aScope Gastro

by Ambu  · Based in Denmark → — Single-Use Gastroscope for Efficient and Sterile Endoscopic Procedures
Gastroenterology General Surgery
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Overview

The Ambu® aScope™ Gastro is a sterile, single-use gastroscope designed for a variety of endoscopic procedures in the upper GI tract. It offers advanced imaging and design features, providing a portable solution that eliminates the need for reprocessing. The aScope Gastro, when combined with the Ambu® aBox™ 2 display and processing unit, delivers high-definition imaging and an intuitive user interface. This system aims to streamline workflow, reduce the risk of cross-contamination, and provide consistent quality and performance for every patient. It is suitable for use in various care settings, including endoscopy units, operating rooms, intensive care units, emergency rooms, and ambulatory surgery centers. Ambu also offers the aScope™ Gastro Large, which is the world’s first therapeutic single-use gastroscope with a 4.2 mm working channel, designed for procedures requiring superior suction and access to a wider range of tools. The aScope Gastro Large also features a handle made with bioplastics, contributing to sustainability efforts.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Sterile and single-use
  • Advanced HD imaging and design features
  • Portable display unit (aBox 2) with touchscreen
  • Eliminates reprocessing and associated risks of cross-contamination
  • Consistent quality, feel, and performance
  • 210u00b0 retroflexion and 120u00b0 downward angulation
  • 2.8mm working channel (aScope Gastro)
  • 4.2mm working channel (aScope Gastro Large) for superior suction
  • Dual LEDs and 140u00b0 field of view
  • Bioplastic handle (aScope Gastro Large)

Use Cases

  • Diagnostic and therapeutic procedures in the upper GI tract
  • Esophagogastroduodenoscopy (EGD)
  • Acute upper gastrointestinal bleeding (UGIB)
  • Direct endoscopic necrosectomy (DEN)
  • Stricture management
  • Removal of foreign bodies and food impaction
  • Intraoperative endoscopy (bariatric, foregut, thoracic, general, trauma surgeries)

What Physicians Need to Know

Real-Time Endoscopy AI
The aScope Gastro connects to the Ambuu00ae aBoxu2122 2, a display and processing unit with a built-in touchscreen HD LCD monitor that provides live endoscopic HD capabilities and excellent image quality. The intuitive user interface is placed next to the endoscopic image on the screen, making it easy to retain focus and control. The aBox 2 allows surgical teams to zoom in and out of camera views, record video, take photos, and adjust display settings with a simple tap.
Endoscopy System Compatibility
The aScope Gastro is a sterile, single-use flexible gastroscope intended for use with a compatible Ambu displaying unit (aBox 2) and a variety of endotherapy accessories and other ancillary equipment. It is compatible with most commonly available medical suction and insufflation/rinsing fluid management systems, standard suction tubes, medical grade CO2 insufflators, endoscopic irrigation/flushing pumps, and high-frequency electrosurgical equipment.
Procedure Documentation
The aBox 2's intuitive touchscreen controls facilitate smooth documentation, allowing surgical teams to record video and take photos during procedures.
Quality Metrics Tracking
As a single-use device, the aScope Gastro ensures consistent quality, feel, and performance for every procedure, eliminating the deterioration in mechanical performance that can occur with reusable endoscopes after repeated reprocessing. This consistency can contribute to more reliable procedural outcomes.
Physician Tip

Leverage the aScope Gastro's single-use nature for urgent and unscheduled procedures, as it's always available and sterile, reducing turnaround times and eliminating reprocessing concerns. Utilize the 210u00b0 retroflexion and 140u00b0 field of view for comprehensive visualization, especially in difficult-to-reach areas of the upper GI tract. The aScope Gastro Large, with its 4.2 mm working channel, offers superior suction capabilities, which can be particularly beneficial in critical cases like acute upper GI bleeding. The lightweight design may also contribute to reduced endoscopist fatigue during longer procedures.

The aScope Gastro seamlessly integrates with the Ambuu00ae aBoxu2122 2 display and processing unit, which serves as the central hub for imaging and control. It is designed to be compatible with standard accessory devices and tube sets, as well as various ancillary equipment such as medical suction, CO2 insufflators, and electrosurgical units.

Details

Category Gastroenterology AI, Surgical AI
Pricing Contact for pricing
  • Ambu aScope Gastro Endoscope (Box of 6): $12,900.00; Ambu aScope Gastro Large Endoscope (Box of 6): $11,990.55
DeploymentOn-premise (device-based)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated

The Ambu aScope Gastro and Ambu aBox 2 received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) in February 2022. The aScope Gastro Large also received 510(k) clearance from the FDA in April 2024.
Integrations
EHR Not specified
Specialties Gastroenterology, General Surgery

What the Web Says

The Ambu aScope Gastro is a single-use gastroscope that has garnered positive feedback from physicians for its clinical acceptability and performance. It is seen as a viable alternative to reusable gastroscopes, particularly due to its sterile nature, which eliminates cross-contamination risks and improves workflow efficiency. The device has been successfully used in a wide range of EGD indications, including diagnostic and therapeutic procedures.

Overall: Positive

Strengths

  • Eliminates risk of patient infection and cross-contamination due to its single-use, sterile design.
  • Improves workflow and efficiency by removing the need for reprocessing, repairs, and associated downtime.
  • High clinical acceptability (97%) and procedure completion rate (95%).
  • Excellent maneuverability and visualization, with 99% of physicians finding the field of view met or exceeded expectations.
  • Superior suctioning ability and articulation performance compared to reusable gastroscopes.
  • Lighter weight than reusable scopes, potentially reducing physician fatigue.

Limitations

  • Picture quality was deemed inferior in some cases compared to reusable scopes.
  • Some feedback included the absence of a freeze button and lens cleaning issues.
  • Duodenal intubation proved more challenging in a percentage of EGDs.
  • Potential environmental concerns regarding the disposal of single-use devices, though Ambu is working on bio-plastic alternatives.
  • Initial cost of the system (aBox 2) can be significant.

Based on reviews from: Ambu, PubMed Central, HFMA, Medi-Tech Insights, Lippincott, ISPOR, Facebook, Gut

Last updated: 2026-08-07

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Press & Coverage

Via Ritzau
AMBU OBTAINS FDA CLEARANCE FOR WORLD'S FIRST SINGLE-USE THERAPEUTIC GASTROSCOPE
Ambu announced 510(k) regulatory clearance from the U.S. FDA for its therapeutic gastroscope solution, Ambu aScopeu2122 Gastro Large and Ambu aBoxu2122 2, expanding its single-use portfolio for upper GI procedures. The aScopeu2122 Gastro Large is the first single-use therapeutic gastroscope with a 4.2 mm working channel and the world's first endoscope made with bioplastics.
2024-04
Gastroenterology & Endoscopy News
FDA Clears Larger Disposable Scope Made With Bioplastics
The FDA granted 510(k) clearance to the aScope Gastro Large (Ambu), a larger single-use scope that incorporates recycled materials in its construction. This marks a significant step in sustainable endoscopy.
2024-05
Scope Forward
Single-Use Therapeutic Gastroscope Obtains FDA Clearance (Single- Use Endoscopy)
Ambu received FDA clearance for aScope Gastro Large, the world's first single-use therapeutic gastroscope with a 4.2mm working channel, expanding its portfolio for upper GI procedures and addressing diverse clinical needs. The device is designed for acute therapeutic procedures and is made with bioplastic materials to reduce its carbon footprint.
2024-04
Ambu Press Release
Ambu announces FDA clearance of single-use gastroscope and next-generation display unit
Ambu announced 510(k) regulatory clearance of the Ambuu00ae aScopeu2122 Gastro and Ambuu00ae aBoxu2122 2 in the United States, marking Ambu's entry into the gastroscopy segment with its first sterile single-use gastroscope featuring advanced imaging and design. This solution aims to address limitations of reusable endoscopes, including cross-contamination risks and efficiency in various care settings.
2022-02
FierceBiotech
Ambu scores FDA clearance for single-use gastroscope and touchscreen display
Ambu received FDA clearance for its single-use gastroscope, aScope Gastro, and the aBox 2, a real-time imaging unit with a touchscreen display. This clearance allows Ambu to enter the gastroscopy market, offering a lightweight, sterile, and cost-effective alternative to reusable endoscopes.
2022-02
G-MedTech
Ambu Receives CE Mark for aScopeu2122 Gastro Large with 4.2mm Working Channel
Ambu announced European regulatory clearance (CE mark) for its aScopeu2122 Gastro Large and aBoxu2122 2 in September 2023, expanding its gastroenterology offering with a larger-sized gastroscopy solution. This device is also notable for being the world's first endoscope made with bioplastics.
2023-09
Endoscopy International Open (via PMC)
Performance of a single-use gastroscope for esophagogastroduodenoscopy: Prospective evaluation
This prospective observational study evaluated the performance of the CE-certified single-use Ambu aScope Gastro for esophagogastroduodenoscopy (EGD) in adult patients. The study found a 96.7% successful completion rate for EGDs using the aScope Gastro, with overall satisfaction rated as comparable to reusable scopes in most cases, despite some drawbacks in image quality.
unknown
Gut
Environmental impact of single-use versus reusable gastroscopes
A life cycle assessment comparing the environmental impact of single-use (Ambu aScope Gastro) and reusable gastroscopes found that single-use gastroscopes have a 2.5 times higher carbon footprint per examination. The study, conducted from April 2023 to February 2024, provides data to aid in the logistics and planning of endoscopic services.
2024-10

Videos

Product demos, reviews, and walkthroughs for aScope Gastro.

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Frequently Asked Questions

aScope Gastro is designed for seamless integration with standard endoscopy towers, utilizing its own display and control unit. Its AI capabilities focus on real-time image enhancement and potentially flagging areas of interest, though specific diagnostic AI features and their regulatory status should be clarified with Ambu.
aScope Gastro, like all medical devices with AI, must adhere to stringent regulatory standards such as FDA clearance in the US and CE marking in Europe. Physicians should verify the specific regulatory approvals for any AI-driven diagnostic or assistive features, as these can vary.
While aScope Gastro offers a single-use solution, alternatives include traditional reusable endoscopes and other single-use devices from competitors. Comparison should focus on image quality, maneuverability, specific AI functionalities (if any), and the overall cost-effectiveness considering reprocessing expenses for reusable scopes versus the per-procedure cost of single-use devices.
The AI in aScope Gastro is primarily designed to enhance visualization. While it may aid in highlighting areas, its role in definitive detection and characterization of subtle mucosal changes or early neoplastic lesions would depend on its specific algorithms and regulatory claims. Physicians should always rely on their clinical judgment.
The long-term cost implications involve comparing the per-procedure cost of aScope Gastro against the initial capital expenditure, reprocessing costs, and repair expenses of reusable endoscopes. Additionally, inquire about any potential subscription models for AI software updates or advanced features, as these can influence the total cost of ownership.
Like all AI systems, aScope Gastro's AI may have limitations in challenging scenarios such as significant bleeding, excessive mucus, or highly irregular anatomy. Understanding these limitations is crucial for physicians to interpret AI-generated insights appropriately and avoid over-reliance in complex cases.
Data privacy and security are paramount. Physicians should inquire about aScope Gastro's compliance with HIPAA and GDPR regulations, including how patient-specific endoscopic images are processed, stored, and transmitted, and what safeguards are in place to prevent data breaches.

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Suggest an Edit → | Last Verified: 2026-08-05 | First Added: 2026-08-05
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