medical device guru

Surgery and Surgical Robotics

Lumendi Receives 510(k) Clearance for Two New Devices

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...

February 21, 2023

Surgery and Surgical Robotics

Limaca Medical Receives FDA Breakthrough Device Designation

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....

May 13, 2022

Surgery and Surgical Robotics

EvoEndo Announces US FDA 510(k) Clearance for their Single-Use, Unsedated Transnasal Endoscopy System

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....

February 17, 2022

Surgery and Surgical Robotics

Ambu Announces FDA Clearance of Single-Use Gastroscope and Next-Generation Display Unit

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...

February 8, 2022

Surgery and Surgical Robotics

Intersect ENT Announces Agreement to Acquire Fiagon for $71M

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...

September 15, 2020

Surgery and Surgical Robotics

U.S. FDA Grants Ethicon Breakthrough Device Designation for Monarch-enabled NeuWave Microwave Ablation Technology

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...

July 31, 2020

Surgery and Surgical Robotics

PENTAX Medical Launches DEC HD Duodenoscope in the United States

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...

November 25, 2019

Surgery and Surgical Robotics

U.S. FDA Clears GI Scientific’s ScopeSeal®, the Only Single-Use Disposable Device Indicated to Significantly Reduce Duodenoscope Contamination

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...

October 24, 2019

Surgery and Surgical Robotics

Positive Clinical Data for Penny-Sized Bioelectronic Implant

  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...

June 12, 2018