Wearable Therapeutics: A Healthcare Revolution. Will the Tonic Motor Activation (TOMAC) System developed by Noctrix provide a possible solution?

• The Food and Drug Administration, U.S., has approved a wearable technology that can help activate or stimulate muscles in a sustained or continuous manner.
• Electrodes placed on the skin tend to produce electrical impulses through these devices that can stimulate muscle contractions and promote muscular activation.

Growth Plus Reports | May 19th, 2023

On April 19th, 2023, Noctrix Health?has announced the successful completion of a randomized controlled trial (RCT) and the FDA's approval of their Breakthrough Tonic Motor Activation (TOMAC) Restless Legs Syndrome (RLS) Therapy. The FDA has approved Noctrix Health's De Novo request for the?NTX100 Tonic Motor Activation (TOMAC) System?for the treatment of symptoms of moderate-severe RLS and to enhance the sleep quality in patients who are not responding to medicines.

About the?NTX100 Tonic Motor Activation (TOMAC) System

The NTX100 ToMAc is a non-invasive system comprised of two distinguished therapy units and two separate electrode patches worn below the knees to provide high-frequency, low-level electrical stimulation to the peroneal nerves, which supply movement and sensation to the lower legs, feet, and toes. The patient can utilize a basic user interface on the treatment devices to start or stop the stimulation, alter the intensity, or view the battery status. Using a Clinician App, the prescribing clinician may tune therapeutic output for each patient. The Clinician App is only utilized in the clinic by the clinician.

What is the latest update from Food and Drug Administration, U.S.??

The latest news was taken from FDA Roundup: April 18, 2023:

The FDA approved the NTX100 Tonic Motor Activation (NTX100 ToMAc) System for the treatment of primary moderate-to-severe Restless Legs Syndrome (RLS) and to enhance sleep quality in drug-resistant RLS patients.

In May 2020, the FDA granted this treatment "Breakthrough Device Designation." To suppress RLS symptoms, a pair of devices worn on the lower legs electrically excite the peroneal nerves bilaterally to induce tonic, a persistent muscular activity that is compatible with sleep and suppresses symptoms of RLS.

About Noctrix Health?

Noctrix Health is at the forefront of the next generation of therapeutic wearables, empowering patients to take control of their chronic medical issues. Noctrix intends to offer a potent, effective, and cost-efficient alternative to pharmaceutical therapy.

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Source:

1)?????Noctrix Health announces successful randomized controlled trial (RCT) outcomes and FDA Marketing Authorization for its Breakthrough Tonic Motor Activation (TOMAC) Restless Legs Syndrome (RLS) Therapy (prnewswire.com)

2)?????FDA Roundup: April 18, 2023 | FDA