Deymed Diagnostic

Deymed Diagnostic is a manufacturing company that provides neurological medical devices with software solutions and neurofeedback services.

Deymed Diagnostic s.r.o. is a Czech company that manufactures and distributes medical devices for neurofeedback and brain monitoring applications. Its key product offerings include BrainFeedback Pro, TruScan LT, and DuoMAG NL.

Deymed Diagnostic s.r.o. - 671076 - 11/07/2023

Transforming neurological care with innovation

Neurostimulation Tech

Deymed Diagnostic s.r.o. is a Czech company that manufactures and distributes medical devices for neurofeedback and brain monitoring applications. Its key product offerings include BrainFeedback Pro, TruScan LT, and DuoMAG NL.
The BrainFeedback Pro is a Class II non-sterile device intended for diagnosing and monitoring brain conditions. It utilizes neurofeedback technology to measure and provide feedback on brain activity. However, as of October 2023, Deymed discontinued the sale of this device in the US due to non-compliance with FDA regulations.
The TruScan LT is another Class II non-sterile neurofeedback device manufactured by Deymed. It consists of multiple printed circuit boards (PCBs) assembled using automated pick and place machines. This device is used for neurofeedback applications, but as of November 2023, Deymed was still working on establishing adequate manufacturing procedures for its PCBs.
Deymed also contract manufactures the DuoMAG NL, a Class II non-sterile device, for an undisclosed client.
In November 2023, the FDA issued a warning letter to Deymed citing multiple violations of the Quality System Regulation, including lack of design controls, inadequate complaint handling procedures, deficient production processes, and incomplete device history records. The company was in the process of addressing these issues at that time.

Aleva Neurotherapeutics is a medical device company specializing in deep brain stimulation (DBS) systems for treating neurological disorders such as Parkinson's disease and essential tremor. Based in Lausanne, Switzerland, the company was founded as a spin-off from the Swiss Federal Institute of Technology. Aleva pioneered the development of directional DBS leads with its flagship product, the directSTIM DBS system. This technology aims to deliver more precise electrical stimulation to targeted areas of the brain, potentially improving therapeutic benefits and reducing side effects compared to traditional omnidirectional DBS leads.
The directSTIM system features a novel 12-electrode lead design based on microelectromechanical systems (MEMS) technology. This allows for smoother electrode surfaces and customized shapes optimized for implantation in the brain. The system also incorporates 24 independent current sources, enabling greater flexibility in programming and personalizing stimulation patterns to each patient's unique needs. In May 2024, Aleva received CE marking for the directSTIM system, allowing its commercial launch in Europe.
Aleva's expertise in DBS technology is reflected in its robust intellectual property portfolio, comprising 13 patent families and 90 granted patents related to DBS for neurological and psychiatric disorders. The company aims to transform DBS therapy by combining advanced technologies with shared clinical data to improve surgical experiences and patient outcomes.

Aleva Neurotherapeutics

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The company has developed Deep Transcranial Magnetic Stimulation (Deep TMS), a proprietary technology that uses magnetic pulses through a patented H-coil helmet to stimulate deeper and broader brain regions associated with various conditions.
Deep TMS received FDA clearance for treating major depressive disorder (MDD) in 2013, making BrainsWay the first and only TMS company with clinical evidence demonstrating efficacy for this indication. In 2018, the technology obtained FDA clearance for treating obsessive-compulsive disorder (OCD), and in 2021, it was cleared as an aid for short-term smoking cessation.
The Deep TMS treatment is administered through a series of daily sessions over four to six weeks, with each session lasting around 20 minutes. It has been investigated in over 30 randomized clinical trials worldwide, demonstrating its safety and effectiveness. As of April 2021, BrainsWay announced that 100,000 patients have been treated globally with Deep TMS.
In addition to the FDA-cleared indications, BrainsWay is conducting ongoing or planned clinical trials exploring Deep TMS for various psychiatric, neurological, and addiction disorders. The company's commitment to clinical research and building upon its substantial body of evidence positions it as a leader in advancing neuroscience through non-invasive solutions.

Brainsway

Cala Health is a bioelectronic medicine company that has developed the Cala kIQ system, a wearable neuromodulation device that delivers transcutaneous afferent patterned stimulation (TAPS) therapy for the relief of hand tremors in adults with essential tremor and Parkinson's disease. The Cala kIQ system comprises a stimulator, a band with integrated electrodes, and a base station. It utilizes a calibrated TAPS output pattern adjusted to match the patient's unique tremor frequency, providing personalized stimulation to the median and radial nerves of the wrist.
The Cala kIQ system received 510k clearance from the US Food and Drug Administration (FDA) in November 2022 and was launched for human use in June 2023. The device offers treatment sessions of 40 minutes, with a wristband life of 90 days and a shelf life of three months. Patients can review their therapy session results through the MyCala.com patient portal and share them with healthcare providers.
Cala Health has reported positive clinical data demonstrating the effectiveness of TAPS therapy in reducing tremors and improving activities of daily living for essential tremor patients. The company has secured reimbursement and coding from various commercial and government payors, including Medicare, to improve patient access to the therapy.

Cala Health

Cardionomic is a medical device company based in Minneapolis that has developed the Cardiac Pulmonary Nerve Stimulation (CPNS) System, an investigational device designed to treat patients suffering from acute decompensated heart failure (ADHF). The CPNS System consists of a stimulation console and an endovascular catheter that delivers targeted stimulation to the cardiac plexus located in the right pulmonary artery.
The company's approach is founded on the principle that stimulating the autonomic nerves improves a patient's clinical condition by triggering a rebalancing of the autonomic system, shifting it from an imbalanced state into a cycle that enhances the patient's condition even after the therapy is completed. The CPNS System has demonstrated the ability to increase cardiac contractility without significantly affecting heart rate in heart failure patients with reduced ejection fraction.
In January 2024, Cardionomic announced the completion of enrollment in the STIM-ADHF and STOP-ADHF pilot studies, which evaluated the safety and performance of the CPNS System in treating ADHF patients. A total of 35 patients were treated across seven countries. Preliminary results suggest that the CPNS therapy may address the unmet need for more effective treatment options for hospitalized heart failure patients. The pooled data from these studies is planned for publication in early 2024.
The CPNS System leverages engineered electrode surfaces from Pulse Technologies, Inc. to deliver durable electrochemical performance for the neural and cardiac interfacing applications.

Cardionomic

Charco Neurotech was founded in 2019 by Lucy Jung, an industrial designer who was inspired to develop assistive devices for Parkinson's after her own experience as a patient. The CUE1 is a small plastic disc with an electric motor that vibrates at a high frequency in a specialized pattern. This pattern, proven through research, can disrupt the overactive brainwaves that cause Parkinson's symptoms, allowing for improved movement.
The CUE1 attaches to the user's sternum using medical adhesive and is relatively inexpensive compared to other treatments like deep brain stimulation implants. Over 2,000 people in the UK are currently using the CUE1, with a waiting list of almost 20,000 across 120 countries as of March 2024. Charco has raised over USD 10 million in funding and grants, employing around 38 people across the UK, South Korea, and the US.
The device is accompanied by a smartphone app that enables users to personalize the stimulation settings and track their symptoms. Charco aims to obtain regulatory approvals for the CUE1 to be prescribed through healthcare systems like the NHS. In April 2023, Addenbrooke's Hospital in Cambridge became the first hospital to trial the device on inpatients with Parkinson's.
Key customers and partnerships
As of August 2023, over 1,700 people are benefiting from the CUE1 in the UK, and there is a waiting list of over 17,000 people worldwide. Charco has partnered with Dr. Alistair Mackett, a consultant geriatrician at Cambridge University Hospitals, to conduct trials and research on the device's effectiveness.

Charco Neurotech

Companies that offer solutions for pain management, neuropathies, and related disorders and migraines.

Companies that provide solutions for Parkinson's disease, epilepsy, and speech and movement disorders.

Companies that offer treatments for depression, Alzheimer's, and other mental health-related disorders.

Companies that offer solutions for heart-related medical issues such as acute decompensated heart failure and high blood pressure.

Companies that offer solutions for urinary or fecal incontinence, autoimmune diseases and other functional impairments

Companies that offer solutions for hearing or vision impairment, sleep-related conditions, and other disorders, including obesity treatments.

Deymed Diagnostic

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