Neurology in Connecticut

Hyperfine, Inc. designs and manufactures the Swoop® system, an ultra-low-field (0.064T) portable brain MRI platform engineered for point-of-care deployment. The Swoop system delivers diagnostic-quality neuroimaging without requiring dedicated MRI infrastructure, shielded rooms, or specialized installation. Operating on standard electrical outlets with setup in minutes, the system is designed for use by trained healthcare professionals across diverse clinical settings including ICUs, emergency departments, neurology clinics, and pediatric units. The platform incorporates Optive AI™ software, which applies deep-learning-based image reconstruction to enhance clarity and reduce noise at ultra-low field strength, supporting confident clinical diagnosis across multiple pulse sequences (T1, T2, FLAIR, DWI with ADC, and variants in axial, coronal, and sagittal planes). Key design features include an open architecture to reduce patient anxiety, quieter operation compared to conventional MRI, no ionizing radiation exposure, and the ability for family members and caregivers to remain present during imaging. The Swoop system serves acute care, neurology, and pediatric populations with a focus on accessibility and rapid turnaround for time-sensitive neurological conditions. Hyperfine maintains regulatory compliance across multiple markets and provides customer support and training infrastructure for clinical implementation.

CEFALY Technology manufactures FDA-cleared wearable neuromodulation devices for the acute treatment and prevention of migraine headaches. The CEFALY device is a transcutaneous electrical nerve stimulation (TENS) system that targets supraorbital nerve pathways to reduce migraine pain and frequency without pharmaceutical intervention. The company positions its products as drug-free alternatives for migraine management, with clinical evidence demonstrating reduction in migraine days and decreased reliance on migraine medications. The device operates through two treatment modes: an ACUTE program for rapid pain relief during active migraine attacks, and a PREVENT program (20-minute daily protocol) for long-term migraine frequency reduction. CEFALY offers connected device options integrated with the CeCe Migraine Management mobile application (iOS and Android), enabling patients to track treatments, identify migraine patterns, and optimize therapy protocols. The product has been in clinical use since 2008 and is relied upon by tens of thousands of patients. The company emphasizes safety and tolerability, with no serious adverse effects reported and a 90-day money-back guarantee. Distribution is direct-to-consumer via the company website with flexible payment options including Affirm financing, PayPal Credit, and HSA/FSA eligibility. CEFALY maintains regulatory clearance through FDA approval and positions its neuromodulation technology as addressing medication overuse headache (MOH) concerns and cognitive side effects associated with traditional migraine pharmaceuticals.

BioWave Corporation manufactures FDA-cleared neuromodulation devices for non-invasive pain management and functional recovery. The company specializes in high-frequency peripheral nerve stimulation (HFPNS) technology that delivers therapeutic stimulation directly to pain nerves, blocking pain signal transmission at the source rather than masking surface pain. BioWave's product line includes portable, easy-to-use devices for clinical and home use, complemented by professional in-office procedures. Products include BioWavePRO (professional clinical system), BioWaveHOME (home-use device), BioWaveGO (portable system), BioWavePENS (in-office procedure delivering up to 72 hours of relief in a 30-minute session), and consumable electrodes (noninvasive and percutaneous). Clinical evidence demonstrates meaningful pain reduction, improved mobility and activities of daily living, reduced medication dependency, and high patient satisfaction. The technology is prescribed by the Veterans Administration for tens of thousands of veterans managing chronic and acute pain. BioWave devices are indicated for use in orthopedic, sports medicine, workers' compensation, personal injury, and auto insurance settings. The company serves patients, healthcare providers, sports medicine teams, and distribution partners. Devices are non-surgical, drug-free, and safe for continuous home use with automatic shut-off. Coverage is available through multiple insurance pathways including Workers' Compensation and Personal Injury claims.

Kelyniam Global Inc. is a US-based manufacturer of custom cranial and craniofacial implants, specializing in expedited delivery for urgent surgical cases. Founded in 2011 and headquartered in Connecticut, the company designs and manufactures custom PEEK (polyetheretherketone) implants, BCP (biphasic calcium phosphate) implants, and biocompatible synthetic materials for reconstructive neurosurgery and craniofacial procedures. The company is the only provider to consistently deliver custom cranial and craniofacial implants within 24–48 hours for RUSH and expedited cases, reducing hospital length of stay and infection risk for in-house patients. Kelyniam's proprietary Integrated Fixation System (IFS) tabs are FDA-cleared and patented, designed to eliminate or reduce the need for cranial plating, thereby decreasing overall surgical time and cost. Products include custom PEEK implants, Fusion™ BCP PEEK implants, patented IFS tabs, Osteopore® biocompatible scaffolds, and 3D-printed medical models for surgical planning. The company provides comprehensive clinical resources including CT scan protocols, Instructions for Use (IFU), and clinical data to support surgeon decision-making. All implants are manufactured in the USA and meet regulatory standards for medical device safety and precision.

The Alden Tool Company is a family-owned Connecticut manufacturer (established 1947) specializing in precision surgical cutting tools, instruments, and components for orthopedic, spinal, maxillofacial, and cranial surgery. The company manufactures drills, reamers, broaches, taps, drill guides, trocar tips, and custom surgical instruments for medical device OEMs. Manufacturing capabilities include CNC Swiss turning, 4- and 6-axis CNC milling, CNC tool and cutter grinding, OD and surface grinding, de-burring, laser marking (FDA 2D matrix compliant), and ultrasonic cleaning and passivation. Quality infrastructure includes optical comparators, CNC-controlled OGP vision systems, SPC, and full lot traceability. The company is ISO 13485 certified and FDA registered, with documented quality management systems meeting regulatory requirements. All completed orders include inspection, sterilization, autoclave qualification, and packaging. Alden Tool works directly with client engineering teams on custom projects, controlling design, manufacturing cost, timeline, and budget. The company serves multiple medical OEMs and operates a state-of-the-art facility staffed by highly skilled machinists.