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Given Imaging

Given Imaging Ltd. was an medical technology company founded in 1998, specializing in the development and commercialization of non-invasive diagnostic imaging systems for the gastrointestinal () tract. The company's flagship product, the PillCam system—a swallowable, wireless video capsule designed to visualize abnormalities in the and other GI areas—received U.S. FDA clearance in 2001 and revolutionized minimally invasive diagnostics for conditions like and obscure GI bleeding. By 2009, Given Imaging had produced its one millionth PillCam capsule, establishing itself as a global leader in GI visualization technologies with a broad portfolio including systems for the , colon, and monitoring. Originally based on imaging technology adapted from military patents, Given Imaging operated from Yoqneam, , and expanded internationally with direct sales in key markets like the U.S. and , achieving $4.7 million in revenue from its initial product launch in . The company went public on in , raising funds to fuel growth in its Given Diagnostic Imaging System, which included disposable capsules, data recorders, and proprietary software for image analysis. In February 2014, Given Imaging was acquired by plc for $860 million, enhancing Covidien's offerings. Covidien itself was subsequently acquired by in January 2015 in a $42.9 billion deal, integrating Given Imaging's innovations into Medtronic's broader GI solutions portfolio under the PillCam brand. Today, these technologies continue to support clinical evaluations worldwide, with ongoing advancements in for comprehensive GI tract assessment.

History

Founding and Early Development

Given Imaging was founded in 1998 in Yokneam, , by Gavriel Iddan, a retired senior engineer from , who drew inspiration from electro-optical technologies he had developed for guided missile systems during his military career. Iddan, along with co-founders including Gavriel Meron and support from Rafael Development Corporation and Elron Electronic Industries, aimed to adapt these compact, principles for non-invasive medical diagnostics, specifically targeting the visualization of the . This innovation addressed a longstanding challenge in , where traditional struggled to access the entire small bowel without invasive procedures. The startup's early operations were bolstered by initial funding from its founding partners, enabling the assembly of a small R&D team focused on prototyping a swallowable capsule . Between 1998 and 2001, Given Imaging secured government grants totaling $1.2 million from Israel's Office of the Chief Scientist at the Ministry of Industry and Trade, which supported the development of the core technology and required future royalty repayments on commercial sales. These resources facilitated rapid progress, culminating in the creation of the M2A prototype—a vitamin-sized device equipped with a miniature camera, light source, and battery capable of transmitting images wirelessly as it traversed the digestive tract. Key milestones in early development included the first human trial of the wireless capsule endoscope in 1999, conducted in with gastroenterologist Paul Swain as the volunteer subject, who successfully swallowed the device to capture images of the small bowel without complications. This proof-of-concept validated the technology's feasibility and safety, paving the way for further clinical testing. In August 2001, the U.S. granted 510(k) clearance for the M2A capsule as a diagnostic tool for small bowel evaluation, marking a pivotal regulatory achievement. To scale commercialization, Given Imaging launched an on in October 2001 under the ticker GIVN, raising approximately $60 million through the sale of 5 million shares at $12 each—the first U.S. IPO by an Israeli company following the . These proceeds were earmarked for manufacturing expansion, clinical trials, and global market entry, transitioning the company from R&D to a commercial medtech enterprise.

Key Milestones and Product Launches

Given Imaging launched its flagship product, the M2A capsule (later rebranded as PillCam SB), in 2001 following FDA clearance for small bowel imaging, marking the introduction of wireless to clinical practice. This innovation rapidly gained adoption in for diagnosing obscure and other small bowel disorders, with over one million capsules utilized worldwide by 2009 to evaluate patients for various GI conditions. In 2004, the company expanded its portfolio with FDA approval for the PillCam ESO capsule, designed for esophageal visualization to aid in detecting abnormalities such as Barrett's esophagus and esophageal varices. This approval built on the PillCam SB's success, enabling non-invasive upper GI assessment and further establishing capsule endoscopy as a patient-friendly alternative to traditional endoscopy. Subsequent developments included the PillCam COLON capsule, which received CE Mark approval in Europe in 2006 for colonic imaging. An advanced version, PillCam COLON 2, obtained CE Mark in 2009 and was commercially launched in Europe shortly thereafter, offering dual cameras for improved polyp detection. In the United States, FDA clearance for PillCam COLON 2 came in 2014, positioning it as a tool for patients with incomplete colonoscopies. The product lineup continued to evolve with the introduction of PillCam Express in 2010, a delivery device for placing capsules endoscopically in patients unable to swallow them or with delayed gastric emptying; however, it was discontinued following a 2012 recall due to deployment failures. In 2016, the PillCam Crohn's capsule received CE Mark approval for combined small bowel and colonic visualization in patients, with FDA clearance following in 2017. Given Imaging also collaborated with international societies, contributing to the development of clinical guidelines for integrating colon capsule endoscopy into practice, as presented at events like United European Gastroenterology Week in 2011. By 2019, enhancements to the PillCam platform incorporated AI-assisted image analysis for improved lesion detection, further advancing diagnostic accuracy in small bowel evaluation.

Acquisitions by Given Imaging

In December 2008, Given Imaging acquired the pH monitoring business from for $20 million, gaining access to a , catheter-free pH testing system designed for diagnosing (). This acquisition marked Given Imaging's initial expansion into non-imaging gastrointestinal diagnostics, complementing its core offerings by addressing acid reflux monitoring needs in clinical practice. In March 2010, Given Imaging signed a definitive agreement to acquire Scientific Instruments, a provider of high-resolution manometry systems for esophageal assessment, for $35 million in cash, with the deal completing in April 2010. Scientific, which had generated approximately $18 million in unaudited revenues in 2009, specialized in advanced diagnostic tools for evaluating disorders and esophageal function, allowing Given Imaging to broaden its portfolio in functional testing. The purchase from Water Street Healthcare Partners strengthened Given Imaging's position in the growing market for diagnostics. In October 2012, Given Imaging acquired the assets of SmartPill Corporation, a developer of motility capsules for measuring whole-gut time, for $6 million plus potential earn-out payments based on future sales. The SmartPill system provided non-invasive assessment of gastric emptying, small bowel , and colonic , enhancing Given Imaging's capabilities in comprehensive GI motility evaluation. This deal was expected to contribute low single-digit millions in U.S. dollars to revenues starting in 2013, supporting further market penetration in patient-friendly diagnostic technologies. These acquisitions diversified Given Imaging's offerings from visual imaging to functional diagnostics, with growth in the period largely attributable to such strategic purchases, including the integration. The moves positioned the company as a more comprehensive provider in GI diagnostics, contributing to double-digit annual increases in the GI sector prior to 2014.

Acquisition by Covidien and Medtronic Integration

In December 2013, plc announced its agreement to acquire Given Imaging Ltd. for $30 per share in cash, totaling approximately $860 million net of cash and short-term investments, with the transaction completed on February 27, 2014, converting Given into a wholly owned and taking it private. This acquisition enabled to expand into the approximately $3 billion global gastrointestinal () diagnostics market, where Given's non-invasive technologies complemented 's existing surgical and monitoring tools, enhancing its comprehensive GI solutions portfolio. Following 's integration of Given, plc announced in June 2014 its intent to acquire Covidien for $42.9 billion in cash and stock—valued at around $50 billion including debt—and completed the merger on January 26, 2015, forming a new entity headquartered in , . As part of this larger transaction, Given Imaging's operations were rebranded and incorporated into Medtronic's GI Solutions business unit, aligning its diagnostic technologies with Medtronic's broader and minimally invasive therapy offerings. Post-integration, Given's research and development activities continued at its facilities in Yoqneam, , supporting ongoing innovation in GI diagnostics as a distinct unit within . In 2025, the U.S. issued a Class 1 recall and early alert for 's Bravo calibration-free (CF) pH capsule delivery devices due to misapplied adhesive potentially causing deployment failures, such as improper attachment to the or retention on the delivery device, linked to 33 serious injuries including esophageal tears. No major divestitures of Given's assets have occurred, and the PillCam capsule systems remain a core component of 's GI portfolio.

Technology

Capsule Endoscopy Technology

Capsule endoscopy technology developed by Given Imaging revolves around an ingestible, disposable device designed for non-invasive visualization of the , particularly the small bowel. The core component is a small capsule, measuring approximately 11 mm in diameter and 26 mm in length, containing a miniaturized camera, white light-emitting diodes (LEDs) for illumination, a , and a transmitter. Once swallowed, the capsule is propelled naturally through the digestive system by peristaltic contractions, capturing high-resolution color images at an adaptive rate of 2 to 6 frames per second, depending on the capsule's speed to optimize tissue coverage and battery efficiency. The captured images are transmitted wirelessly via RF signals to an external data recorder worn by the patient on a belt, which stores the video data for later processing. This recorder interfaces with , such as PillCam software version 9, that compiles the images into a video study lasting 8 to 12 hours, corresponding to the typical small bowel transit time and battery duration. The software enables physicians to review and analyze the footage efficiently, highlighting key segments for diagnostic purposes, with recent integrations including cloud-based reading platforms for remote analysis as of 2025. Key innovations in this technology include an adaptive mechanism that adjusts image capture dynamically to the capsule's , ensuring comprehensive visualization without excessive data overload, and a providing a 156-degree for broader mucosal coverage. Color imaging capabilities deliver natural tissue representation, aiding in the identification of abnormalities like or . More recently, integration of () in the analysis software, such as the TOP100 tool in PillCam systems and features in PillCam QuickView, enhances lesion detection; for instance, algorithms have demonstrated over 90% sensitivity in identifying ulcers associated with as of 2025. In December 2024, launched the PillCam Genius SB kit, the latest iteration featuring improved resolution and enhancements for small bowel visualization. Clinically, this technology offers significant advantages as a non-invasive to traditional wired , eliminating the need for or and thereby reducing associated risks such as respiratory complications or procedural discomfort. It allows patients to resume normal activities during the examination, improving tolerability for obscure or small bowel evaluation. However, limitations include the passive, one-way transit reliant on , which may result in incomplete visualization in up to 16% of cases due to delayed passage or retention, and the finite battery life that restricts examination duration.

pH and Motility Diagnostic Technology

The and diagnostic technologies developed or acquired by Given Imaging focus on non-invasive or minimally invasive methods to assess gastrointestinal physiological functions, such as acid exposure and contractile activity, through wireless sensors and pressure mapping. These systems enable extended monitoring of esophageal and gut parameters, aiding in the diagnosis of disorders like () and motility impairments without the limitations of traditional transnasal catheters. The pH monitoring system employs a , attachable capsule delivered via a transoral and secured to the esophageal wall, typically 6 cm above the gastroesophageal junction. This capsule contains an pH that transmits data radiotelemetrically to an external for up to 96 hours, allowing patients greater mobility and reducing discomfort compared to conventional 24-hour catheter-based probes; however, in June 2025, Medtronic recalled the Bravo CF capsule delivery device due to malfunctions linked to 33 serious injuries, including and . The system is FDA-cleared for gastroesophageal pH and gastric monitoring in adults and pediatric patients over 4 years old, with a pH below 4 indicating episodes. For whole-gut motility assessment, the SmartPill wireless motility capsule integrates pH, pressure, and temperature sensors within an ingestible, non-digestible device approximately 26 mm x 11 mm in size. As it traverses the , the capsule records regional transit times—gastric emptying (normally 2-5 hours), small bowel transit (2-6 hours), and colonic transit (10-59 hours)—with total gut transit under 72 hours considered normal in healthy adults. These metrics help evaluate delayed emptying or , and the system received FDA clearance for assessing gastric emptying in suspected and colonic transit in chronic . Motility patterns, such as migrating motor complexes (cyclic interdigestive contractions occurring every 90-120 minutes), are inferred from pressure changes, distinguishing normal peristaltic activity from disordered propulsion. High-resolution esophageal manometry, advanced through Given Imaging's acquisition of Scientific Instruments, utilizes the ManoScan ESO system with a solid-state featuring 36 circumferential sensors spaced 1 cm apart for detailed pressure topography mapping. This setup captures intraluminal pressures during , generating spatiotemporal plots to analyze esophageal body motility and lower esophageal sphincter function, integrated with for automated swallow classification per the Chicago Classification criteria. The technology is particularly valuable for detecting abnormalities like achalasia or ineffective esophageal motility, providing quantitative pressure metrics (e.g., integrated relaxation pressure >15 mmHg indicating outflow obstruction) to guide and evaluations.

Products

PillCam Capsule Systems

The PillCam capsule systems represent a core product line developed by Given Imaging for noninvasive visualization of the tract using ingestible camera capsules. These systems leverage wireless technology to capture high-resolution images of the mucosa, aiding in the diagnosis of various GI conditions through patient-friendly procedures that avoid or invasive instrumentation. The PillCam SB capsule is the standard variant for small bowel evaluation, primarily indicated for detecting abnormalities such as obscure GI bleeding, lesions, and not identified by traditional . It features a 156-degree and an adaptive of 2 to 6 frames per second, enabling detailed imaging as the capsule transits the over approximately 8 to 12 hours. The system includes the Suspected Blood Indicator software tool, which highlights potential angiodysplasias or bleeding sources by marking relevant video frames for clinician review. The PillCam ESO capsule targets esophageal assessment, particularly for visualizing abnormalities associated with (GERD), such as or . It employs a higher of 14 images per second with dual imagers providing forward and backward views, allowing real-time monitoring via an external recorder and monitor during the rapid esophageal transit. This design supports efficient detection of mucosal changes without requiring retrieval tethers in standard use. For colonic examination, the PillCam COLON 2 capsule incorporates dual cameras offering forward and backward perspectives with a combined nearly 360-degree (172 degrees per camera), facilitating polyp detection in patients following incomplete colonoscopies or with poor bowel preparation. Clinically, it demonstrates per-patient sensitivity exceeding 88% for significant lesions greater than 6 mm in diameter, supporting its role as an alternative for colorectal screening. The PillCam Crohn's capsule builds on the SB platform with specialized software for quantifying small bowel inflammation in Crohn's disease patients. It utilizes validated scoring systems, such as the Lewis score or Eliakim score, to assess mucosal damage severity—categorizing findings as normal (score <135), mild (135–790), or significant (>790)—and correlates these endoscopic metrics with the Crohn's Disease Activity Index for comprehensive disease monitoring. Post-2019 enhancements to the PillCam platform, including the software updates, integrate for automated lesion detection and triage, reducing video review times by up to 50% through prioritization of suspicious frames and elimination of non-informative segments. This has streamlined workflows. Across all variants, PillCam systems have facilitated over 3.5 million procedures worldwide as of 2020. Contraindications include known obstructions, strictures, or swallowing disorders that could impede safe capsule ingestion and transit. For patients unable to swallow, the PillCam Express delivery device allows transendoscopic placement.

Bravo pH Monitoring System

The Bravo Monitoring System is a , catheter-free device designed to measure esophageal levels over an extended period, aiding in the diagnosis of () and related esophageal disorders. Developed by Given Imaging and now marketed by following acquisitions, the system consists of a small, oblong-shaped -sensing capsule measuring 6 mm × 5.5 mm × 25 mm, equipped with an , , , and radio transmitter. The capsule is delivered via a specialized system during an upper , allowing attachment to the esophageal mucosa approximately 6 cm above the squamocolumnar junction. An external, pager-sized receiver worn by the patient captures transmitted data ly, enabling up to 48 hours of continuous monitoring without restricting daily activities. The procedure begins with endoscopic placement of the capsule under mild , where the endoscopist uses the delivery to the esophageal wall and secure the capsule via a clip , typically taking just a few minutes. Post-placement, patients resume normal diet and activities, logging symptoms in a diary while wearing the receiver; the capsule naturally detaches after 7-10 days and is passed through the digestive tract. Collected data is downloaded and analyzed using software that calculates key metrics, such as the DeMeester score—a composite index incorporating percentage of time <4, number of reflux episodes, and longest episode—where scores greater than 14.7 indicate abnormal acid exposure consistent with GERD. This approach provides a more accurate representation of reflux patterns compared to shorter monitoring durations. Indicated primarily for patients with refractory GERD symptoms unresponsive to proton pump inhibitors or those being evaluated prior to laparoscopic fundoplication surgery, the Bravo system offers significant advantages over traditional catheter-based pH monitoring, including reduced discomfort, less nausea (reported in under 10% of cases versus 40-50% with catheters), and higher patient compliance due to the absence of a transnasal tube. Attachment success rates exceed 95%, with the wireless design minimizing interference with eating, sleeping, and work, thereby capturing more representative reflux events over the full monitoring period. A variant, the Bravo pH + impedance system, combines pH sensing with multichannel intraluminal impedance to detect both acid and non-acid reflux episodes, enhancing diagnostic utility for atypical or weakly acidic reflux symptoms. In June 2025, the FDA issued a Class I recall for certain lots of the Bravo calibration-free (CF) capsule delivery devices due to manufacturing issues with adhesive application, which could lead to improper capsule attachment or failure to detach from the delivery system, posing risks of esophageal perforation, aspiration, airway obstruction, or bleeding; as of that time, 33 serious injuries were reported with no deaths. The recall remains open as of November 2025. Clinical studies demonstrate that the Bravo system improves GERD diagnosis accuracy to 85-90% when compared to symptom-based assessments alone, with extended monitoring increasing detection of abnormal reflux by up to 20% over 24-hour tests, particularly in identifying day-to-day variability. Post-acquisition integration into Medtronic's gastrointestinal diagnostic suite has facilitated compatibility with other tools like manometry systems, streamlining workflows in motility clinics for comprehensive esophageal evaluation.

Acquired Diagnostic Systems

The Acquired Diagnostic Systems section of Given Imaging's portfolio stems from its acquisitions of Sierra Scientific Instruments in 2010 and the assets of SmartPill Corporation in 2012, expanding capabilities in gastrointestinal motility assessment beyond visual endoscopy. The Sierra acquisition introduced the ManoScan™ ESO high-resolution manometry system, which utilizes Medical Measurement Systems (MMS) consoles paired with solid-state catheters featuring up to 36 circumferential pressure sensors spaced at 1 cm intervals. This setup enables precise measurement of esophageal sphincter pressures, including lower esophageal sphincter resting pressure and relaxation, as well as peristaltic wave propagation, facilitating the diagnosis of motility disorders such as achalasia, where impaired esophageal body peristalsis and incomplete sphincter relaxation are hallmark findings. The system received FDA 510(k) clearance in 2009 for esophageal motility testing. Complementing this, the SmartPill motility capsule, a single-use, ingestible wireless device approximately 26 mm by 11 mm, recorded parameters including pH, pressure, and temperature to track regional gastrointestinal transit times without ionizing radiation. Normal gastric emptying time is typically 2-5 hours, small bowel transit 2-6 hours, and colonic transit 10-59 hours, with the accompanying software generating automated reports that identify delays indicative of gastroparesis (e.g., gastric emptying >5 hours) or chronic constipation in (IBS) patients. Originally FDA-cleared in 2006 for gastric emptying and expanded in 2009 for colonic transit evaluation, the system saw post-acquisition enhancements under Given Imaging, including improved data analysis integration by 2013. However, discontinued the SmartPill in July 2023 due to issues, with no further sales after inventory depletion; it had been adopted in over 50 countries as a radiation-free alternative to or marker studies, though limited to physiological metrics. These systems integrated with Given Imaging's PillCam capsule endoscopy platform to provide a comprehensive evaluation of both structural and functional gastrointestinal issues, allowing clinicians to correlate visual findings with data for more accurate diagnoses of disorders like small bowel dysmotility. The ManoScan system remains available under , with enhancements in the 2020s including refined wireless data synchronization and software updates for seamless receiver-to-console connectivity, improving workflow efficiency in clinical settings.

Operations

Headquarters and Manufacturing Facilities

Given Imaging's original headquarters was established in Yoqneam, , in , housing corporate administration, laboratories, and operations in a facility spanning approximately 10,300 square meters (over 110,000 square feet). This site employed around 247 personnel in as of 2008, representing about 51% of the company's total workforce at the time, with roles spanning R&D, , sales, and administration. The Yoqneam facility serves as the primary manufacturing hub for capsule assembly, utilizing multiple semi-automated production lines for PillCam small bowel (SB), esophageal (ESO), and colon capsules, as well as the Agile patency capsule. The site's capacity has been expanded over time through investments, such as $2 million in machinery in 2008, to meet growing demand for diagnostic capsules. In 2010, Given Imaging acquired Sierra Scientific Instruments for $35 million, integrating manometry production capabilities through Sierra Scientific Instruments, with its headquarters in , , and manufacturing operations in , to broaden its gastrointestinal diagnostic portfolio. This acquisition enhanced manufacturing for high-resolution manometry systems used in esophageal and anorectal diagnostics. Following the 2014 acquisition by and subsequent integration into in 2015, Given Imaging's operations were centralized within 's global supply chain, leveraging the parent company's infrastructure for distribution and quality oversight. The facilities maintain certification, aligning with international standards for systems.

Global Presence and Current Status

Given Imaging, following its acquisition by Covidien in 2014 and integration into in 2015, operates as part of Medtronic's Gastrointestinal () business unit with a global footprint including offices in the United States, , and . Its diagnostic products, such as the PillCam capsule systems, are distributed in over 80 countries worldwide, supporting clinical use in diverse healthcare settings from to and . Prior to the acquisition, Given Imaging employed approximately 800 individuals, with a strong emphasis on centered in Yokneam, . Today, these operations are fully integrated into Medtronic's global workforce of more than 95,000 employees, retaining a dedicated focus on GI innovation and R&D at the Israeli facility while leveraging Medtronic's broader resources for and distribution. As of , GI continues to lead in minimally invasive diagnostics, with the PillCam and pH monitoring systems contributing to the market, projected at USD 479 million globally. Ongoing innovations include AI-enhanced diagnostics, such as the GI Genius™ module for detection during colonoscopies, building on Given Imaging's foundational capsule technology. The unit maintains key regulatory approvals, including FDA clearance and CE Mark certification for its core products, ensuring compliance across major markets. However, operations face challenges from global disruptions, including shortages of electronic components for capsule manufacturing amid geopolitical tensions and semiconductor constraints.

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