JelikaLite is a clinical-stage medical technology company developing wearable neuromodulation devices for developmental pediatric disorders, led by Cognilum, a photobiomodulation system being studied for autism. Its approach combines near-infrared light, sensors and machine-learning personalization in a home-based device intended to support communication and social responsiveness. The company has received FDA Breakthrough Device Designation and Non-Significant Risk Device Study Designation for Cognilum, which remains under development and has not been approved by the FDA for autism.
FDA Breakthrough Device Designation
Compliance program
FDA Non-Significant Risk Device Study Designation
Compliance program
TecTraum IncTecTraum Inc. develops pro2cool®, an investigational medical device that delivers localized cooling to the head and neck as a potential treatment for concussion. Founded when professional athletes joined engineers to address the lack of concussion therapies, the company has studied the system through a multi-center clinical trial involving pediatric hospitals and high school athletes in Ohio and Michigan. The device received FDA Breakthrough Device designation in June 2021 but has not received FDA market authorization.AKRON, OH
Crosby Tech CorporationCrosby Tech Corporation is the company behind BuddyBand, a small wearable tracker designed for caregivers of people with autism, dementia, and other special needs. Built alongside the Champion Autism Network, the company pairs the device with a service that helps families monitor a loved one’s location and receive SOS notifications.BROOKLYN, NY
BiliBabyBiliBaby is developing an at-home newborn monitor that measures bilirubin during the first 14 days of life, giving parents and clinicians a noninvasive alternative to repeated blood draws. The system sends readings to healthcare providers through Bluetooth and a mobile app, with the goal of helping families keep up with jaundice checks when travel to a clinic is difficult. Its product remains under development and is not yet for sale in the United States.
SunPowerLED (Kerber USA Inc.)Founded by Tom Kerber, SunPowerLED is the light-therapy operation of Kerber USA Inc., developing photobiomodulation equipment for home users, healthcare professionals, and university researchers. The Amherst company is known for engineering its devices around active cooling and spectroradiometer-verified light output, with its transcranial PBM helmet tied to a published, IRB-approved university study.AMHERST, NY