ERT Receives 510(k) Clearance to Market Its AM3® GSM Devices for Use in Respiratory Clinical Trials

News provided by

ERT

Jun 17, 2014, 08:30 ET


Philadelphia, PA (PRWEB) June 17, 2014 -- ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its AM3® GSM devices in respiratory clinical trials. The AM3 GSM device provides a robust and reliable wireless option for clinical trial patients to communicate key spirometry data during the clinical development of new respiratory treatments.

Upon completion of a patient session, the AM3 GSM automatically sends and receives data using secure SMS text messages utilizing the global GSM M2M network. Because GSM M2M offers wide international roaming capabilities, this solution offers a very cost-effective method for routine data transfers. An analog modem solution via ERT’s VIAConnect® is also available for patients without wireless coverage.

ERT’s AM3 device measures and saves all relevant expiratory flow-volume parameters, such as PEF and FEV1, and records events, medication, and symptoms — including standardized assessments like the ACQ for asthma trials and EXACT-PRO for COPD — delivering a complete electronic diary for home monitoring.

Achim Schuelke, Executive Vice President and Respiratory Product Line Executive at ERT stated, “Now with the availability of AM3 GSM, these important respiratory data can be simply and cost-effectively transferred from a patient’s home which allows near real-time access to patient data for investigators and sponsors, enabling better patient monitoring and, ultimately, better care.”

With nearly 80,000 AM3 devices used solely in worldwide clinical trials since 2009, ERT has the proven respiratory experience that sponsors can trust. To learn more about ERT’s centralized respiratory services and for more information on ERT’s enhancements to the AM3 family of devices, visit http://www.ert.com/respiratory.

About ERT
ERT (http://www.ert.com) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized cardiac safety, respiratory services, suicide risk assessment and Clinical Outcome Assessments (COAs) – which includes patient, clinician, and observer reported outcomes. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes, and delivers safety and efficacy data critical to the approval, labeling, and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.

Christine Tobin, ERT, http://www.ert.com/, +1 (412) 719-4568, [email protected]