Repro-Med Systems (OTC:REPR) said last week that the FDA cleared a 2016 warning letter for its Freedom 60 syringe infusion pump and Freedom Edge infusion pump and made some changes in the executive suite.
Repro-Med, which does business as RMS Medical Products, said the closure of the warning letter stemmed from its successful bid for 510(k) clearance for its Integrated Catch-Up Freedom Syringe Driver System, granted in September.
“We are thrilled and excited that FDA has recognized the leading edge concept of a constant pressure infusion system which must include everything in the fluid path to determine the performance consistent with the FDA’s definition of infusion pump. The final chapter of closing the warning letter confirms that FDA has found RMS to have adequately addressed all the concerns raised in the warning letter. This effort was conducted under the outstanding leadership of our chief medical officer, Dr. Fred Ma,” CEO Andy Sealfon said in prepared remarks.
RMS also said that COO Eric Bauer is slated to step down Nov. 17 for another job, but pledged to help with the transition. The company is also mounting a search to replace Sealfon after a strategic review, pending his retirement.
“Finally, in an effort to prepare the company for anticipated growth, the board of directors has committed to strengthening its membership and governance in coming months,” RMS said.