EnlightenVue’s Single-Use Micro Endoscope Receives FDA 510(K) Clearance

The novel single-use micro-endoscope with multiple working channels, eliminates the risk of transmitting infections between patients.

News
Category:
Published on:
March 31, 2020

FRAMINGHAM, Mass., March 31, 2020 /PRNewswire/ — enlightenVue™ (https://enlightenvue.com), creators of the surgiVue™ single-use platform of micro endoscopes announced today that their product has received 510(k) marketing clearance from the Federal Drug Administration (FDA).

According to the FDA: “The use of the enlightenVue Microendoscopy System is intended for the visualization of body cavities, hollow organs, and canals. It is also designed to be introduced through natural body orifices cavities or surgical incisions through introducers, trocars, needles, sheaths, or other devices with lumens having inside diameters larger than the outer diameter of the endoscope.”

Receiving this broad and general indication from the FDA gives enlightenVue the ability to market the unique surgiVue endoscope for multiple clinical and surgical procedures. EnlightenVue will immediately pursue several clinical trials in numerous medical and surgical specialties.

This is the only two millimeter, single-use micro endoscope on the market with two working channels,” said Giacomo Basadonna, Chief Executive Officer. “The surgiVue endoscope will protect patients from the risk of hospital-acquired infections that can be contracted from reusable endoscopes, as indicated by several FDA guidance documents. Additionally, the presence of two working channels allows health care providers to perform interventional procedures (rather than simple diagnostic ones) in a minimally invasive setting.”

We are proud to have enlightenVue as an Alira Health Ventures portfolio company and are impressed with the speed and efficiency with which they achieved FDA clearance,” said Gabriele Brambilla, Chief Executive Officer of Alira Health and head of the firm’s investment arm, Alira Health Ventures. “It has only taken two and a half years from the initial sketch to 510(k) clearance, and this incredible technology is now poised to disrupt the market and offer a new level of safety and protection to patients.

EnlightenVue’s micro endoscope is single-use and does not require cleaning and/or re-sterilization, eliminating the risk of patient-to-patient transmission of microorganisms caused by difficult to disinfect and sterilize reusable endoscopes. This is of importance during the current viral pandemic where direct contagion must be avoided. In addition, the single-use surgiVue endoscope provides financial advantages to the healthcare system by eliminating the sterilization, repair and personnel costs associated with reusable endoscopes, reducing downtime and inventory logistics. The novel micro-endoscope allows for a combination of diagnostic and interventional procedures, simplifies the patient’s overall experience from diagnosis to treatment, and gives the provider a wide range of clinical options.

Please direct inquiries to [email protected].

About EnlightenVue:

EnlightenVue developed a novel single-use micro endoscope that can be used for both diagnostic and interventional procedures with high-definition image quality. The micro endoscope’s unique high-intensity laser light can deliver up to 20 times the light of ordinary sources while producing sharper images and better contrast. The high-intensity laser light delivers cool, high-lux illumination that can be efficiently coupled into light channels that are paired with fibers of the smallest size.

To learn more about Alira Health

Contact us

Related news

Events September 7, 2022
MDIC Annual Patient Forum 2022
We are pleased to share that we will be joining as speakers MDIC Annual Patient Forum 2022 – a key platform for the discussion of how to transform patient engagement throughout the(...)
Clinical Trials MedTech Patient Engagement
Events August 31, 2022
BIOMEDevice 2022
We are excited to share that we will be joining BIOMEDevice 2022 as speakers! This event will bring engineers, business leaders, disruptive companies, and innovative thinkers from the(...)
Investor Relations Medical Devices MedTech
Multimedia August 29, 2022
Webinar Replay: Clinical Trial Management in MedTech & Working with CROs
As a MedTech company, understanding clinical trial management is critical, and working with CROs is part of the journey. Join the webinar to learn about this crucial topic.
Clinical Trial Management CRO MedTech
Events August 23, 2022
MedtechVision 2022
Join us at the MedtechWomen MedtechVision Conference, where we will be presenting a state of the Medtech Industry Report with an overview of the innovation and advancement and much more.
Diagnotics MedTech Patient Centricity
Publications August 4, 2022
White Paper: New European Health Technology Assessment Regulation
In this white paper, we provide an overview of this new regulation, including key points of the new European Health Technology Assessment Regulation, its methodology, and its timelines.
MedTech Regulatory
Multimedia July 12, 2022
Webinar Replay: What You Should Know About MDR Best Practices, Including PMCF
Discover the major changes introduced by the MDR, including the post-market requirements, and especially the Post-Market Clinical Follow-up (PMCF).
MedTech Regulatory
July 7, 2022
Webinar Replay: Best Practices to Incorporate Diversity and Inclusion in MedTech
Watch this on-demand webinar to gain insight into the topic of diversity and inclusion as it applies across the product lifecycle and more.
Diversity Inclusion MedTech
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.