SRSEC Reporting Desk

Industries

Medical Devices & Supplies

7 SEC staff comments and 9 disclosure examples from companies in this industry.

SIC codes included: 3841 Surgical & Medical Instruments & Apparatus, 3845 Electromedical & Electrotherapeutic Apparatus, 3842 Orthopedic, Prosthetic & Surgical Appliances & Supplies, 3851 Ophthalmic Goods, 3844 X-Ray Apparatus & Tubes & Related Irradiation Apparatus

Disclosure examples by topic

Medical Devices & Supplies: Leases (ASC 842)1 exampleMedical Devices & Supplies: Pay versus performance1 exampleMedical Devices & Supplies: Critical accounting estimates (MD&A)1 exampleMedical Devices & Supplies: Supplier finance programs (ASU 2022-04)1 exampleMedical Devices & Supplies: Derivatives & hedging (ASC 815)1 exampleMedical Devices & Supplies: Business combinations (ASC 805)1 exampleMedical Devices & Supplies: Discontinued operations (ASC 205-20)1 exampleMedical Devices & Supplies: Credit losses (CECL, ASC 326)1 exampleMedical Devices & Supplies: Stock-based compensation (ASC 718)1 example

What the SEC staff asked companies in this industry

Segment Reporting (ASC 280) (2)MD&A: Results & Known Trends (1)Insurance & Credit Loss Reserves (1)Concentrations & Receivables (1)ASC 606: Revenue Recognition (1)Auditor & Audit Report (1)Exhibits, Certifications & Signatures (1)Non-GAAP: Adjustments & Labels (1)Non-GAAP: Reconciliation & Usefulness (1)Business Description (Item 101) (1)

INSULET CORP (PODD) · 2026-03-17 · Form 10-K for Fiscal Year Ended December 31, 2025 Filed February 18, 2026 · Comment 1 · Note 3. Segment and Geographic Data, page 53 Agreed to revise
Staff comment: Please expand your disclosures to explain how the CODM uses consolidated operating income and net income in assessing each segment’s performance and deciding how to allocate resources. Refer to the guidance in ASC 280-10-50-29(f) along with the example in ASC 280-10-55-47(bb). letter →
Company response: In response to the Staff’s comment, the Company will revise its segment and geographic data disclosure to include the following statement beginning with its Form 10-Q for the first quarter of 2026: The Company’s CODM uses operating income and net income to monitor actual results against forecast and budget to identify business trends, assess operating performance, and modify capital allocation as necessary. The Company acknowledges that it and its management are responsible for the accuracy and adequacy of its disclosures, notwithstanding any review, comments, actions or absence of action by the Staff. Please do not hesitate to contact us with any questions or comments you may have. response letter →
Segment Reporting (ASC 280)
Electromed, Inc. (ELMD) · 2026-03-16 · Form 10-K For the Fiscal Year Ended June 30, 2025 Filed August 26, 2025 · Comment 1 · Results of Operations, page 16 Awaiting / response not in dataset
Staff comment: We note the increase in Homecare revenue was due to an increase in direct sales representatives and higher net revenues per approval. Please describe for us and in future filings the amount of increase that is due to higher volume versus higher net revenues per approval. Please also describe the reasons for the higher net revenues per approval. letter →
MD&A: Results & Known Trends
Electromed, Inc. (ELMD) · 2026-03-16 · Form 10-K For the Fiscal Year Ended June 30, 2025 Filed August 26, 2025 · Comment 2 · Accounts Receivable, page F-8 Awaiting / response not in dataset
Staff comment: Please provide us and in future filings a rollforward of the allowance for credit losses, as set forth in ASC 326-20-50-13. In addition, please provide us and in future filings the amount of accounts receivable that have been outstanding for greater than one year for the Balance Sheet dates presented and December 31, 2025. letter →
Insurance & Credit Loss ReservesConcentrations & Receivables
Electromed, Inc. (ELMD) · 2026-03-16 · Form 10-K For the Fiscal Year Ended June 30, 2025 Filed August 26, 2025 · Comment 3 · Note 2. Revenues, page F-11 Awaiting / response not in dataset
Staff comment: Please provide us and in future filings the qualitative and quantitative disclosures related to the significant judgments, and changes in judgments, including information related to inputs and assumptions, as it relates to you estimating variable consideration. Refer to ASC 606-10-50-1(b), 50-17(b), and 50-20. As a related matter, consider disclosing in future filings the amount of capped installment payments as you disclose that the related transactions constitute a primary portion of your variable consideration. letter →
ASC 606: Revenue Recognition
WORK Medical Technology Group LTD (WOK) · 2026-03-12 · 20-F filed January 30, 2026 · Comment 1 · Item 19, page 155 Agreed to revise
Staff comment: Please revise the accountant's consent in Exhibit 15.2 to include the complete file number of the Form F-3. Also, please include a consent that covers the audit report on your September 30, 2025 financial statements. See the guidance in Item 6 of Form F-3. letter →
Company response: to the Staff’s comments, our former auditor, WWC, P.C. has revised Exhibit 15.2 to include the complete file number on Form F-3 (File No. 333-289943), filed with the Commission on August 29, 2025 and went effect on September 15, 2025. In addition, our current auditor, HTL International, LLC, has provided their consent in a separate Exhibit 15.3 covering the audit report relating to our consolidated financial statements for the year ended September 30, 2025. We have filed Amendment No. 1 to Form 20-F to reflect these revisions. We appreciate the assistance the Staff has provided with its comments. response letter →
Auditor & Audit ReportExhibits, Certifications & Signatures
COOPER COMPANIES, INC. (COO) · 2026-01-27 · Form 10-K for Fiscal Year Ended October 31, 2025 Filed December 05, 2025 · Comment 1 · Note 12. Business Segment Information, page 85 Agreed to revise
Staff comment: Please expand your disclosures to explain how the CODM uses operating income, the reported measure of segment profit or loss, in assessing each segment’s performance and deciding how to allocate resources. Refer to the guidance in ASC 280-10-50-29(f) along with the example in ASC 280-10-55-47(bb). letter →
Company response: We respectfully acknowledge the Staff’s comment and will enhance our disclosure prospectively, beginning with our Form 10-Q for the quarter ended January 31, 2026 as follows (the use of italics indicates existing disclosures and the use of bold indicates additions): The CODM uses operating income, as presented in our financial reports, as the primary measure of segment profitability to assess the performance of the segments and make decisions on resource allocation across segments. The CODM evaluates segment operating income on a quarterly basis by comparing actual results to forecasted amounts and historical performance. These evaluations, supported by discussions with the leadership team… response letter →
Segment Reporting (ASC 280)
MASIMO CORP (MASI) · 2025-11-13 · oration Item 2.02 Form 8-K filed February 25, 2025 Response dated August 6, 2025 · Comment 1 · Staff’s comment is repeated below in bold, followed by the Company’s response. Awaiting / response not in dataset
Staff comment: We have reviewed your supplemental information letter. We continue to believe that the expenses associated with your consumer products inventory write-downs represent costs that are normal operating costs of your business. Please revise future filings to not include these adjustments to your non-GAAP performance measures. See Question 100.01 of the SEC's Non-GAAP Financial Measures Compliance and Disclosure Interpretations (“CD&I”). The Company respectfully acknowledges the Staff’s comment and, although the Company believes that its consumer products inventory write-down adjustments were appropriate and complied with Question 100.01 of the SEC’s Non-GAAP Financial Measures CD&I, the Company… letter →
Non-GAAP: Adjustments & LabelsNon-GAAP: Reconciliation & UsefulnessBusiness Description (Item 101)

Templates & resources

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