedded with an algorithm to automatically adjust insulin delivery without an additional device, connection, or tubing. The system will always remain in automated insulin delivery mode and can be controlled through a smartphone app.
In April the company earned FDA authorization to use the FreeStyle Libre 14 day system in a hospital setting so frontline healthcare workers could remotely monitor diabetes patients receiving inpatient care. The firm also donated 25,000 FreeStyle Libre 14 day sensors in partnership with the American Diabetes Association, Insulin for Life USA, and Diabetes Disaster Response Coalition. Health Canada authorization for this was obtained at the end of April.
In June Abbott finalized the agreement began in 2019 with Tandem Diabetes Care to develop and commercialize solutions combining FreeStyle Libre and Tandem’s t:slim X2 insulin pump. The firms will work to digitally connect their technologies for future automated insulin delivery systems, which will provide options to tailor and simplify diabetes management.
The Libre Sense glucose sport biosensor was introduced in Europe via CE mark in September. The consumer over-the-counter product provides glucose monitoring via a mobile app to athletes aged 16+ performing cycling, running, and swimming, to understand the efficacy of their nutrition choices on training and competition. Tracking and understanding glucose levels helps athletes fuel appropriately through nutrition to avoid fatigue from low glucose and know when to replenish during training and competition.
The FreeStyle Libre 3 CGM system earned CE mark certification in September as well. It features a 14-day wear time and a smaller and thinner sensor—total volume was 70 percent reduced, according to Abbott. The sensor is applied via a one-piece applicator worn on the back of the upper arm and does not need a fingerstick. An accompanying mobile app enables users to capture and view real-time glucose levels, glucose history, and trend arrows.