Pediatrics in Colorado

Tortle Product LLC manufactures FDA-cleared Class I medical devices designed to prevent and correct positional plagiocephaly (flat head syndrome) and torticollis in infants. Founded by pediatrician Dr. Jane Scott, the company offers a suite of corrective beanies for both outpatient and hospital use. The flagship Tortle Air corrective beanie is a soft, snug device that gently encourages infants to reposition their heads, reducing flat spots and promoting balanced neck muscle development. The company also manufactures in-hospital products including the Tortle Midliner and Tortle Midliner MAX, designed for neonatal intensive care units (NICUs) and compatible with respiratory devices. These products support nursing and therapy protocols in hospital settings. Tortle beanies are available in multiple sizes (Small, Medium, Large) and designs. The FDA clearance distinguishes Tortle devices from unsafe head-shaping pillows, which the FDA warned against in November 2022. Tortle products are HSA and FSA eligible, making them accessible to families seeking non-invasive preventive and corrective care. The devices address two prevalent infant medical issues: positional head flattening affecting approximately 50% of U.S. infants by three months, and torticollis, which can require costly physical therapy if untreated. Tortle's products serve both outpatient families and hospital NICU environments, providing an evidence-based alternative to physical therapy and surgical interventions.

Securisyn Medical develops innovative airway management and securement devices designed to enhance airway safety, prevent unplanned extubation, and reduce associated clinical complications. The company's core focus is on endotracheal tube stabilization solutions for both adult and pediatric populations, including neonatal applications. Their flagship product, SolidAIRity® Flex, targets adult airway securement with applications across ICU, operating room, and field trauma environments. Securisyn's approach emphasizes patient safety, practitioner confidence, and healthcare cost reduction through evidence-based device design and clinical validation. The company is committed to sustainable, ethical business practices while advancing ventilator safety standards and airway management protocols across acute care settings.

Ultrasound AI is a healthcare technology company founded in 2019 that develops AI-powered software tools for maternal and neonatal healthcare. The company's flagship product, Delivery Date AI™, uses artificial intelligence trained on over 8 million ultrasound images to accurately predict delivery dates in singleton pregnancies (14–36 weeks gestation) where a reliable estimated delivery date is unavailable. Delivery Date AI™ received FDA De Novo authorization in 2026 and is currently approved for clinical use in the United States, Brazil, and Chile. The company also developed Preterm AI™, designed to identify risks of preterm birth and enable proactive clinical interventions. Ultrasound AI holds six issued patents across three countries and positions its solutions as decision-support tools that augment clinician judgment in obstetric care, addressing the critical clinical need for accurate pregnancy dating to improve maternal and neonatal outcomes.

TheraTogs manufactures wearable therapeutic garment systems designed to provide dynamic postural support and alignment correction for children and adults with neuromuscular and developmental disorders. The product line includes adjustable, strappable garments (tank tops, hipsters, full suits) in multiple sizes (infant through adult) that deliver continuous proprioceptive input and external support to improve trunk stability, postural control, and functional movement patterns. Indicated for cerebral palsy (all types), developmental delay, Down syndrome, autism spectrum disorder, brain injury, stroke, ataxia, hypotonia, spina bifida, and various orthopedic/postural conditions. Garments are washable, customizable with strapping configurations, and designed for extended daily wear (up to 10 hours reported). Clinical evidence includes case reports demonstrating improvements in gait mechanics, upper extremity control, balance, independence in ambulation, and functional activities when worn during therapy and home carryover. The company maintains a professional account system for therapists and distributors, offers educational materials and videos, and operates an international distribution network. Products are designed to work in conjunction with standard therapy modalities and other assistive devices. All garments meet safety and material standards for pediatric and adult medical wear.

Genesee BioMedical is a Denver-based cardiac surgery device manufacturer specializing in minimally invasive and open cardiac surgical instruments. The company designs and manufactures annuloplasty rings and bands for mitral and tricuspid valve repair, cardiac surgery retractors for adult, pediatric, and neonatal procedures, coronary graft markers (silicone and stainless steel), and the ART-2 Aortic Toolkit for valve replacement and repair. Products are engineered for open, port-access, and robotic-assisted cardiac procedures. The TransForm™ McCarthy Mitral Annuloplasty Ring is a flagship semi-rigid device that adapts from D to O shape for valve repair. All retractors feature curved frames designed to follow thoracic contours and low-profile options for minimally invasive access. The company positions itself as surgeon-driven, with products developed collaboratively with cardiac surgical teams. Manufacturing capabilities include precision machining and assembly of surgical-grade instruments using stainless steel and silicone materials. The firm serves adult cardiac surgery, pediatric cardiac surgery, and neonatal cardiac care markets. Regulatory pathway and FDA status not explicitly stated on site. Company is located in Denver, Colorado.

OSYPKA is a multinational medical device manufacturer with over 45 years of experience specializing in interventional cardiology and pediatric cardiology solutions. The company develops and manufactures active implants and catheters for cardiac applications, including pacemaker electrodes and radiofrequency ablation systems. OSYPKA operates as both a branded product manufacturer and a contract development and manufacturing organization (CDMO) serving global medical device partners with turnkey solutions for implantable devices and catheters. The company pioneered the first fracture-resistant implantable pacemaker electrode and has developed innovative technologies in cardiac intervention and neurostimulation. OSYPKA maintains manufacturing and quality capabilities across three main locations: Germany (headquarters in Rheinfelden), the USA (Longmont, Colorado), and the Czech Republic (Odry). The organization holds ISO 13485:2016 certification, EU Quality Management System certification under MDR (Medical Device Regulation), and Czech Quality Management System certification. The company serves interventional cardiologists, hospital systems, and medical device OEMs worldwide with both proprietary product lines and custom manufacturing solutions.

ASI Medical, Inc. manufactures specialized dental operatory equipment and mobile dental delivery systems for modern treatment rooms. The company designs and produces a comprehensive line of dental delivery carts, including the Advanced Dental Systems®, Advanced Endodontic Systems®, Triton Series portable systems, Implant & Surgical delivery systems, and Orthodontic & Pediatric delivery carts. All systems feature modular, custom-configurable designs with integrated instrument consolidation (high-speed handpieces, endodontic motors, implant motors, ultrasonic systems, obturation and curing lights) controlled via single foot pedal operation. ASI specializes in space-efficient, minimalist dental office designs that reduce clutter and patient anxiety while improving operator ergonomics. The company offers both traditional rear delivery systems and self-contained portable carts; the Triton Series features internal air compressors, vacuum systems, and clean water supply requiring only standard electrical outlet connection—eliminating need for specialized plumbing. All dental delivery carts include self-contained water supply with one year of water line treatment disinfection. ASI manufactures equipment locally in the U.S., enabling superior design and quality control. The company provides architectural design consultation, treatment room planning services, and ergonomic seating solutions through its Momentum brand. Equipment installation is contractor-friendly with simplified utility connections via junction boxes; portable models require no installation. ASI serves dentists in general practice, endodontics, implant surgery, orthodontics, and pediatric specialties. The company operates a support and parts division (ASIsupport.com) and maintains a showroom facility in Englewood, Colorado.

Certa Dose (operated by CD Acquisitions, LLC) is a medical safety company focused on eliminating dosing errors, particularly in emergency and pediatric settings. The company develops innovative dosing solutions centered on visual verification and cognitive offloading to prevent medication administration errors. Their core mission addresses a critical patient safety gap: studies indicate that 70% of dosing errors occur during drug administration and are missed by electronic ordering systems, with pediatric patients facing 3x higher error risk than adults. The company's primary product offering is the Certa Dose app—a digital solution that enables healthcare providers to visualize the correct medication volume, select appropriate syringes, and document dosing procedures. The app supports weight-based dosing calculations for patients of varying ages and sizes, allowing clinicians to enter actual patient weight or estimate it using length or age parameters when exact measurements are unavailable. The platform employs color-coded confirmation systems and visual verification protocols to enhance accuracy and communication clarity among care teams. Physical product offerings include the PALS (Pediatric Advanced Life Support) Syringe Holder Kit, designed specifically for pediatric emergency codes, and an Epinephrine Convenience Kit for anaphylaxis management across the neonatal-to-adult dosing spectrum. The company also manufactures a pediatric measuring tape for weight estimation during emergencies. These products are positioned as essential tools for emergency departments, pediatric units, and critical care environments where dosing accuracy directly impacts patient survival.

EvoEndo is a specialized medical device manufacturer focused on sedation-free endoscopy solutions for pediatric and adult gastroenterology. The company develops ultra-thin, single-use endoscopes designed for both transnasal and transoral procedures, eliminating the need for anesthesia while maintaining diagnostic and therapeutic capability. The EvoEndo System comprises ultra-slim flexible scopes with four-way steering, a portable high-definition controller, and virtual reality-based patient distraction technology. FDA-cleared for visualization and treatment of the upper digestive tract (esophagus, stomach, duodenal bulb), the system is available in 85 cm (pediatric) and 110 cm (adult/pediatric) configurations. By removing anesthesia and associated risks, the platform reduces procedure costs, recovery time, and complications—particularly beneficial for pediatric patients requiring multiple endoscopies. EvoEndo is recognized as the only medical device firm dedicated exclusively to pediatric gastroenterology care and aligns its innovations with current clinical guidelines.

Youth Crews manufactures specialized incontinence products designed for children and young people aged 4–17 who have outgrown standard baby diapers but are not suited to adult products. The company offers three purpose-built sizes (9, 10, 11) engineered specifically for youth body dimensions and developmental needs. Products feature adaptive design with tab-based fastening for dignity and independence, high-capacity absorbency to prevent leaks, soft materials for comfort, and age-appropriate, non-clinical aesthetics. Founded by a parent seeking better solutions for his disabled daughter, Youth Crews addresses a significant market gap in pediatric incontinence care. Products are FSA/HSA eligible, available through direct-to-consumer e-commerce with subscription and one-time purchase options, and backed by strong customer ratings (5 stars, 350+ family reviews).