RMS Receives FDA Clearance for 510(k)
RMS Freedom Infusion System Cleared for Both Subcutaneous and Intravenous Indications
CHESTER, NY / ACCESSWIRE / September 5, 2017 / Repro Med Systems, Inc. dba RMS Medical Products (OTCQX: REPR) announces the FDA issued a new 510(k) clearance for the RMS "Integrated Catch-Up Freedom Syringe Driver Infusion System" effective August 31, 2017. The Freedom System is the first and only fully integrated mechanical system cleared by the FDA for a wide range of medications and flow rates.
Manufactured in the U.S.A., the System is cleared for subcutaneous and intravenous indications, including specific subcutaneous immunoglobulins and antibiotics. The Freedom System reduces the need for stocking other specialty infusion devices for these different applications.
Andy Sealfon, RMS CEO, says, "RMS continues to provide the highest quality devices intended to improve patient quality of life. Our System delivers an accurate flow rate, and considers everything in the fluid path as an entire infusion system, making the patient the only variable. In doing so, it leads to increased compliance, healthier patients and therefore, lower overall costs. RMS will continue to develop new devices and technologies upon this platform and will be filing additional FDA 510(k) submissions for new applications in a continuing effort to help patients throughout the world."
RMS Chief Medical Officer, Dr. Fred Ma adds, "Drug infusion delivery has two critical concerns: one is patient safety (i.e. for immunoglobulins-pain, swelling, leakage, and redness) and the other is the ultimate therapeutic outcome related to the drug's efficacy. The best delivery system includes dynamic equilibrium, DynEQ™ - a mechanism that reacts to the patient site pressures and appropriately adjusts flow rate to minimize risks of over-infusion."
RMS Medical Products is the leading manufacturer of medical devices used for home infusions and suctioning. The infusion product portfolio currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, RMS Precision Flow Rate Tubing™ and RMS HIgH-Flo Subcutaneous Safety Needle Sets™. These devices are used for infusions administered in professional healthcare settings as well as at home. The Company's RES-Q-VAC® line of medical suctioning devices is used by emergency medical service providers in addition to a variety of other healthcare providers. The Company's website may be visited at www.rmsmedicalproducts.com.
This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes," "belief," "expects," "intends," "anticipates," "will," or "plans" to be uncertain and forward looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the company's reports and registration statements filed with the Securities and Exchange Commission.
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SOURCE: Repro Med Systems, Inc.
Released September 5, 2017