Allurion (NYSE: ALUR) secures FDA PMA for Smart Capsule obesity device
Rhea-AI Filing Summary
Allurion Technologies reported that the U.S. Food and Drug Administration granted premarket approval for the Allurion Gastric Balloon System, featuring the Allurion Smart Capsule, for adults aged 22–65 with obesity and a BMI between 30 and 40 kg/m2 after at least one unsuccessful weight-loss attempt.
The Smart Capsule is swallowed in a brief office visit, forms a gastric balloon that remains in the stomach for about four months, then empties and passes naturally, with the option for a second capsule within a 10‑month treatment period. Allurion estimates this indication provides access to roughly 80 million Americans within the approved BMI range.
The company highlights prior use of the Smart Capsule outside the United States in over 200,000 patients and cites published data showing around 14% total body weight loss with one balloon cycle and over 20% with two cycles or when combined with low‑dose GLP‑1 therapies. Allurion also notes risks around maintaining FDA approval, successful commercialization, and obtaining sufficient financing to continue as a going concern.
Positive
- FDA PMA approval for core product: The Allurion Gastric Balloon System, featuring the Smart Capsule, received premarket approval for adults with BMI 30–40 kg/m2, a stringent regulatory clearance that underpins U.S. commercialization.
- Large stated addressable U.S. population: Allurion estimates approximately 80 million Americans fall within the approved BMI range, providing a sizable potential market for its non‑surgical obesity treatment.
- Extensive non‑U.S. usage and supportive data: The Smart Capsule has been used in over 200,000 patients outside the United States, with cited studies reporting around 14% total body weight loss with one cycle and over 20% with repeat cycles or GLP‑1 combinations.
Negative
- Financing and going‑concern risks: Allurion discloses the need to identify and evaluate financing opportunities, notes risk that capital raising may not occur on attractive terms or at all, and explicitly references its ability to obtain sufficient financing to continue as a going concern.
- Regulatory and commercialization uncertainty: The company cites risks around maintaining FDA approval of the Allurion Gastric Balloon System and successfully commercializing the Smart Capsule in a competitive and evolving obesity‑treatment landscape.
Insights
FDA PMA approval validates Allurion’s device and opens a large U.S. obesity market.
The approval of the Allurion Gastric Balloon System with Smart Capsule is a major regulatory milestone. PMA is the FDA’s most stringent device pathway, and clearance for adults with BMI 30–40 kg/m2 targets roughly
Allurion brings real‑world experience from more than 200,000 treated patients outside the United States, with cited studies showing about
The company, however, explicitly warns about its ability to maintain FDA approval, commercialize the system, and secure financing to continue as a going concern. Execution on U.S. commercialization, clinical data generation and reimbursement, and disclosed capital‑raising plans will be critical areas addressed in future SEC filings.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On February 23, 2026, Allurion Technologies, Inc. (the “Company” or “Allurion”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) granted PMA approval for the Allurion Gastric balloon system, featuring the Allurion Smart Capsule for the treatment of adults with obesity between the ages of 22 years and 65 years with a body mass index (BMI) ≥ 30 kg/m2 and ≤ 40 kg/m2 who have had at least one unsuccessful attempt at a weight loss program. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.
Forward-Looking Statements
This Current Report on Form 8-K and the press release attached as Exhibit 99.1 hereto contain forward-looking statements that reflect Allurion’s beliefs and assumptions based on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terms, although not all forward-looking statements contain these words. Although Allurion believes it has a reasonable basis for each forward-looking statement contained in this Current Report on Form 8-K and the press release, these statements involve risks and uncertainties that may cause actual results or the timing of events to be materially different from the information expressed or implied by these forward-looking statements.
Forward-looking statements in this Current Report on Form 8-K and press release include, but are not limited to, statements related to the anticipated commercialization of the Allurion Smart Capsule in the United States and other statements about future events that reflect the current beliefs and assumptions of Allurion’s management based on information currently available to management.
Allurion cannot assure you that the forward-looking statements in this Current Report on Form 8-K will prove to be accurate. These forward looking statements are subject to a number of risks and uncertainties, including, among others, the Company’s ability to maintain FDA approval of the Allurion Gastric Balloon system, commercialize the Allurion Smart Capsule and identify and evaluate possible financing opportunities to support such approval and commercialization; the risk that the capital raising process will not result in the Company pursuing any transactions or that any transaction, if pursued, will be completed on attractive terms or at all; the ability of the Company to obtain sufficient financing to continue as a going concern and those risks and uncertainties discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 27, 2025, and as amended on August 19, 2025, and updated from time to time by its other filings with the SEC, and its Quarterly Report on Form 10-Q filed with the SEC on November 17, 2025. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Allurion undertakes no obligation to update any forward-looking statements to reflect any new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events, other than as required by applicable law.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Press Release dated February 23, 2026. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ALLURION TECHNOLOGIES, INC. |
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February 23, 2026 |
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/s/ Brendan M. Gibbons |
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Brendan M. Gibbons |
Exhibit 99.1
Allurion Receives U.S. FDA Approval for the Allurion Gastric Balloon System, Featuring the Allurion Smart Capsule
Approval provides Allurion with access to approximately 80 million Americans with obesity
NATICK, Mass. – February 23, 2026 – Allurion Technologies, Inc. (NYSE: ALUR), a pioneer in metabolically healthy weight loss, today announced that the U.S. Food and Drug Administration (FDA) has approved the premarket approval (PMA) application for the Allurion Gastric Balloon System, featuring the Allurion Smart Capsule.
“Today’s approval is a watershed moment for Allurion and for obesity care in the United States,” said Dr. Shantanu Gaur, Founder and Chief Executive Officer. “Our goal is to deliver patients metabolically healthy weight loss by helping them lose weight, keep it off, and maintain muscle. The Allurion Smart Capsule offers a safe and effective alternative to GLP-1s and bariatric surgery, and we expect it to become a mainstay in the comprehensive treatment of obesity in the United States.”
The Allurion Smart Capsule is a state-of-the-art innovation in obesity care covered by over 50 patents globally. The Smart Capsule is swallowed in a 15-minute office visit without the need for surgery, endoscopy, or anesthesia and is filled with fluid, creating a gastric balloon that resides inside the stomach for approximately four months. During that time, the balloon occupies space within the stomach, helping patients feel full and eat less. After approximately four months, the balloon’s patented Release Valve opens, and the balloon empties and passes out of the body naturally. Another Smart Capsule can then be swallowed approximately two months after the passage of the first. Unlike medications that need to be administered daily or injected weekly, the Allurion Smart Capsule results in approximately four months of treatment effect from a single administration.
In the United States, over 100 million Americans have obesity, with approximately 80 million falling within a body mass index (BMI) range of 30 to 40 kg/m2, the approved range for treatment with the Allurion Smart Capsule. It is estimated that approximately 20 million Americans have already started and stopped GLP-1s and that this number will grow to 40 million by 2027.1 Previous studies have shown that 65% of patients discontinue GLP-1s within the first year, primarily due to side effects, and then rapidly regain weight.2,3
“Obesity is a critical issue in the United States and many patients are looking for alternatives or complements to existing options, especially GLP-1 medications,” said Dr. Shelby Sullivan, Professor of Medicine at the Geisel School of Medicine at Dartmouth University and Principal Investigator on the AUDACITY FDA pivotal trial. “The AUDACITY trial results coupled with the real-world experience for the Allurion Smart Capsule outside the United States demonstrate its safety and efficacy. The Allurion Smart Capsule offers an option that many people are looking for. It is completely reversible, but repeatable over time when needed, and it does not require patients to take long-term medications for weight loss. I believe this innovation will be welcomed by providers and patients in the United States in need of additional treatments for obesity.”
Outside the United States, the Allurion Smart Capsule has already been used to treat over 200,000 patients with results reported in over 30 peer-reviewed medical journal publications. In a commercial setting outside the United
3 West et al. BMJ. 2026;392:e085304.
1 New England Consulting Group. Data on file.
2 Almohaileb FI et al. Diabetes Obes Metab. 2025; 27(9): 5342-5345.
States, when combined with the Allurion Virtual Care Suite featuring Allurion’s AI-powered behavior change program and personalized follow-up from the physician’s care team, data demonstrate that patients achieve total body weight loss of 14%4 and over 20% with two balloon cycles.5 When combined with a low dose of GLP-1s, patients treated with the Allurion Smart Capsule and Virtual Care Suite achieve a total body weight loss of over 20% with favorable improvements in muscle mass.6
More invasive options like bariatric surgery exist for patients with more advanced obesity, but only 1% of patients who qualify for bariatric surgery actually proceed with an operation, leaving most patients looking for treatment alternatives.7
“The Allurion Smart Capsule is an important tool within the continuum of obesity care,” said Dr. Jaime Ponce, President and Medical Director of the Weight Loss Center of Chattanooga and former President of the American Society for Metabolic and Bariatric Surgery (ASMBS). “For patients with a BMI between 30 and 40 seeking meaningful health improvements, the Allurion Smart Capsule could be an attractive option, especially for those seeking a structured alternative to medications or surgery.”
About Allurion
Allurion is a pioneer in metabolically healthy weight loss. The Allurion Program is a weight-loss platform that combines the FDA PMA approved Allurion Gastric Balloon System, featuring the Allurion Smart Capsule—the world’s first and only swallowable, ProcedurelessTM gastric balloon for weight loss—with the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers and Allurion Insights for healthcare providers featuring the Iris AI Platform, and the Allurion Connected Scale.
In the United States, the Allurion Gastric Balloon System (AGBS) is indicated to promote short-term limited weight loss in adult individuals with obesity between the ages of 22 years and 65 years with a body mass index (BMI) ≥ 30 kg/m2 and ≤ 40 kg/m2 who have had at least one unsuccessful attempt at a weight loss program. The residence time for each balloon is variable with an average observed residence time of 15.3 weeks. The AGBS is to be used in conjunction with a moderate intensity lifestyle modification therapy program. The AGBS consists of up to two Allurion Balloons placed during a 10-month period.
For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com.
Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world.
Forward-Looking Statements
This press release contains forward-looking statements that reflect Allurion’s beliefs and assumptions based on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terms, although not all forward-looking statements contain these words. Although Allurion believes it has a reasonable basis for each forward-looking statement contained in this release, these statements involve risks and uncertainties that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements.
Forward-looking statements in this press release include, but are not limited to, statements regarding: our expectations relating to the use of the Allurion Gastric Balloon System (including in combination with GLP-1 therapies) to treat obesity, including with respect to its therapeutic benefits and the acceptance of Allurion’s products in the marketplace; our estimates regarding the number of patients using GLP-1 therapies; establishing a
6 Flagiello et al. Presented at IFSO 2025.
5 Caballero et al. Obesity Surgery. 2025;35(11):4737-4743.
7 Liu N, Funk LM. Ann Surg. 2020 Feb;271(2):210-211.
4 Ienca et al. Obesity Surgery. 2020;30(9):3354-3362.
new standard for weight loss; pioneering in, and providing more patients and providers access to, metabolically healthy weight loss; and other statements about future events that reflect the current beliefs and assumptions of Allurion’s management based on information currently available to management.
Allurion cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward looking statements are subject to a number of risks and uncertainties, including, among others, general economic, political and business conditions; the ability of Allurion to obtain and maintain regulatory approval for, and successfully commercialize, the Allurion Gastric Balloon System, including the Allurion Smart Capsule; the timing of, and results from, Allurion’s clinical studies and trials, including with respect to the combination of GLP-1s with the Allurion Smart Capsule; the evolution of the markets in which Allurion competes, including the impact of GLP-1 drugs; the ability of Allurion to maintain its listing on the New York Stock Exchange; a changing regulatory landscape in the highly competitive industry in which Allurion competes; the impact of the imposition of current and potential tariffs and trade negotiations, and those factors discussed under the heading “Risk Factors” in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 27, 2025, and as amended on August 19, 2025, and updated from time to time by its other filings with the SEC, and its Quarterly Report on Form 10-Q filed with the SEC on November 17, 2025. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Allurion undertakes no obligation to update any forward-looking statements to reflect any new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events, other than as required by applicable law.
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press@allurion.com
Investor Contact
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FAQ
What did Allurion Technologies (ALUR) announce in this 8-K filing?
Who is eligible for Allurion’s FDA-approved Smart Capsule treatment in the U.S.?
How does the Allurion Smart Capsule gastric balloon system work?
What weight-loss results has Allurion reported for the Smart Capsule outside the U.S.?
How large is the potential U.S. market for Allurion’s Gastric Balloon System?
What key risks did Allurion highlight alongside the FDA approval news?
Filing Exhibits & Attachments
2 documentsPress Releases
