INRange Systems (Altoona, Pennsylvania) has received FDA clearance of its EMMA system (for Electronic Medication Management Assistant), aimed at reducing potential drug identification and dosing mishaps.
EMMA — dubbed by INRange as “the electronic medication nurse” — is a computerized medication box to be used at home but under the supervision of a licensed provider.
The device stores prescription medications and emits an audible alert to the patient when the prescribed medications are scheduled to be taken and releases them onto a delivery tray when activated by the patient at the appropriate time. “It’s very easy to use,” Chris Bossi, president of INRange, told Biomedical Business & Technology. “To get FDA approval we had to do a usability test [for ages 25 and up].”
EMMA was named by an INRange electrical engineer as the result of a company-wide contest, with the name meaning “universal” in Latin, “mother” in Hebrew.
“My goal was to create an electronic nurse who would sort the patients medications, reorganize them when they change and deliver them to the patient,” said Mary Anne Pap, MD, a co-founder and inventor of the system, in a company statement. “EMMA is that electronic nurse. She is stationed in the home 24 hours a day, seven days a week. She ... takes no vacations.”
Cube-shaped, approximately bread-box size and plugged into a standard outlet, the device can hold up to a month’s supply of 10 prescriptions per unit. If need be, multiple units can be connected together to increase the number of managed prescriptions. It is linked wirelessly to software that allows pharmacists to remotely schedule, monitor compliance and make real-time adjustments to the dose or timing of medications from their office. Patients are alerted through an audio and visual signal when its time to take the medication.
A touch on the screen of EMMA, dispenses the correct prescription medications into a tray. The medications are loaded into the system much like a CD is loaded into a car stereo.
Based on the programmed medication schedule, EMMA removes the required number of individual doses out of the blister card and drops them onto the tray. An electronic medication administration record ensures that multiple caregivers can be alerted to a change in medication.
The company touts the device in particular for its ability to manage disease states that require multiple medications, and therefore could result in wrong medications administrations and dosages. These states include cardiac care, mental health, diabetes, oncology, organ transplants, HIV and AIDS. “We’re gearing EMMA toward those patients who have chronic illness — with complex drug regimens,” Bossi told BB&T.
Founded in 2001, INRange has received several grants since its inception, including two seed-stage financings from the Life Science Greenhouse (Philadelphia) in 2006: and then $500,000.
While EMMA suggests broad potential as the first of a variety of home-based systems for home management and oversight of healthcare delivery, Bossi said that the company is entirely focused on EMMA. “Right now this is our principle project,” he said. “This is the product we want to launch our company with.”
INRange plans pilot programs to demonstrate its effectiveness and is looking for the device to be available for commercialization in early 2008.
Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, in a statement announcing the clearance, said that the system “will help take away some of the confusion patients can experience when taking prescription medications and allow care providers to more closely monitor their patients’ medications between office visits.”