- Accelerate Diagnostics Inc (NASDAQ:AXDX) said that according to recent discussions, the FDA has clarified that the company must obtain a 510(k) clearance to continue marketing and distributing the Accelerate Arc Products in the U.S.
- Accelerate Arc Products include Accelerate Arc system and related BC Kit.
- The company had been listing the Accelerate Arc Products as a Class I device exempt from 510(k) clearance requirements.
- The company intends to continue fully cooperating with the FDA, promptly taking the corrective actions requested by the FDA.
- Accelerate Diagnostics also submitted a pre-submission package to the FDA, which is intended to obtain FDA feedback regarding the company’s contemplated submission of an application for 510(k) clearance for Accelerate Arc Products.
- The company cannot, however, give any assurances that FDA will be satisfied with the company’s actions taken in response to the matters raised by the FDA in its discussions. It also cannot give any assurances as to the timing of the FDA’s response.
- Accelerate Diagnostics will continue marketing and distributing the Accelerate Arc Products in Europe under its existing CE In Vitro Diagnostic Regulation (IVDR) registration.
- Price Action: AXDX shares are down 42.7% at $0.91 on the last check Monday.
Phio Pharmaceuticals Announces $2M Registered Direct Offering Of 353,983 Shares Of Common Stock At Price Of $5.65/Share At-The-Market Under Nasdaq Rules
Phio Pharmaceuticals Corp. (NASDAQ:PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today
