View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
July 15, 2022

DyAnsys receives US FDA approval for First Relief neurostimulation device

First Relief is placed behind the ear and provides continuous pulses of low-level electrical current.

DyAnsys has received US Food and Drug Administration (FDA) approval for its percutaneous electrical neurostimulation (PENS) device, called First Relief, to treat diabetic neuropathic pain.

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

First Relief is intended for symptomatic relief of chronic, intractable pain related to diabetic peripheral neuropathy through multiple treatments for up to 56 days.

Placed behind the ear, the wearable device provides continuous pulses of low-level electrical current for several days.

DyAnsys CEO Srini Nageshwar said: “We are excited to have the FDA clearance of First Relief so that this device, which has been proven effective, can now be used to treat patients who have been experiencing pain related to diabetic neuropathy.

“First Relief offers a significant treatment option without drugs or narcotics.”

The regulatory approval was based on data obtained from a randomised, double-blind, single-centre, controlled prospective study, which was conducted with 63 participants aged between 30 and 74 years.

In the study, First Relief was evaluated against a placebo, as well as another device that had previously been approved by the US FDA.

The devices were applied for a period of 16 weeks on a bi-weekly basis.

Pain intensity was measured through the Visual Analog Scale (VAS) score as the study’s primary efficacy endpoint.

The insomnia severity index (ISI), vibration perception threshold (VPT) value, total neuropathy limitations scale (ONLS) and Hamilton rating scale for anxiety were measured as some of the study’s secondary endpoints.

Based on the findings from the study, subjects treated with First Relief experienced a significant reduction in VAS pain score from the start of treatment to the end, with the improvements continuing throughout 90 days of follow-up.

This suggests that the device can provide long-term improvement in neuropathic pain.

DyAnsys noted that similar improvements were also observed for all secondary endpoints, demonstrating significant improvement in sleep and mood alongside a decrease in neuropathic pain.

Related Companies

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network