Cleared
Certified
& MDR
Manufacturing
The video laryngoscope in the USA has become standard practice across the operating rooms, emergency departments, intensive care units, and prehospital settings. Driven by clinical evidence, updated ASA Difficult Airway Algorithm guidelines, and a shift toward improved first-pass intubation success rates, US hospitals are actively evaluating and upgrading their airway management systems.
AstraVue provides a complete video laryngoscope system in the USA with full FDA clearance, ISO 13485 certification, and a blade range covering neonatal through adult difficult airway cases. This page is a reference for US clinicians evaluating systems, procurement teams requiring regulatory documentation, and distribution partners seeking to bring AstraVue into the US market.
Reusable Devices
Disposable Devices
Mini Monitors
Accessories
The Lite system combines a reusable camera handle with disposable blade attachments, delivering cost-effective infection control for surgical centers and hospital wards managing high patient throughput without the full cost of an all-disposable system.
Ideal for high-volume US emergency departments and ICUs where infection control is paramount. The Pro Blade is a fully disposable unit, including the integrated camera, eliminating reprocessing costs and cross-contamination risk entirely. Available in Macintosh, Miller, and hyperangulated configurations.
AstraVue is backed by Goldstar Medical’s 40+ year manufacturing legacy and holds full FDA clearance, CE marking, MDR compliance, and ISO 13485 certification. Our complete video laryngoscope system is designed to integrate seamlessly into existing US hospital protocols, with no proprietary lock-in.
For institutions with established reprocessing workflows, the Ultra Blade offers surgical-grade stainless steel construction designed for long-term, high-volume use. Fully autoclavable and built to withstand the demands of busy US operating rooms.
All AstraVue blade systems connect to a single universal 4-inch HD touchscreen monitor — with 120 minutes of battery life and mini-HDMI output for connection to larger displays in teaching hospitals and simulation centers.
The ASA Difficult Airway Algorithm and Society for Airway Management (SAM) guidelines both recognise video laryngoscopy as a recommended approach for anticipated and unanticipated difficult airways. In emergency medicine, ACEP guidance similarly acknowledges its role in improving intubation outcomes in high-acuity settings.
Video laryngoscopes use an integrated blade-tip camera connected to an external monitor, allowing indirect visualisation of the glottis without requiring direct line-of-sight alignment. This is particularly valuable in patients with limited neck mobility, obesity, trauma, or anatomical variations that restrict conventional direct laryngoscopy.
AstraVue blades are available in three configurations designed for different clinical environments:
Pro blades: fully disposable single-use units, including the integrated camera. Suited to emergency departments and ICUs where infection control and speed are priorities.
Lite blades: reusable camera handle with disposable blade attachments. A cost-effective hybrid option for high-throughput wards and surgical centers.
Ultra blades: surgical-grade stainless steel, fully reusable and autoclavable. Designed for operating rooms with established reprocessing workflows.
All three configurations connect to a single universal 4-inch HD touchscreen monitor with mini-HDMI output for connection to larger displays during clinical teaching or case review.
The AstraVue range spans from neonatal through adult hyperangulated configurations, designed to cover the full spectrum of patient populations encountered in US hospital practice. Full blade size specifications are available on request from the AstraVue team.
Any Video laryngoscopes in the USA are classified as Class II medical devices in the United States and require FDA 510(k) clearance prior to commercial distribution. AstraVue devices hold full FDA clearance. US hospital supply chain teams, value analysis committees, and GPO or IDN procurement processes can request complete regulatory documentation directly from AstraVue or its authorized US distribution partners.
In addition to FDA clearance, AstraVue devices carry:
Full certification documentation, device specifications, and 510(k) clearance details are available on request for procurement evaluation processes.
AstraVue’s universal monitor platform works across all blade types and sizes, reducing capital outlay and simplifying staff training compared with systems requiring separate monitors per blade category. Procurement teams can configure a single system to serve the OR, ED, ICU, and pediatric departments simultaneously.
We are seeking qualified medical device distributors with established relationships in US hospitals, surgical centers, and emergency services, and with experience handling Class II airway management or critical care devices.
The ASA Difficult Airway Algorithm and Society for Airway Management (SAM) guidelines both recognise video laryngoscopy as a recommended approach for anticipated and unanticipated difficult airways. In emergency medicine, ACEP guidance similarly acknowledges its role in improving intubation outcomes in high-acuity settings.
Video laryngoscopes use an integrated blade-tip camera connected to an external monitor, allowing indirect visualisation of the glottis without requiring direct line-of-sight alignment. This is particularly valuable in patients with limited neck mobility, obesity, trauma, or anatomical variations that restrict conventional direct laryngoscopy.
To discuss distribution partnership opportunities, request regulatory documentation, arrange a product demo, or obtain pricing for US procurement:
Email: sales@astra-vue.com
Phone: +971 54 406 9599
Website: astra-vue.com/contact-us
AstraVue responds to all US distribution and procurement inquiries within one business day.
Our global network of authorized distributors provides comprehensive support to healthcare professionals. For product inquiries, contact your local distributor. For distribution opportunities and partnership inquiries, contact us directly.
Yes. AstraVue video laryngoscopes in the USA hold FDA 510(k) clearance and meet all US requirements for commercial distribution and clinical use. Full clearance documentation is available on request.
Our products meet global standards including FDA, CE, MDR, and ISO 13485 certifications, ensuring compliance with international healthcare regulations.
If we have stock available, delivery can be made within 1 week. If stock is not available, lead times may extend up to 20 weeks (approximately 5 months)
The AstraVue range spans neonatal through adult hyperangulated configurations. Full size specifications are available directly from the AstraVue team on request.
The Pro blade is fully disposable including the integrated camera, requiring no reprocessing. The Lite system uses a reusable camera handle with disposable blade attachments, reducing per-use cost while maintaining single-use infection control for the patient-contact components. For more details, read this blog.
Yes. AstraVue is actively expanding its authorized US distribution network. We are seeking qualified partners with established hospital and surgical center relationships and experience in Class II medical device distribution. Market exclusivity is available in defined territories. Contact sales@astra-vue.com to begin a conversation.
Yes. The AstraVue universal monitor includes mini-HDMI output, allowing connection to larger bedside or wall-mounted displays for resident training, simulation, and case review sessions.
The monitor provides 120 minutes of continuous operation and is compatible with all AstraVue blade configurations, including Pro, Lite, and Ultra across all size variants.
