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Endoscopic Units Articles & Analysis
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” About GI Dynamics GI Dynamics Inc. is the developer of EndoBarrier, an endoscopically delivered device therapy which offers a non-surgical, alternative treatment for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale in the United States and is limited by federal law to investigational use only. ...
In 2019, the company launched a new US IDE study, the STEP-1 Study, in the United States to study the EndoBarrier System. EndoBarrier is intended for patients who do not have adequate control of their type 2 diabetes and obesity through their current medication and lifestyle. ...
MedTech Innovator, the world’s largest accelerator of medical technology companies, yesterday named Lazurite as one of the MedTech industry’s hottest 50 companies by selecting it to participate in Medtech Innovator’s flagship four-month Accelerator program featuring medical device, diagnostic, and digital health technologies from around the globe. As a 2022 Cohort member, ...
EvoEndo, Inc. (“EvoEndo”), a medical device company which developed a single use system that allows for unsedated Transnasal Endoscopy (TNE), has announced the completion of an $8.4 million Series A financing round led by founding investor TLP Investment Partners LLC (TLP) and including the Sunshine Charitable Foundation and the Jill and Paul Meister family. Proceeds from the ...
ByEvoEndo
A new biopsy sheath developed by Raleigh med tech startup UVision360 is ready to hit the market after landing federal approval this week. UVision360 announced it had received the greenlight from the U.S. Food and Drug Administration for its patented LUMINELLE 360° Bx Sheath. The device expands the startup’s “all-in-one” gynecological system LUMINELLE DTx, an endoscopic ...
The E-View.AI provides leading-edge technology that dramatically reduces radiation exposure to patients and staff during endoscopic procedures. The Omega system offers several advantages that conventional fluoro systems cannot: AI automatically detects the physician’s ROI – allowing for hands-free operation Delivers the highest level of image quality for the ...
The EvoEndo System ultimately enables safer and more cost-effective upper endoscopic procedures for patients, doctors, and hospitals. The FDA clearance is the latest milestone for EvoEndo, who also announced the completion of a $10.1M equity financing round last June. ...
ByEvoEndo
Medical device and technology company Lazurite Holdings LLC today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its ArthroFree™ wireless camera system for minimally invasive surgery, and that the submission has been accepted for review. The company also announced that early-stage healthcare investment platform AngelMD named it ...
Custom Ultrasonics Inc. (CUI) was established in 1981 by Frank J. Weber to design, manufacture and distribute automated systems to clean and high-level disinfect complex devices including multi-channeled flexible endoscopes. The company is currently led by Alicia Nakonetschny. Wassenburg Medical B.V., originally a family company, is now in a joint venture with Hoya since 2013. The company was ...
Medical device and technology company Lazurite Holdings LLC has been recognized by MedTech Outlook magazine as a 2021 Top 10 Endoscopy Device Provider for its ArthroFree™ wireless camera system for minimally invasive surgery. MedTech Outlook describes itself as a platform that bridges the spectrum between medtech technology providers and healthcare facilities and medical institutes. In ...
EvoEndo®, Inc. (“EvoEndo”), a medical device company developing systems for unsedated endoscopy, today announced the signing of a distribution agreement with Micro-Tech Endoscopy USA, Inc. (“Micro-Tech”). The agreement, whereby Micro-Tech will distribute the EvoEndo® Single-Use Endoscopy System in the US, is expected to begin pending US FDA 510(k) clearance. ...
ByEvoEndo
Sanford, Florida (July 28, 2021) — Omega Medical Imaging, the leading innovator in AI image-guided interventional systems for hospitals and healthcare facilities around the world, announced the installation of the E-View.AI interventional endoscopy system at the Pali Momi Medical Center in Hawai’i. The E-View.AI represents the first AI image-guided system in the state of ...
UVision360, Inc., an innovative medical device company, announces today that the U.S. Food and Drug Administration (FDA) has approved the Company's expanded reprocessing procedures for use with the LUMINELLE DTx System. This expansion will allow the LUMINELLE DTx System to be more fully utilized in broader settings such as Hospital Systems and Outpatient Surgical Centers. It will also support ...
UVision360, Inc., an innovative medical device company, announces today that the U.S. Food and Drug Administration (FDA) has approved the patented LUMINELLE 360° Bx (Biopsy) Sheath which expands the capability of the LUMINELLE® DTx System. The LUMINELLE 360° Bx sheath, combined with the LUMINELLE DTx System, is the first and only integrated directed biopsy device not requiring ...
In addition, Scivita Medical has various single-use endoscopy devices with international competitiveness, many of which have entered the clinical, registration, or sales stages in China, the United States, Europe and other countries and regions, respectively Given that endoscope industry has entered into the era of consumables, Scivita Medical will compete with ...
UVision360, Inc., an innovative FemTech company, announces today that the U.S. Food and Drug Administration (FDA) has accepted the Company's submission for expanded reprocessing procedures for use with the LUMINELLE DTx Hysteroscopy System. Supported by STERIS® Device Testing procedures, UVision360, Inc. is adding the Revital-Ox® RESERT® HLD as a high-level disinfectant method and ...
UVision360, Inc., an innovative FemTech company, announces today that the United States Patent and Trademark Office has issued a system method patent, No.10926059, for the Company's LUMINELLE® DTx System (LUMINELLE). ...
January 13, 2021 (Press Release) – PLANO, Texas. AnX Robotica Corporation, (www.anxrobotics.com), the developer and manufacturer of the NaviCam Magnetically Controlled Capsule Endoscopy (MCCE) System, is pleased to announce that the American Medical Association (AMA) has issued a new Current Procedural Terminology (CPT) code for Magnetically controlled capsule endoscopy, which can help ...
If you’ve ever had an awful sinus infection, you know how painful, and quite frankly, how much of a drag it is. But most of us don’t have Chronic Sinusitis, which consists of a sinus infection lasting longer than 3 months (despite treatment), according to the Mayo Clinic. That being said, 11.6% of the American population does, says the CDC. For years, if doctors couldn’t bring ...
GI Dynamics remains focused on attaining a CE mark for EndoBarrier, initiation of the I-STEP trial in India and resumption of the STEP-1 pivotal trial in the United States, pending the removal of COVID-19 related restrictions. About GI Dynamics GI Dynamics®, Inc. is the developer of EndoBarrier®, the first endoscopically delivered medical device for the ...