Certification Represents Another Milestone Toward CE Mark Submission for Pivot
SAN DIEGO, CA / ACCESS Newswire / October 27, 2026 / Modular Medical, Inc. ("Modular Medical" or "the Company") (NASDAQ:MODD), a commercial-stage medical device company preparing for the full commercial launch of its next-generation Pivot tubeless patch pump, today announced that it has received a positive decision from its notified body regarding certification of its quality management system under ISO 13485:2016. The notified body is designated under the European Union Medical Device Regulation ("MDR").
"This positive decision represents another important milestone in our preparation for CE Mark submission, which we continue to target for calendar year 2027," said Jeb Besser, Chief Executive Officer of Modular Medical. "Receiving this positive decision underscores our commitment to bringing high quality diabetes technology to the European markets."
ISO 13485 is the internationally recognized standard for medical device quality management systems. Certification demonstrates, through independent audit, that Modular Medical's quality management system conforms to the applicable requirements of ISO 13485:2016 within the scope of certification. ISO 13485 certification is separate from CE marking, which requires additional regulatory review. If obtained, a CE mark under MDR requirements would allow the Company to pursue commercial distribution across the EU, subject to satisfying all applicable regulatory and operational criteria. There can be no assurance that the Company will obtain a CE mark on its anticipated timeline or at all.
About Modular Medical
Modular Medical, Inc. (NASDAQ:MODD) is a commercial-stage medical device company focused on the development of innovative insulin delivery technologies designed to simplify diabetes management and increase access to insulin pump therapy. The Company's Pivot tubeless patch pump has been developed to provide a user-friendly, flexible, and accessible approach to insulin delivery for people requiring intensive insulin therapy.
About Pivot
The Pivot tubeless patch pump is designed to offer a simplified approach to insulin delivery for individuals requiring intensive insulin therapy. Pivot was developed to address barriers that have limited broader adoption of insulin pump therapy among patients currently managing diabetes with multiple daily injections.
For more information, visit www.pivotpump.com.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statements contained in this press release, including but not limited to, the timing of issuance of the Company's ISO 13485:2016 certificate, the Company's ability to maintain ISO 13485:2016 certification, the timing and outcome of the Company's planned CE Mark submission and any related notified body review, the Company's ability to obtain CE marking and commercialize the Pivot insulin delivery system in the European Union, the successful development of Modular Medical's proprietary technologies, whether the market will accept Modular Medical's products and services, anticipated consumer demand for the Company's products, whether Modular Medical can successfully manufacture its products at high volumes, and general economic, and industry or political conditions in the United States or internationally, as well as other risk factors and business considerations described in Modular Medical's SEC filings, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. Any forward-looking statements in this press release should be evaluated in light of these important risk factors. In addition, any forward-looking statements included in this press release represent Modular Medical's views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. Modular Medical assumes no obligation to update these forward-looking statements, except as required by law.
Pivot is a trademark of Modular Medical. All other trademarks mentioned herein are the property of their respective owners.
Company Contact
Jeb Besser, Chief Executive Officer
Modular Medical, Inc.
IR@modular-medical.com
Investor Contact
Valter Pinto, Managing Director
KCSA Strategic Communications
ModularMedical@KCSA.com
SOURCE: Modular Medical, Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/modular-medical-announces-positive-notified-body-decision-on-iso-1348-1242608
