Medical device and MedTech insights, news, tips and more

FDA Allows At-Home Administration for CapsoVision Capsule Endoscope

September 28, 2020


a hand holding the capsovision capsule between two fingersCapsoVision, an innovator in the gastroenterology diagnostics market, today announced that the U.S Food & Drug Administration (FDA) will apply enforcement discretion which allows at-home administration of the CapsoCam Plus® small bowel capsule endoscope during the COVID-19 pandemic for patients who are determined eligible for at-home administration.

The labeling addendum permits a fully remote capsule endoscopy procedure for eligible patients, eliminating the need for in-person interaction between clinic staff and patient.

CapsoVision’s advanced capsule technology delivers high-quality diagnostic images without creating a risk of in-person exposure to COVID-19,” stated Johnny Wang, President and CTO. “Our team is proud to contribute during the pandemic and to continue to innovate within the emerging telehealth paradigm.” 

Along with its impressive 360° panoramic view, CapsoCam Plus is the only self-contained capsule endoscopy system that does not require external equipment that must be worn by the patient, returned to the clinic in 8-12 hours and disinfected between use. Patients simply ingest the capsule and return to their normal activities while the exam data is being captured. The images can then be easily reviewed by the physician via the CapsoCloud® cloud-based software, from anywhere there is internet access.

The COVID-19 pandemic has challenged all physicians to rethink the way we deliver care now, and going forward,” said Javier Parra, MD, Gastroenterologist in Miami, FL with Gastro Health.” We need to do everything possible to continue to deliver healthcare in a timely and safe manner, while making an effort to reduce in-person contact and potential Coronavirus exposure. The CapsoCam Plus system will now allow us to offer this procedure to the appropriate patients efficiently and effectively, without the patient needing to visit the clinic.  This is an added value to our practice and enables us to reduce exposure risks to our patients and staff while continuing the normal volume of office visits.”

The CapsoCam Plus video capsule system is intended for the visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

See Full Press Release at the Source: CapsoVision Inc. Announces FDA Enforcement Discretion for At-Home Capsule Endoscopy Administration of CapsoCam Plus during COVID-19

Press Release by CapsoVision Inc

Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.

More insights

March 7, 2024
FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
Learn More
March 1, 2024
FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Learn More
February 21, 2024
Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.