The Digital Therapeutics Evidence Gap: What FDA Authorization Actually Required
Dr. Dereck Mush, MD, MBA
Insera Therapeutics
Device company behind the CLEAR Aspiration System for peripheral clot removal.
What they do
Insera Therapeutics makes the CLEAR Aspiration System, FDA 510(k) cleared on June 24, 2026 (K253404) for removing fresh, soft emboli and thrombi from peripheral arteries and veins. The clearance was announced September 28, 2026.
The record
- Vertical
- Medical Devices
- Sub-segment
- Peripheral thrombectomy
- Product type
- Medical device
- Stage
- Private
- Headquarters
- Dallas-Fort Worth, Texas, USA
- Region
- North America
- Founded
- Not disclosed
- Total funding
- Undisclosed
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