StimWave wins FDA nod for Apple iOS-based WaveCrest mobile SCS patient controller

Stimwave said yesterday it won FDA 510(k) clearance for an Apple (NSDQ:AAPL) iOS device version of its WaveCrest Mobile platform patient controller application for pain management.

The newly cleared system from the Pompano Beach, Fla.-based company allows patients with iPhone and Apple Watch devices to control WaveMaster multi-waveform automated programming for the company’s Wireless Freedom spinal cord stimulator system intended to treat chronic pain.

“Patients’ needs in pain management are unique and customized programming is a must. The Freedom System not only is the smallest option available for patients eliminating the complexities of an implanted lithium ion battery, but offers a wide variety of advanced programming features that the patient can choose through their mobile device. WaveCrest Mobile provides patients with a high-tech approach to controlling their pain through their mobile device and future features and upgradeability options they never had before,” Dr. Ellen Lin of the San Antonio, Texas-based Advanced Spine and Pain Center said in a press release.

The system allows the user to adjust their pain relief therapy, and is the first FDA-cleared device that allows the Apple Watch control of implanted neuromodulation devices, Stimwave said.

“Pain suffers are rapidly migrating to the Stimwave Freedom wireless pain relief system as an opioid free option to control their pain- and now they can adjust their therapy with the swipe of their finger through their Apple Watch or iPhone/iPod Touch discretely any time as needed. Transformation of pain treatment moving from opioids and pills to interventional solutions like Stimwave can only happen as a result of empowering the masses to take control of their pain, which is now as easy as 1-2-3 with WaveCrest Mobile,” Stimwave chair & CEO Laura Perryman said in a prepared statement.

In January, StimWave said that it raised more than $50 million from a consortium of unnamed investors for the consumer launch of its Freedom neuromodulation device for treating chronic pain.

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