ASA Monitor February 2022, Vol. 86, 14.
New medical technology designed to better manage hypotension during surgery gains FDA clearance
Directed Systems Limited, a medical software and data science company based in Cambridge, U.K., recently received U.S. Food and Drug Administration 510(k) clearance for a new version of its Hypotension Decision Assist (HDA) software, HDA-OR2. This follows the initial FDA 510(k) clearance of the original HDA in November 2019.
HDA software is designed to help anesthesiologists better manage hypotension during surgery and is installed on a medical grade touch-screen tablet. HDA-OR2 is indicated to acquire, process, and display key cardiovascular characteristics of patients undergoing surgery to assist anesthesiologists in management of blood pressure, hemodynamic stability, and the cardiovascular system during surgery.
The newest version is designed for use on a smaller, lighter, more portable tablet, and enables a complete case review summary that visualizes any hypotensive episodes, total cumulative hypotension, and trends of hemodynamic parameters over the procedure. Its improved functionality also has additional networking capabilities, ability to access cloud-based analytics, and a reporting platform for in-depth analysis of individual and overall caseload metrics.
FDA authorizes marketing for new virtual reality chronic pain reduction system
In November 2021, the FDA authorized the marketing of EaseVRx. This prescription-based virtual reality (VR) system, which is manufactured by AppliedVR, combines cognitive behavioral therapy with other behavioral methods to help reduce chronic lower back pain in patients age 18 years or older.
EaseVRx is designed for at-home self-use. Patients use a VR headset and controller. The headset is equipped with a “Breathing Amplifier” that directs a user’s breath toward the headset’s microphone for use in deep breathing exercises.
The device leads users through an eight-week, skills-based treatment program, which includes activities such as deep relaxation, attention-shifting, interoceptive awareness, perspective-taking, distraction, and more. Users interact with a series of VR sessions that are between two and 16 minutes long.
Chronic lower back pain includes moderate to severe lower back pain that has persisted for more than three months; it is one of the most common chronic pain conditions in the nation. Patients with chronic pain may benefit from EaseVRx’s cognitive behavioral therapy used along with other currently available treatments, such as prescription and over-the-counter medications, exercise, steroid injections, surgery, and transcutaneous electrical nerve stimulation.