1. Roche in 30 seconds, and where it stands in biosensors

2. The logo and how the name is written

3. Where the company sits in the field

4. Scale

Roche has two divisions, Pharmaceuticals and Diagnostics; this profile concerns Diagnostics. The Group as a whole is shown only briefly Sourced.

"Core operating profit" is Roche's own measure, which excludes items such as restructuring costs and amortization of intangible assets. For the lower core operating profit, the company points to the growing installed base of instruments, manufacturing ramp-up costs for new products (notably the Accu-Chek SmartGuide), U.S. tariffs and healthcare pricing reforms in China Sourced.

In the first half of 2026 (January to June), Diagnostics sales were CHF 6,735 million (+3% at CER, -3% in CHF), and Near Patient Care was CHF 909 million (-5% at CER, -11% in CHF). The company attributes the decline mainly to a shorter respiratory-illness season that reduced molecular point-of-care sales, and says higher demand for blood glucose monitoring products partly offset it Sourced.

5. Resources committed to biosensors

Roche reports at the division level (Diagnostics). There are no figures for headcount, R&D or capital spending limited to biosensors (glucose testing and continuous monitoring). The table shows what could be confirmed.

Regulatory status (as far as could be confirmed)

An FDA "510(k) clearance" recognizes substantial equivalence to a device already on the market. It is different from "De Novo authorization", which is used for novel devices, and from "PMA approval".

6. What it has done so far

7. What comes next

Everything below is a company plan or target, not something already achieved. It is based on the Diagnostics Day 2025 materials (20 May 2025), an official release, and the dates planned in ClinicalTrials.gov Not yet confirmed.

• U.S. launch: A May 2025 company slide notes that SmartGuide is not sold in the U.S. and that a 510(k) submission was pending with the FDA. A search of the FDA 510(k) database by applicant name and product code, run by us on 3 October 2026, did not find a Roche continuous glucose monitor. A company statement on the current status or expected timing of the submission could not be confirmed.
• Clinical studies: NCT06704672 has a planned enrollment of 270, an expected primary completion of 15 November 2026 and an expected overall completion of 30 May 2027. NCT07814508 is expected to complete on 31 October 2026.
• Financial targets: The same materials give a medium- to long-term ambition of mid- to high-single-digit sales growth for Diagnostics, and expected low- to mid-single-digit growth for 2025. These are division-wide targets, not targets for continuous monitoring.

8. What the company is aiming for in biosensors

This chapter separates what the company says directly from what we have read into its materials. Inference marks our interpretation of primary sources.

9. Map of partnerships in biosensors

The only relationships in Roche's materials where the counterparty can be named are acquisitions Sourced. The FDA document for the Accu-Chek Solo micropump says it can communicate with compatible digitally connected devices, including automated insulin dosing software, but does not name them. The suppliers of SmartGuide sensor components (electrodes, enzymes, membranes, battery) and any contract manufacturers are likewise not named in the materials we reviewed Not yet confirmed.

10. Technologies, products and services

The Diagnostics Division's products run from central-laboratory analyzers (cobas, Elecsys and others) to point-of-care testing. This profile keeps to what counts as biosensors. Performance figures are manufacturer's stated values from the instructions for use or FDA review documents; they must be read together with the reference method, population and conditions, and values from different studies cannot be lined up to rank products.

Performance values in the SmartGuide instructions for use (manufacturer's stated values)

MARD (mean absolute relative difference) is the average of the relative gaps between sensor values and comparator values (here, fingertip blood measurements); a smaller figure means closer agreement with the comparator. Values from studies with different comparison methods, participants, glucose manipulation and wear sites cannot be compared directly. The instructions for use state that interstitial glucose may not match blood glucose (especially during rapid rises or falls), that values should be used for therapy decisions such as insulin dosing only after the calibration the app requests, and that the sensor is not for critically ill patients or patients on dialysis Sourced. This article is not guidance on reading measurements or on using the product.

11. The risks this company carries

12. Glossary

13. References

1. Roche Finance Report 2025. Diagnostics Division sales, profit and sales by customer area; R&D; capital spending; acquisitions and goodwill (Medingo, mySugr, LumiraDx); subsidiary list; listing information. https://assets.roche.com/f/176343/x/fca190f63e/fb25e.pdf
2. Roche Annual Report 2025. Diagnostics business review, SmartGuide expansion and mySugr integration, employees by division. https://assets.roche.com/f/176343/x/fa3c863601/ar25e.pdf
3. Roche Half-Year Report 2026. First-half 2026 Diagnostics sales, Near Patient Care, R&D and cost of sales. https://assets.roche.com/f/176343/x/8a0b362d66/hy26e.pdf
4. Roche Diagnostics Day 2025 presentation (20 May 2025). SmartGuide roadmap, U.S. status note, financial ambition, composition of Near Patient Care. https://assets.roche.com/f/176343/x/7656180b53/diagnostics-day-20-05-2025.pdf
5. Roche Media & Investor Release, "Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution" (9 July 2024). https://assets.roche.com/f/176343/caf466c9d0/09072024_mr_accu-chek-smartguide-cgm-solution_en.pdf
6. Roche Diagnostics Media Release, "Roche announces $550 million investment to expand its Indianapolis diagnostics manufacturing hub" (12 May 2025). https://diagnostics.roche.com/content/dam/diagnostics/us/en/news-releases/pdf/indianapolis-investment-press%20release-051225.pdf
7. Roche Diabetes Care User's Manual, Accu-Chek SmartGuide device (September 2025 edition). Intended use, limitations, technical data, performance data, manufacturer. https://tools.accu-chek.com/documents/dms/en/smartguide_device_manual/smartguide_device_app_manual_en_2025-09.pdf
8. FDA 510(k) K252323, cobas pulse blood glucose monitoring system (clearance letter and 510(k) summary, 12 June 2026). https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252323.pdf
9. FDA 510(k) K160944, Accu-Chek Guide Blood Glucose Monitoring System (31 August 2016). https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160944.pdf
10. FDA 510(k) K181131, Accu-Chek Guide Me Blood Glucose Monitoring System (13 December 2018). Comparison table of strip enzyme and measurement principle. https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181131.pdf
11. FDA 510(k) K213131, Accu-Chek Guide Solo diabetes manager blood glucose monitoring system (10 August 2023). https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213131.pdf
12. FDA 510(k) K213134, Accu-Chek Solo micropump system with interoperable technology (10 August 2023). https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213134.pdf
13. FDA 510(k) K253188, CoaguChek XS Plus System (24 October 2025, Special 510(k)). https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253188.pdf
14. FDA Medical Device Recalls: Class 2 Device Recall Roche Diabetes Care, Inc., AccuChek Guide Meter (Z-2174-2024). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=207936
15. FDA (openFDA) 510(k) K944459, ACCU-CHEK INSTANT PLUS G-C/DM (Boehringer Mannheim Corp., 17 April 1996), database record. https://api.fda.gov/device/510k.json?search=k_number:K944459
16. FDA (openFDA) 510(k) K930454, BOEHRINGER MANNHEIM COAGUCHEK SYSTEM (5 August 1993), database record. https://api.fda.gov/device/510k.json?search=k_number:K930454
17. FDA (openFDA) 510(k) K150910, ACCU-CHEK Connect Diabetes Management App (3 June 2015), database record. https://api.fda.gov/device/510k.json?search=k_number:K150910
18. FDA (openFDA) 510(k) K220272, cobas pulse blood glucose monitoring system (26 April 2024), database record. https://api.fda.gov/device/510k.json?search=k_number:K220272
19. ClinicalTrials.gov NCT06704672: Accu-Chek SmartGuide CGM compared with self-monitoring of blood glucose (led by Hoffmann-La Roche; recruiting). https://clinicaltrials.gov/study/NCT06704672
20. ClinicalTrials.gov NCT07814508: Effect of the Accu-Chek SmartGuide CGM and Predict App on person-reported outcomes and behavior (led by FIDAM RDC with Roche Diabetes Care as collaborator; recruiting). https://clinicaltrials.gov/study/NCT07814508
21. Roche Official website (source of the logo image). https://www.roche.com/
22. Mader JK et al. "1924-LB: Clinical Performance of a Novel CGM System," Diabetes 2024; 73 (Supplement_1) (poster abstract at ADA 2024, cited in the official release). https://doi.org/10.2337/db24-1924-LB
23. FDA 510(k) Premarket Notification Database (search page; searched by applicant name and product code on 3 October 2026). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
24. FDA (openFDA) Device Recall database, records for Roche Diabetes Care (search result). https://api.fda.gov/device/recall.json?search=recalling_firm:%22Roche+Diabetes+Care%22&limit=30

14. Claim-to-source audit

Last updated: 3 October 2026 / Troy Technical
The figures in this article come from Roche's financial documents, official releases and instructions for use, FDA public documents and ClinicalTrials.gov. Market-research estimates and press-report figures are not used (market-size figures in Roche's own materials are not adopted). Passages marked "Inference" are our own readings of primary sources and are not statements by the company. This article does not recommend any product, and it is not guidance on reading measurements or on treatment.