IRMD — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-10-30

• Unless otherwise indicated, dollar amounts in the tables in this Item 2 are presented in thousands, and dollar amounts in the narrative discussion are presented in millions, rounded to one decimal place, or in thousands where so indicated. Percentage changes and percentages of total revenue are calc…

• In February 2026, the Supreme Court of the United States held that the International Emergency Economic Powers Act (“IEEPA”) does not authorize the President to impose tariffs, invalidating certain tariffs imposed under that statute. Subsequent administrative and judicial developments have establish…

• The Company has submitted refund claims for IEEPA tariffs paid on certain imported materials and components and has received refunds, which did not have a material impact on its financial condition or results of operations for the three and nine months ended September 30, 2026. The Company continues…

• The discussion and analysis of our financial condition and results of operations are based on our unaudited condensed financial statements, which we have prepared in accordance with GAAP. The preparation of these unaudited condensed financial statements requires us to make estimates and assumptions …

• statements as well as the reported revenue and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which…

Text removed vs the prior filing · source: 10-Q · 2026-07-31

• In February 2026, the Supreme Court of the United States issued a ruling determining that certain tariffs were not lawfully imposed. As a result of this decision, impacted importers may be entitled to seek refunds of previously paid tariffs, subject to applicable administrative processes and further…

• The discussion and analysis of our financial condition and results of operations are based on our unaudited condensed financial statements, which we have prepared in accordance with GAAP. The preparation of these unaudited condensed financial statements requires us to make estimates and assumptions …

• We believe that the estimates, assumptions and judgments involved in the accounting policies described in “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our 2025 Annual Report have the greatest potential impact on our financial statements,…

• MRI Compatible Patient Vital Signs Monitoring Systems6,665 5,944 13,772 12,489

• Amortization of extended maintenance agreements758 592 1,417 1,153

Text added vs the prior filing · source: 10-Q · 2026-10-30

• This Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 (this "Quarterly Report") contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as ame…

• All forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to:

• •our ability to obtain or maintain regulatory approvals and comply with applicable regulations, including 510(k) clearances for our products and product candidates, the outcome of inspections conducted by the U.S. Food and Drug Administration (the “FDA”) or other regulatory bodies, additional action…

• •our reliance on a limited number of products and our ability to identify and pursue development of additional products;

• •our ability to retain key management, marketing, and scientific personnel and to attract and retain additional qualified personnel;

Text removed vs the prior filing · source: 10-Q · 2026-07-31

• Certain statements contained in this Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 (this "Quarterly Report") that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"),…

• •our ability to obtain and/or maintain regulatory approvals and comply with applicable regulations, including, our ability to receive 510(k) clearance for our products and product candidates, complete inspections conducted by the U.S. Food & Drug Administration (“FDA”) or other regulatory bodies wit…

• •the timing and likelihood of regulatory approvals or clearances from the FDA or other regulatory bodies and regulatory actions on our product candidates and product marketing activities;

• •unexpected costs, expenses and diversion of management attention resulting from actions or requests posed to us by the FDA or other regulatory bodies;

• •our primary reliance on a limited number of products and our ability to identify and pursue development of additional products;

Text added vs the prior filing · source: 10-Q · 2026-10-30

• This Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 (this "Quarterly Report") contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as ame…

• All forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to:

• •our ability to obtain or maintain regulatory approvals and comply with applicable regulations, including 510(k) clearances for our products and product candidates, the outcome of inspections conducted by the U.S. Food and Drug Administration (the “FDA”) or other regulatory bodies, additional action…

• •our reliance on a limited number of products and our ability to identify and pursue development of additional products;

• •our ability to retain key management, marketing, and scientific personnel and to attract and retain additional qualified personnel;

Text removed vs the prior filing · source: 10-Q · 2026-07-31

• Certain statements contained in this Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 (this "Quarterly Report") that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"),…

• •our ability to obtain and/or maintain regulatory approvals and comply with applicable regulations, including, our ability to receive 510(k) clearance for our products and product candidates, complete inspections conducted by the U.S. Food & Drug Administration (“FDA”) or other regulatory bodies wit…

• •the timing and likelihood of regulatory approvals or clearances from the FDA or other regulatory bodies and regulatory actions on our product candidates and product marketing activities;

• •unexpected costs, expenses and diversion of management attention resulting from actions or requests posed to us by the FDA or other regulatory bodies;

• •our primary reliance on a limited number of products and our ability to identify and pursue development of additional products;

Text added vs the prior filing · source: 10-Q · 2026-10-30

• This Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 (this "Quarterly Report") contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as ame…

• All forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to:

• •our ability to obtain or maintain regulatory approvals and comply with applicable regulations, including 510(k) clearances for our products and product candidates, the outcome of inspections conducted by the U.S. Food and Drug Administration (the “FDA”) or other regulatory bodies, additional action…

• •our reliance on a limited number of products and our ability to identify and pursue development of additional products;

• •our ability to retain key management, marketing, and scientific personnel and to attract and retain additional qualified personnel;

Text removed vs the prior filing · source: 10-Q · 2026-07-31

• Certain statements contained in this Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 (this "Quarterly Report") that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"),…

• •our ability to obtain and/or maintain regulatory approvals and comply with applicable regulations, including, our ability to receive 510(k) clearance for our products and product candidates, complete inspections conducted by the U.S. Food & Drug Administration (“FDA”) or other regulatory bodies wit…

• •the timing and likelihood of regulatory approvals or clearances from the FDA or other regulatory bodies and regulatory actions on our product candidates and product marketing activities;

• •unexpected costs, expenses and diversion of management attention resulting from actions or requests posed to us by the FDA or other regulatory bodies;

• •our primary reliance on a limited number of products and our ability to identify and pursue development of additional products;

Text added vs the prior filing · source: 10-Q · 2026-10-30

• This Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 (this "Quarterly Report") contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as ame…

• All forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to:

• •our ability to obtain or maintain regulatory approvals and comply with applicable regulations, including 510(k) clearances for our products and product candidates, the outcome of inspections conducted by the U.S. Food and Drug Administration (the “FDA”) or other regulatory bodies, additional action…

• •our reliance on a limited number of products and our ability to identify and pursue development of additional products;

• •our ability to retain key management, marketing, and scientific personnel and to attract and retain additional qualified personnel;

Text removed vs the prior filing · source: 10-Q · 2026-07-31

• Certain statements contained in this Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 (this "Quarterly Report") that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"),…

• •our ability to obtain and/or maintain regulatory approvals and comply with applicable regulations, including, our ability to receive 510(k) clearance for our products and product candidates, complete inspections conducted by the U.S. Food & Drug Administration (“FDA”) or other regulatory bodies wit…

• •the timing and likelihood of regulatory approvals or clearances from the FDA or other regulatory bodies and regulatory actions on our product candidates and product marketing activities;

• •unexpected costs, expenses and diversion of management attention resulting from actions or requests posed to us by the FDA or other regulatory bodies;

• •our primary reliance on a limited number of products and our ability to identify and pursue development of additional products;

Text added vs the prior filing · source: 10-Q · 2026-10-30

• This Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 (this "Quarterly Report") contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as ame…

• All forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to:

• •our ability to obtain or maintain regulatory approvals and comply with applicable regulations, including 510(k) clearances for our products and product candidates, the outcome of inspections conducted by the U.S. Food and Drug Administration (the “FDA”) or other regulatory bodies, additional action…

• •our reliance on a limited number of products and our ability to identify and pursue development of additional products;

• •our ability to retain key management, marketing, and scientific personnel and to attract and retain additional qualified personnel;

Text removed vs the prior filing · source: 10-Q · 2026-07-31

• Certain statements contained in this Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 (this "Quarterly Report") that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"),…

• •our ability to obtain and/or maintain regulatory approvals and comply with applicable regulations, including, our ability to receive 510(k) clearance for our products and product candidates, complete inspections conducted by the U.S. Food & Drug Administration (“FDA”) or other regulatory bodies wit…

• •the timing and likelihood of regulatory approvals or clearances from the FDA or other regulatory bodies and regulatory actions on our product candidates and product marketing activities;

• •unexpected costs, expenses and diversion of management attention resulting from actions or requests posed to us by the FDA or other regulatory bodies;

• •our primary reliance on a limited number of products and our ability to identify and pursue development of additional products;