FDA Allows At-Home Capsule Endoscopy Administration

CapsoCam Plus® is a pill sized capsule endoscopy system that when ingested takes millions of pictures with a 360° panoramic view of the small bowel providing the physician with greater ability to diagnose patients accurately. 

Amidst the global COVID-19 pandemic, The FDA has granted enforcement discretion allowing CapsoVision the ability to launch at-home administration of CapsoCam Plus®. This device consists of a  video capsule system intended for further visualization of the small bowel mucosa in adults. 

Gastrointestinal (GI) endoscopes are flexible visualization instruments that are inserted into the alimentary canal for diagnostic or treatment purposes. GI endoscopes can be maneuvered to access the majority of the GI tract; however, some sections are more difficult than others to reach. The small intestine, for example, contains distal regions that make physical access far too challenging to carry out successfully. This has led to the development of capsule endoscopy, a market that competes directly with the GI endoscope market.

“CapsoVision’s advanced capsule technology delivers high-quality diagnostic images without creating a risk of in-person exposure to COVID-19.”

 Johnny Wang, president, and chief technology officer at CapsoVision.

CapsoCam for Capsule Endoscopy

Based on research done by iData Research, the capsule endoscopy market was first introduced in the U.S. in 2001 by a company based out of Yokneam, Israel. Over the years, Medtronic and Olympus acquired leading positions in the market followed by IntroMedic and CapsoVision.

CapsoVisions’s CapsoCam® is a self-contained capsule endoscopy system that does not require external equipment provided by a doctor. The patients must simply ingest the capsule to initiate the monitoring process. They proceed with their daily activity while the capsule can capture information while a physician can review the data through cloud-based software. 

The FDA enforcement discretion allows for a completely hands-off approach to endoscopy procedures. With COVID-19 cases still on the rise, any products that can limit in-person interactions are greatly beneficial for both the patients and medical professionals.

Compared to the alternative end facing cameras the CapsoCam Plus® provides a 360 panoramic view of the entire small bowel. This increased visibility and higher resolution increase the chances of catching more lesions, celiac disease cases, ulcers, and active bleeding. In turn, this can lead to more accurate diagnosis and treatment plans for patients. 

Capsule Endoscopy Market Analysis and Forecast

A  recent study CapsoCam Plus® shows that the US Capsule Endoscopy market was valued at $96 million by 2020. CapsoVision was the largest entrant in the U.S. market in 2016 with the launch of its first product, CapsoCam®. They had a large advantage over the competition with the 360-degree view and absence of a data recorder. While 90% of the Capsule Endoscopy market is still being dominated by Medtronic, the new FDA approval  is expected to bring Capsovision an increase in unit sales and usage of their product over the competition. 

Register to receive a free U.S. Market Report Suite for Gastrointestinal Endoscopic Devices 2019 – 2025 synopsis

The Capsule Endoscopy market is expected to reach over $135M by 2025, with camera capsules representing around 92% of the total market. The camera capsule market size is forecast to see steady growth in both the short and long term. The current market drives include favorable reimbursements along with expanding indication for the esophageal and colonic market. In the long term, the camera capsule market is expected to benefit from ongoing research addressing the major limitation of the device, such  as its non-therapeutic nature and lack of control of the capsule passage.

Via: MassDevice, CapsoVision

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