Endoscopy

Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. The new, more cost-effective design, based on the long-standing success of the DiLumen EZ-Glide platform, has been modified and streamlined. “The…

Limaca Medical (“Limaca”) announced that its Precision-GI™ Endoscopic Ultrasound Biopsy Product has received a Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”). The Precision-GI™ device is designed to obtain tumor tissue within or adjacent to the gastrointestinal tract. Endoscopic biopsy is performed by a gastroenterologist who accesses the targeted GI tumor utilizing an…

EvoEndo®, Inc. (“EvoEndo”), a medical device company developing systems for Unsedated Transnasal Endoscopy (TNE), has announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin marketing and sale of the EvoEndo® Single-Use Endoscopy System. The clearance follows EvoEndo’s distribution agreement with Micro-Tech Endoscopy USA, Inc. (“Micro-Tech”), which will begin…

Ambu announces the 510(k) regulatory clearance of the Ambu® aScope™ Gastro and Ambu® aBox™ 2 in the United States. aScope Gastro is Ambu’s first sterile single-use gastroscope and includes new advanced imaging and design features in a combined solution with next-generation display and processor technology. With HD capabilities, the aBox 2 will set a new…

Intersect ENT, Inc., a company transforming care for patients with ear, nose and throat (“ENT”) conditions, today announced it has entered into an agreement to acquire Fiagon AG Medical Technologies, a leader in electromagnetic surgical navigation solutions, for €60 million in cash. Under the terms of the transaction, Intersect ENT will make an initial €15 million payment at…

Ethicon, part of the Johnson & Johnson Medical Devices Company, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for transbronchial microwave ablation technology using robotic-assisted bronchoscopy, which is currently under development. The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or…

PENTAX Medical, a healthcare industry leader in diagnostic and therapeutic endoscopy, has announced the United States launch of its DEC™ HD Duodenoscope, an advanced, high-definition duodenoscope that features multiple disposable components, including the sterile distal cap and elevator lever, for unit reprocessing. The DEC HD Duodenoscope is designed to provide physicians a solution aligned with recent…

GI Scientific, LLC, a developer of transformative innovations for gastrointestinal disease, announced that the U.S. Food and Drug Administration (FDA) cleared its ScopeSeal® Duodenoscope Protective Device, the first Endoscopic Shield® for protecting the distal end of a duodenoscope from contamination during ERCP procedures. ScopeSeal® is a single-use disposable infection control device that preserves duodenoscope optics and other…

  SetPoint Medical’s open-label study supports the use of the company’s bioelectronic therapy for Crohn’s Disease. The Valencia,CA-based company’s study was conducted at five European sites and included 16 patients with moderate to severe Crohn’s Disease with inadequate responses to tumor necrosis factor (TNF) antagonist drugs and other non-TNF targeted biologic agents. The data, presented…

Harvard researchers have created a rigid-soft robotic arm for endoscopes that can sense, flex and has multiple degrees of freedom. Flexible endoscopes fit through narrow passages to reach difficult parts of the body. Once they reach their target, the devices need rigid surgical tools to be able to manipulate or remove tissues. Researchers from Harvard’s…