Buchanan Ingersoll & Rooney Assists Client Patient Home Monitoring with FDA Licensing

Announced today in more than a dozen domestic and international media, Buchanan Ingersoll & Rooney will be advising firm client Patient Home Monitoring (PHM) – a company focused on in-home management for patients with chronic disease – on in-licensing an INR meter for home use in the United States and Canadian markets.

INR – short for international normalized ratio – is a measure of the clotting tendency of blood. Patient Home Monitoring’s services allow patients to self-test their INR levels without weekly clinic visits.

Led by FDA lawyer Ed Allera, he will assist in identifying an appropriate meter and formulating a plan for 510(k) approval required by the FDA for new medical devices. PHM estimates the project will be completed during its 2014 fiscal year.

In its release, PHM lauded Buchanan Ingersoll & Rooney’s FDA practice and its experience with medical device in-testing and approvals.

PHM plans “to license a meter with wireless technology,” which CEO Dr. Jaime Gerber believes “will yield higher accuracy and productivity from our patient base.”

“With approval, PHM can offer flexibility to patients with a selection of several self-testing devices,” she added.