Abbott Reports First-Quarter 2021 Results

Abbott (NYSE: ABT) today announced financial results for the first quarter ended March 31, 2021 .

  • First-quarter sales of $10.5 billion increased 35.3 percent on a reported basis and 32.9 percent on an organic basis, which excludes the impact of foreign exchange.
  • First-quarter GAAP diluted EPS was $1.00 and adjusted diluted EPS, which excludes specified items, was $1.32 , reflecting 103.1 percent growth versus the prior year. 1
  • Abbott projects full-year 2021 diluted EPS from continuing operations on a GAAP basis of at least $3.74 . Projected full-year adjusted diluted EPS from continuing operations of at least $5.00 remains unchanged and reflects growth of more than 35 percent versus the prior year. 2
  • Global COVID-19 testing-related sales were $2.2 billion in the first quarter, led by combined sales of $1.8 billion from Abbott's BinaxNOW , Panbio and ID NOW rapid testing platforms.
  • First-quarter sales increased 7.6 percent on a reported basis and 5.7 percent on an organic basis, excluding COVID-19 testing-related sales.
  • In January, the U.S. Centers for Medicare & Medicaid Services expanded reimbursement coverage eligibility for Abbott's revolutionary MitraClip device, which significantly increases the number of people who can benefit from this market-leading, minimally invasive heart device.
  • In March, Abbott announced the U.S. launch of NeuroSphere Virtual Clinic, a first-of-its-kind technology that allows patients to communicate with physicians, ensure proper settings and functionality, and receive new treatment settings remotely as needed.
  • In April, Abbott announced U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) of its BinaxNOW COVID-19 Ag Self Test for individuals with or without symptoms and without the need of a prescription.

"We're off to a very strong start to the year, with all four of our major businesses achieving strong growth," said Robert B. Ford , president and chief executive officer, Abbott. "We're particularly pleased with the growing momentum of several recently launched products and continue to forecast more than 35 percent EPS growth for the year."

FIRST-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business. Organic sales growth excludes the impact of foreign exchange.

Following are sales by business segment and commentary for the first quarter 2021:

Total Company
($ in millions)









% Change vs. 1Q20



Sales 1Q21


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total *


3,838


6,618


10,456


34.4


35.9


35.3


34.4


32.0


32.9

Nutrition


836


1,200


2,036


3.0


9.8


6.9


3.0


9.0


6.4

Diagnostics


1,641


2,373


4,014


104.4


131.9


119.8


104.4


122.9


114.8

Established Pharmaceuticals


--


1,070


1,070


n/a


2.5


2.5


n/a


6.2


6.2

Medical Devices


1,351


1,969


3,320


9.6


15.6


13.1


9.6


8.2


8.8


* Total Q1 2021 Abbott sales from continuing operations include Other Sales of approximately $16 million.


n/a = Not Applicable.


Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate,
by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year
foreign exchange rates.

First-quarter 2021 worldwide sales of $10.5 billion increased 35.3 percent on a reported basis and 32.9 percent on an organic basis.

Nutrition
($ in millions)









% Change vs. 1Q20



Sales 1Q21


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


836


1,200


2,036


3.0


9.8


6.9


3.0


9.0


6.4

Pediatric


508


558


1,066


(1.8)


(2.3)


(2.1)


(1.8)


(3.1)


(2.5)

Adult


328


642


970


11.4


23.1


18.9


11.4


22.1


18.3

Worldwide Nutrition sales increased 6.9 percent on a reported basis and 6.4 percent on an organic basis in the first quarter. Strong performance of Ensure ® , Abbott's market-leading complete and balanced nutrition brand, and Glucerna ® , Abbott's market-leading diabetes nutrition brand, led to global Adult Nutrition sales growth of 18.9 percent on a reported basis and 18.3 percent on an organic basis. In Pediatric Nutrition, sales growth was negatively impacted by a difficult comparison versus the first quarter of 2020 when consumers increased purchases in advance of stay-at-home directives as a result of COVID-19.

Diagnostics
($ in millions)









% Change vs. 1Q20



Sales 1Q21


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


1,641


2,373


4,014


104.4


131.9


119.8


104.4


122.9


114.8

Core Laboratory


271


911


1,182


1.9


26.1


19.6


1.9


21.3


16.1

Molecular


175


272


447


168.7


267.0


220.9


168.7


250.2


212.0

Point of Care


92


37


129


(11.4)


7.8


(6.6)


(11.4)


3.8


(7.6)

Rapid Diagnostics


1,103


1,153


2,256


199.7


500.6


302.8


199.7


477.7


295.0

Worldwide Diagnostics sales increased 119.8 percent on a reported basis in the first quarter and increased 114.8 percent on an organic basis. Strong growth in the quarter was driven by demand for Abbott's portfolio of COVID-19 diagnostics tests across its rapid and lab-based platforms. Global COVID-19 testing-related sales were $2.2 billion in the first quarter, led by combined sales of $1.8 billion from Abbott's BinaxNOW, Panbio and ID NOW rapid testing platforms.

Excluding COVID-19 testing-related sales, Core Laboratory Diagnostics sales increased 10.7 percent and Molecular Diagnostics sales increased 31.5 percent on an organic basis in the first quarter. 3

Established Pharmaceuticals
($ in millions)









% Change vs. 1Q20



Sales 1Q21


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


--


1,070


1,070


n/a


2.5


2.5


n/a


6.2


6.2

Key Emerging Markets


--


821


821


n/a


1.0


1.0


n/a


6.7


6.7

Other


--


249


249


n/a


7.8


7.8


n/a


4.2


4.2

Established Pharmaceuticals sales increased 2.5 percent on a reported basis in the first quarter and increased 6.2 percent on an organic basis.

Key Emerging Markets include India , Brazil , Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott's branded generics product portfolio. Sales in these geographies increased 1.0 percent on a reported basis in the quarter and increased 6.7 percent on an organic basis. Organic sales growth was led by strong growth across several geographies, including China , India and Brazil.

Other sales increased 7.8 percent on a reported basis in the quarter and increased 4.2 percent on an organic basis.

Medical Devices
($ in millions)









% Change vs. 1Q20



Sales 1Q21


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


1,351


1,969


3,320


9.6


15.6


13.1


9.6


8.2


8.8

Rhythm Management


241


278


519


5.6


13.4


9.6


5.6


6.1


5.8

Electrophysiology


179


252


431


9.3


12.3


11.0


9.3


5.5


7.1

Heart Failure


145


49


194


(4.7)


(4.3)


(4.6)


(4.7)


(10.8)


(6.2)

Vascular


219


416


635


(4.7)


5.4


1.7


(4.7)


(0.4)


(2.0)

Structural Heart


169


208


377


24.3


14.3


18.6


24.3


6.7


14.2

Neuromodulation


145


39


184


6.1


(1.4)


4.4


6.1


(8.3)


2.8

Diabetes Care


253


727


980


35.7


28.3


30.2


35.7


19.5


23.6

Worldwide Medical Devices sales increased 13.1 percent on a reported basis in the first quarter and increased 8.8 percent on an organic basis. Strong growth in the quarter was driven by continued recovery from the COVID-19 pandemic. In Diabetes Care, sales of FreeStyle ® Libre and Libre Sense were $829 million in the quarter. FreeStyle Libre now has more than 3 million users worldwide.

ABBOTT'S EARNINGS-PER-SHARE GUIDANCE
Abbott projects 2021 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of at least $3.74 . Abbott forecasts specified items for the full-year 2021 of $1.26 primarily related to intangible amortization, expenses associated with acquisitions, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be at least $5.00 for full-year 2021.

ABBOTT DECLARES 389 TH CONSECUTIVE QUARTERLY DIVIDEND  
On Feb. 19, 2021 , the board of directors of Abbott declared the company's quarterly dividend of $0.45 per share. Abbott's cash dividend is payable May 17, 2021 to shareholders of record at the close of business on April 15, 2021 .

Abbott has increased its dividend payout for 49 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

About Abbott:  
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews .

Abbott will live webcast its first-quarter earnings conference call through its Investor Relations website at www.abbottinvestor.com at 8:30 a.m. Central time today. An archived edition of the webcast will be available later that day.

  Private Securities Litigation Reform Act of 1995 —
  A Caution Concerning Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, "Risk Factors" in our Annual Report on Form 10-K for the year ended Dec. 31, 2020 , and are incorporated herein by reference. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.  

1 First-quarter 2021 diluted EPS from continuing operations on a GAAP basis reflects 233.3 percent growth.
2 Full-year 2021 guidance for diluted EPS from continuing operations on a GAAP basis reflects growth of at least 50 percent versus the prior year.
3 Excluding COVID-19 testing-related sales, Core Laboratory Diagnostics sales increased 14.1 percent and Molecular Diagnostics sales increased 33.9 percent on a reported basis in the first quarter.

Abbott Laboratories and Subsidiaries

Condensed Consolidated Statement of Earnings

First Quarter Ended March 31, 2021 and 2020

(in millions, except per share data)

(unaudited)




1Q21


1Q20


%
Change


Net Sales


$10,456


$7,726


35.3










Cost of products sold, excluding amortization expense


4,401


3,281


34.1


Amortization of intangible assets


509


561


(9.2)


Research and development


654


578


13.3


Selling, general, and administrative


2,783


2,548


9.2


Total Operating Cost and Expenses


8,347


6,968


19.8










Operating Earnings


2,109


758


178.0










Interest expense, net


124


121


2.2


Net foreign exchange (gain) loss


3


5


(44.7)


Other (income) expense, net


(61)


(1)


n/m


Earnings from Continuing Operations before taxes


2,043


633


222.7










Tax expense on Earnings from Continuing Operations


250


89


180.6

1)

Earnings from Continuing Operations


1,793


544


229.5










Earnings from Discontinued Operations, net of taxes


--


20


n/m










Net Earnings


$1,793


$564


217.8










Earnings from Continuing Operations, excluding








Specified Items, as described below


$2,368


$1,162


103.8

2)









Diluted Earnings per Common Share from:








Continuing Operations


$1.00


$0.30


233.3


Discontinued Operations


--


0.01


n/m


Total


$1.00


$0.31


222.6










Diluted Earnings per Common Share from Continuing








Operations, excluding Specified Items, as described below


$1.32


$0.65


103.1

2)









Average Number of Common Shares Outstanding








Plus Dilutive Common Stock Options


1,792


1,781




















NOTES:

See tables titled "Non-GAAP Reconciliation of Financial Information From Continuing Operations" for an explanation of certain non-GAAP financial information.

n/m = Percent change is not meaningful.

See footnotes on the following table.



1)

2021 Tax expense on Earnings from Continuing Operations includes the recognition of approximately $80 million in excess tax benefits associated with share-based compensation.



2)

2021 Net Earnings and Diluted Earnings per Common Share from Continuing Operations, excluding Specified Items, excludes net after-tax charges of $575 million, or $0.32 per share, for intangible amortization and other net expenses primarily associated with certain litigation, acquisitions and restructuring actions.




2020 Net Earnings and Diluted Earnings per Common Share from Continuing Operations, excluding Specified Items, excludes net after-tax charges of $618 million, or $0.35 per share, for intangible amortization expense and other expenses primarily associated with acquisitions and restructuring actions.

Abbott Laboratories and Subsidiaries

Non-GAAP Reconciliation of Financial Information From Continuing Operations

First Quarter Ended March 31, 2021 and 2020

(in millions, except per share data)

(unaudited)




1Q21



As
Reported
(GAAP)


Specified
Items


As
Adjusted


% to
Sales










Intangible Amortization


$            509


$     (509)


$          --



Gross Margin


5,546


549


6,095


58.3%

R&D


654


(28)


626


6.0%

SG&A


2,783


(154)


2,629


25.1%

Other (income) expense, net


(61)


(12)


(73)



Earnings from Continuing Operations before taxes


2,043


743


2,786



Tax expense on Earnings from Continuing Operations


250


168


418



Earnings from Continuing Operations


1,793


575


2,368



Diluted Earnings per Share from Continuing Operations


$1.00


$0.32


$1.32





Specified items reflect intangible amortization expense of $509 million and other net expenses of $234 million, primarily associated with certain litigation, acquisitions, restructuring actions and other expenses. See tables titled "Details of Specified Items" for additional details regarding specified items.




1Q20



As
Reported
(GAAP)


Specified
Items


As
Adjusted


% to
Sales










Intangible Amortization


$            561


$      (561)


$          --



Gross Margin


3,884


599


4,483


58.0%

R&D


578


(15)


563


7.3%

SG&A


2,548


(58)


2,490


32.2%

Other (income) expense, net


(1)


(42)


(43)



Earnings from Continuing Operations before taxes


633


714


1,347



Tax expense on Earnings from Continuing Operations


89


96


185



Earnings from Continuing Operations


544


618


1,162



Diluted Earnings per Share from Continuing Operations


$0.30


$0.35


$0.65




Specified items reflect intangible amortization expense of $561 million and other expenses of $153 million, primarily associated with acquisitions, restructuring actions and other expenses. See tables titled "Details of Specified Items" for additional details regarding specified items.

A reconciliation of the first-quarter tax rates for continuing operations for 2021 and 2020 is shown below:




1Q21

($ in millions)


Pre-Tax
Income


Taxes on
Earnings


Tax
Rate

As reported (GAAP)


$2,043


$         250


12.2%

Specified items


743


168



Excluding specified items


$2,786


$418


15.0%












1Q20

($ in millions)


Pre-Tax
Income


Taxes on
Earnings


Tax
Rate

As reported (GAAP)


$633


$89


14.0%

Specified items


714


96



Excluding specified items


$1,347


$185


13.7%



1)

2021 Tax expense on Earnings from Continuing Operations includes the recognition of approximately $80 million in excess tax benefits associated with share-based compensation.

Abbott Laboratories and Subsidiaries

Details of Specified Items

First Quarter Ended March 31, 2021

(in millions, except per share data)

(unaudited)




Acquisition or
Divestiture-
related (a)


Restructuring
and Cost
Reduction
Initiatives (b)


Intangible
Amortization


Other (c)


Total
Specifieds


Gross Margin


$               19


$              19


$           509


2


$       549


R&D


(2)


--


--


(26)


(28)


SG&A


(13)


(1)


--


(140)


(154)


Other (income) expense, net


--


1


--


(13)


(12)


Earnings from Continuing Operations before taxes


$               34


$              19


$           509


$      181


743


Tax expense on Earnings from Continuing Operations (d)










168


Earnings from Continuing Operations










$       575


Diluted Earnings per Share from Continuing Operations










$      0.32














The table above provides additional details regarding the specified items described on table titled "Non-GAAP Reconciliation of Financial Information From Continuing Operations."


a)

Acquisition-related expenses include integration costs, which represent incremental costs directly related to integrating the acquired businesses and include expenditures for the integration of systems, processes and business activities.

b)

Restructuring and cost reduction initiative expenses include severance, outplacement, and other direct costs associated with specific restructuring plans and cost reduction initiatives. Restructuring and cost reduction plans consist of distinct initiatives to streamline operations including the consolidation and rationalization of business activities and facilities, workforce reductions, the transfer of product lines between manufacturing facilities, and the transfer of other business activities between sites.

c)

Other primarily relates to the net costs related to certain litigation, the acquisition of a research and development asset, and the impairment of an equity investment.

d)

Reflects the net tax benefit associated with the specified items and excess tax benefits associated with share-based compensation.

Abbott Laboratories and Subsidiaries

Details of Specified Items

First Quarter Ended March 31, 2020

(in millions, except per share data)

(unaudited)




Acquisition or
Divestiture-
related (a)


Restructuring
and Cost
Reduction
Initiatives (b)


Intangible
Amortization


Other (c)


Total
Specifieds

Gross Margin


$               23


$              15


$           561


$         --


$       599

R&D


(4)


(6)


--


(5)


(15)

SG&A


(28)


(30)


--


--


(58)

Other (income) expense, net


2


--


--


(44)


(42)

Earnings from Continuing Operations before taxes


$               53


$              51


$           561


$        49


714

Tax expense on Earnings from Continuing Operations (d)










96

Earnings from Continuing Operations










$       618

Diluted Earnings per Share from Continuing Operations










$      0.35



The table above provides additional details regarding the specified items described on table titled "Non-GAAP Reconciliation of Financial Information From Continuing Operations."


a)

Acquisition-related expenses include integration costs, which represent incremental costs directly related to integrating the acquired business and include expenditures for retention, severance, and the integration of systems, processes and business activities.

b)

Restructuring and cost reduction initiative expenses include severance, outplacement, and other direct costs associated with specific restructuring plans and cost reduction initiatives. Restructuring and cost reduction plans consist of distinct initiatives to streamline operations including the consolidation and rationalization of business activities and facilities, workforce reductions, the transfer of product lines between manufacturing facilities, and the transfer of other business activities between sites.

c)

Other primarily relates to the impairment of an investment.

d)

Reflects the net tax benefit associated with the specified items and excess tax benefits associated with share-based compensation.

Cision View original content: https://www.prnewswire.com/news-releases/abbott-reports-first-quarter-2021-results-301272437.html

SOURCE Abbott

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  • Dual-energy (RF/PF), focal Sphere-9™ catheter demonstrates efficacy for linear ablation in persistent AFib
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Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera™ family of technologies, including the next-generation Sphere-360™ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9™ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .

(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

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Sphere-9 for Linear Ablation

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AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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SOURCE Medtronic plc

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Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery   in the U.S. presented as a late-breaker at the American Urologic Association annual meeting

Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration

Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo™ robotic-assisted surgery (RAS) system.

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Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html

SOURCE Medtronic plc

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