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Roche, Abbott, Siemens, Others Get 510(k) Clearance in August
◆ Sectors
Medtech
◆ Geography
United States
◆ Source
◆ Verified
Fusion42 · 17 September 2026 · Fusion42 review
The US FDA granted 510(k) clearance in August to more than a dozen in vitro diagnostic tests from major companies including Roche, Abbott, Siemens, Qiagen, Cepheid, Aptitude Medical Systems, and Leica Biosystems.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
Your medtech product can enter or compete in the US market more easily now that FDA clearances are advancing for key diagnostics. Track competitors gaining clearance closely and accelerate your own regulatory plans.
◆ Coverage
1 source · 17 Sep 2026
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Medtechfda-clearancein-vitro-diagnosticsmedtech510kregulatory-update