Modular Medical Submits Pivot Tubeless Insulin Patch Pump for FDA 510(k) Clearance
Modular Medical (NASDAQ:MODD) submitted its next-generation Pivot tubeless insulin patch pump for FDA 510(k) clearance on November 14, 2025 and expects to commence commercial launch in Q1 2026 upon clearance. The Pivot features a 3 ml removable reservoir, a two-part detachable design (removable for showering/activities) and bolus capability without a separate controller. Manufacturing conversion is validated and on track for launch readiness. The company noted an FDA submission delay due to the U.S. government shutdown and expects initial FDA questions in Q4 2025. The Pivot is not currently cleared for sale by the FDA.
Modular Medical (NASDAQ:MODD) ha presentato la sua patch pump tubeless di insulina Pivot di prossima generazione per l'autorizzazione FDA 510(k) il 14 novembre 2025 e prevede di avviare il lancio commerciale nel Q1 2026 una volta ottenuta l'autorizzazione. Il Pivot è dotato di un serbatoio rimovibile da 3 ml, di un design a due parti staccabile (rimovibile per doccia/attività) e di una capacità bolo senza un controller separato. La conversione della produzione è valida e in linea per la prontezza al lancio. L'azienda ha segnalato un ritardo nella presentazione FDA a causa della chiusura del governo degli Stati Uniti e prevede le prime domande della FDA nel Q4 2025. Il Pivot non è attualmente approvato per la vendita dalla FDA.
Modular Medical (NASDAQ:MODD) presentó su parche de insulina sin tubería Pivot de próxima generación para la aprobación FDA 510(k) el 14 de noviembre de 2025 y espera comenzar el lanzamiento comercial en el PRIMER TRIMESTRE DE 2026 una vez obtenida la aprobación. El Pivot cuenta con un depósito extraíble de 3 ml, un diseño desmontable en dos partes (extraíble para duchas/actividades) y capacidad de bolus sin un controlador separado. La conversión de fabricación está validada y en camino para la preparación del lanzamiento. La empresa señaló un retraso en el envío a la FDA debido al cierre del gobierno de EE. UU. y espera preguntas iniciales de la FDA en el CUARTO TRIMESTRE DE 2025. Actualmente, el Pivot no está aprobado para su venta por la FDA.
Modular Medical (NASDAQ:MODD)는 차세대 Pivot 무관의 인슐린 패치 펌프를 FDA 510(k) 승인을 위해 2025년 11월 14일에 제출했고, 승인이 나면 2026년 1분기에 상용 출시를 시작할 것으로 기대합니다. Pivot은 3 ml 교체 가능 저장소, 샤워/활동을 위한 제거 가능한 두 부분으로 구성된 분리형 디자인, 별도 컨트롤러 없이 볼루스 기능을 특징으로 합니다. 제조 전환은 검증되었으며 출시 준비를 위한 경로에 있습니다. 미국 정부의 셧다운으로 인한 FDA 제출 지연을 회사가 지적했으며 2025년 4분기에 초기 FDA 질의를 예상합니다. Pivot은 현재 FDA의 판매 승인 대상이 아닙니다.
Modular Medical (NASDAQ:MODD) a soumis son patch insulinique tubeless Pivot de prochaine génération pour l'autorisation FDA 510(k) le 14 novembre 2025 et prévoit de lancer commercialement au premier trimestre 2026 une fois l'autorisation obtenue. Le Pivot présente un réservoir amovible de 3 ml, un design en deux parties démontable (enlevable pour la douche/activités) et une capacité bolus sans contrôleur séparé. La conversion de la fabrication est validée et en voie d'être prête pour le lancement. L'entreprise a signalé un retard de soumission à la FDA en raison de la fermeture du gouvernement américain et s'attend à des questions initiales de la FDA au quartier 4 2025. Le Pivot n'est actuellement pas approuvé par la FDA pour la vente.
Modular Medical (NASDAQ:MODD) hat seine nächste Pivot tubeless Insulin-Patch-Pumpe der Generation für die FDA 510(k)-Freigabe am 14. November 2025 eingereicht und rechnet mit dem kommerziellen Start im Q1 2026 nach Freigabe. Der Pivot verfügt über einen 3 ml entnehmbaren Vorratsbehälter, ein zweigeteiltes abnehmbares Design (für Duschen/Aktivitäten) und Bolus-Fähigkeit ohne separaten Controller. Die Herstellungsumstellung ist validiert und auf dem Weg zur Marktreife. Das Unternehmen wies auf eine Verzögerung der FDA-Einreichung aufgrund des US-Regierungsstillstands hin und erwartet erste Fragen der FDA im Q4 2025. Der Pivot ist derzeit noch nicht von der FDA zum Verkauf freigegeben.
Modular Medical (NASDAQ:MODD) قدمت جهاز Pivot اللاسِلكي للطرف Tubeless insulin patch pump من الجيل التالي للحصول على موافقة FDA 510(k) في 14 نوفمبر 2025 وتتوقع البدء بالطرح التجاري في الربع الأول 2026 بعد الموافقة. يتميز Pivot بخزان قابل للإزالة بسعة 3 مل، وتصميم فاصل من جزأين قابل للإزالة (للإستحمام/الأنشطة)، وقدرة Bolus بدون وحدة تحكم منفصلة. التثبيت التصنيعي تم التحقق وهو في طريقه إلى جاهزية الإطلاق. أشارت الشركة إلى تأخّر في تقديم FDA بسبب إغلاق الحكومة الأمريكية وتتوقع أسئلة FDA الأولية في الربع الرابع 2025. Pivot غير معتمد حالياً للبيع من قبل FDA.
- Targets a $3 billion "almost-pumper" market
- 3 ml removable reservoir; bolus without separate controller
- Validated production line conversion; launch-ready Q1 2026 upon clearance
- Pivot is not currently cleared for sale by the FDA
- FDA timeline impacted by U.S. government shutdown; initial questions expected Q4 2025
Insights
510(k) submission is a meaningful regulatory milestone but commercial outcomes remain contingent on clearance and execution.
Modular Medical submitted its Pivot™ tubeless patch pump for FDA 510(k) clearance and plans a commercial start in
The near-term pathway depends directly on the FDA review and any follow-up questions expected in
Watch for the FDA’s initial questions this quarter, the formal 510(k) clearance decision, and evidence the production line meets launch requirements ahead of the planned
-Targets
- Aims to Improve Patient and Clinician Experience for the Care of Diabetes
SAN DIEGO, CA / ACCESS Newswire / November 14, 2025 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company") today announced the 510(k) premarket submission of its next generation Pivot™ tubeless patch pump to the U.S. Food and Drug Administration (the "FDA"). The Company expects to commence the commercial launch of its Pivot pump in Q1 2026.
Key Investment Highlights
Feature | Impact |
|---|---|
First 2-part tubeless patch pump | 3 milliliter ("ml") removable reservoir; no battery recharge; detachable for showering/physical activity, no controller needed to bolus |
Targets | ~ |
Manufacturing on track | Validated production line conversion on track; Q1 2026 launch-ready upon clearance from FDA |
FDA timeline | Submission delayed by U.S. government shutdown; initial FDA questions expected during Q4 2025 |
"The Pivot submission is an exciting milestone in our mission to deliver a differentiated tubeless patch pump experience to those who want a simple pump to manage the treatment of diabetes," commented Jeb Besser, CEO of Modular Medical. "Our Pivot patch pump offers a 3 ml reservoir, the flexibility of removing the pump and the ability to bolus without a separate controller, all without sacrificing the accuracy, communications and clinical reporting advantages of a true electronic pump.
"Convincing a person who requires daily insulin to adopt a pump, instead of multiple daily injections, can improve the patient and clinical experience, while potentially reducing healthcare costs and improving long-term patient outcomes. We believe our two-part Pivot patch pump design, easy to learn interface and scalable manufacturing will all contribute to a differentiated user experience and represents a unique approach to this market." "On behalf of the board of directors, I would like to thank the entire Modular Medical team, and all of our stakeholders and shareholders for their support to allow us to achieve this major milestone. With the end of the U.S. government shutdown, we have now been able to submit the Pivot for 510(k) clearance to the FDA. We expect to receive initial questions from the FDA this quarter and are proceeding in parallel with the manufacturing preparation to be able to commercially launch our Pivot product upon clearance."
The Pivot insulin delivery system is not currently cleared for sale by the FDA.
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, whether the Company can obtain FDA clearance for its Pivot insulin delivery system, the timing of expected FDA clearance for its Pivot insulin delivery system; the Company's ability to convert patients to use its MODD1 pump; the occurrence of future events or circumstances, 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, 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 annual report on Form 10-K. 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.
About Modular Medical
Modular Medical, Inc. (Nasdaq: MODD) is a development-stage medical device company that intends to launch the next generation of insulin delivery technology. Using its patented technologies, the company seeks to eliminate the tradeoff between complexity and efficacy, thereby making top quality insulin delivery both affordable and simple to learn. Our mission is to improve access to the highest standard of glycemic control for people with diabetes taking it beyond "superusers" and providing "diabetes care for the rest of us."
Modular Medical was founded by Paul DiPerna, a seasoned medical device professional and microfluidics engineer. Prior to founding Modular Medical, Mr. DiPerna was the founder (in 2005) of Tandem Diabetes and invented and designed its t:slim insulin pump. More information is available at https://modular-medical.com.
Pivot is a trademark of Modular Medical. All other trademarks mentioned herein are the property of their respective owners.
CONTACT:
Jeb Besser
Chief Executive Officer
Modular Medical, Inc.
+1 (617) 399-1741
IR@modular-medical.com
SOURCE: Modular Medical, Inc.
View the original press release on ACCESS Newswire
FAQ
What did Modular Medical announce about the Pivot pump (MODD) on November 14, 2025?
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