Therapy Areas: Devices
Recent FDA Ruling Grants Patients Expanded Access to Remote Ingestion Protocol with CapsoCam Plus During the COVID-19 Pandemic
16 October 2020 - - Japan-based diagnostic and therapeutic endoscopy solutions provider Pentax Medical has launched expanded availability of the CapsoCam Plus video capsule system, an ingestible small bowel capsule endoscope, as part of an Discretionary Enforcement Policy enacted by the US Food and Drug Administration to expand the availability of remote digital pathology during the COVID-19 pandemic, the company said.

The special expanded labeling grants patients access to a mechanism for evaluating the small intestine, a part of the bowel that cannot be reached by traditional upper endoscopy or colonoscopy, while eliminating the need for in-person interactions between clinicians and their patients.

The CapsoCam Plus video capsule system, which is manufactured by CapsoVision, Inc. and distributed exclusively in the United States and Canada by Pentax Medical, is the only self-contained capsule endoscopy system that does not require external equipment that must be worn by the patient.

Eligible patients swallow the device under supervision of a physician during a video call.

As the pill-sized device passes through the middle portion of the gastrointestinal tract, it captures 360-degree visualization of the duodenum, jejunum and ileum. The footage is later downloaded and placed on the cloud for physician review.

The CapsoCam Plus video capsule system is the only capsule endoscopy system on the market with 360° lateral viewing ability.

Importantly, the device contains its own light source and images are stored on the device, thus eliminating the need for patients to wear an external sensor belt or recording instrument.

This exclusive feature of the CapsoCam Plus video capsule system improves comfort, reduces associated costs, and increases ease of use.

After the capsule has passed through the system, a specialized retriever tool is used to collect the capsule, which is then packaged and shipped to a laboratory.

Once there, images are retrieved and loaded to the CapsoCloud, a HIPPA-compliant data management and storage system that connects to the CapsoView software interface for physician viewing and evaluation.

This FDA's Discretionary Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency was enacted to expand the availability of remote digital pathology devices that may help facilitate pathology services while reducing healthcare personnel contact and risk of potential exposure to COVID-19 through remote reviewing and reporting.

The policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 as declared by the Department of Health and Human Services.

Pentax Medical is a division of Hoya Group. Through R and D and manufacturing, Pentax Medical provides endoscopy solutions to the global medical community.
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