Check-Cap Announces FDA Conditional Approval of IDE to Initiate U.S. Pilot Study of C-Scan®
Check-Cap Ltd. - Ordinary Share (CHEK)
Last check-cap ltd. - ordinary share earnings: 11/6 08:30 am
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US:NASDAQ Investor Relations:
ir.check-cap.com
Company Research
Source: PR Newswire
ISFIYA, Israel, Dec. 13, 2018 /PRNewswire/ --Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK) (NASDAQ: CHEKW), (NASDAQ: CHEKZ), a clinical-stage medical diagnostics company offering C-Scan®, the first and only preparation free capsule-based screening method for the prevention of colorectal cancer through the detection of precancerous polyps, today announced that the U.S. Food and Drug Administration (FDA) has conditionally approved the Company's Investigational Device Exemption (IDE) application to initiate a U.S. pilot study of the C-Scan® system. The FDA's conditional approval of the IDE requires Check-Cap to provide additional information to the FDA and Check-Cap may begin enrolling patients immediately upon approval by the study site's Institutional Review Board (IRB).Alex Ovadia, chief executive officer of Check-Cap, stated: "We are pleased to have received FDA approval of our IDE application, and we look forward to initiating our pilot study of the C-Scan® system
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- Check-Cap Ltd. (NASDAQ: CHEK) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Check-Cap Ltd. (NASDAQ: CHEK) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
CHEK
Sec Filings
- 4/15/24 - Form 6-K
- 4/10/24 - Form 6-K/A
- 4/8/24 - Form SC
- CHEK's page on the SEC website