Devices

De Novo Granted for Virtual Reality for Pain

FDA has authorized the de novo marketing of AppliedVR’s EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain. EaseVRx uses cognitive behavioral therapy CBT and other behavioral therapy techniques to reduce pain and pain interference. It comprises a VR headset and a controller, along with a “breathing amplifier” attached to the headset that directs a patient’s breath toward the headset’s microphone for use in deep breathing exercises.

The device’s VR program uses behavioral therapy to address the physiological symptoms of pain and aid in pain relief through a “skills-based treatment program,” the company says. “These principles include deep relaxation, attention-shifting, interoceptive awareness — the ability to identify, access, understand and respond appropriately to the patterns of internal signals — and perspective-taking, distraction, immersive enjoyment, self-compassion, healthy movement, acceptance, visualization, knowledge of pain and rehabilitation.” The treatment program involves 56 VR sessions that are 2-16 minutes in length as part of a daily eight-week treatment, it says.

An FDA release says the marketing authorization was based on data from a randomized, double-blinded clinical study of 179 patients with chronic lower back pain who were assigned to one of two eight-week VR programs: the EaseVRx immersive 3-D program or a control 2-D program that did not utilize skills-based CBT methods. “At the end of treatment, 66% of EaseVRx participants reported a greater than 30% reduction in pain, compared to 41% of control participants who reported a greater than 30% reduction in pain. Furthermore, 46% of EaseVRx participants reported a greater than 50% reduction in pain compared to 26% of control participants.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome