International Regulatory HurdlesHealth Canada has issued a denial for the company’s marketing authorization, and the company plans to file for reconsideration pending the outcome of the FDA review.
Regulatory ChallengesThe company received a denial letter from the FDA regarding the 510(k) de novo application for the use of DrugSorb-ATR during coronary artery bypass grafting surgery.
Regulatory UncertaintyThe company has not disclosed the specific issues with the regulatory filings, making it difficult to evaluate whether a resolution could be reached, leading to skepticism about the appeal's success.