Healthcare ranking
Top 10 US clinical chemistry diagnostics companies by FDA clearances 2026
Dexcom received the most FDA 510(k) clearances for clinical chemistry tests and glucose monitors of any company headquartered in the United States between 1 November 2025 and 31 October 2026, with 7 clearances. The list ranks US companies by the number of clearances assigned to the clinical chemistry review panel in that period.
Top 10 at a glance
The full list
| Rank | Company | FDA 510(k) clearances (clearances) |
|---|---|---|
| 1 | Dexcom | 7 |
| 2 | Danaher | 6 |
| 3 | BD (Becton, Dickinson and Company) | 5 |
| 4 | Beta Bionics | 4 |
| 4 | Truvian Health | 4 |
| 6 | Abbott | 2 |
| 6 | Insulet | 2 |
| 6 | Deka Research and Development | 2 |
| 6 | Nova Biomedical | 2 |
| 6 | Tandem Diabetes Care | 2 |
How this list is built
We counted FDA 510(k) clearances (substantially equivalent decisions) with a decision date from 1 November 2025 to 31 October 2026 assigned to the clinical chemistry review panel; De Novo grants are not counted. Clearances held by subsidiaries and under name variants are merged into the parent company ("Beckman Coulter, Inc." and "Radiometer Medicals Aps" are counted as Danaher), and government bodies, hospitals and universities are left out. Each company is placed in the country of its headquarters, or of its parent company after merging, so a US subsidiary of a German group counts for Germany. Companies with the same count share a rank, and all companies tied at the last place are shown.
Every position is set by the data alone, by the same rules for every company. Spotted something to update? Write to info@stratummarketresearch.com with the list and the line, and we correct it within two working days.
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Frequently asked questions
Who is number one in the US clinical chemistry diagnostics companies by FDA clearances ranking?
Dexcom ranks first with 7 clearances (1 November 2025 to 31 October 2026).
How is this ranking calculated?
We counted FDA 510(k) clearances (substantially equivalent decisions) with a decision date from 1 November 2025 to 31 October 2026 assigned to the clinical chemistry review panel; De Novo grants are not counted. Clearances held by subsidiaries and under name variants are merged into the parent company ("Beckman Coulter, Inc." and "Radiometer Medicals Aps" are counted as Danaher), and government bodies, hospitals and universities are left out. Each company is placed in the country of its headquarters, or of its parent company after merging, so a US subsidiary of a German group counts for Germany. Companies with the same count share a rank, and all companies tied at the last place are shown.
Can a company pay to rank higher?
Positions come only from the counts described above, and inclusion is free. Every company is ranked by the same rules.
How often is the ranking updated?
Every list is recomputed each quarter from the latest public records, and the update date is printed on the page.
Can a ranked company use the badge?
Yes. Every ranked company can use the free web badge on this page on its website, in press releases and on social media.
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