DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Mobile Imaging
SEARCH
Current Location:
>
> This Story


Log in or Register to rate this News Story
Forward Printable StoryPrint Comment
advertisement

 

advertisement

 

Endoscopy Homepage

NinePoint Medical's NvisionVLE AI software upgrade gets FDA nod Designed to be a great help to gastroenterologists worldwide

Body Vision gets FDA nod for its navigation catheter Works with the LungVision Imaging and Navigation System

Q&A with Dr. Camran Nezhat, the father of video endoscopy Great innovations are initially often met with skepticism

Fujifilm enters the US minimally-invasive surgery market Its new Boston-based business launched new products

New camera inspired by butterfly eyes helps surgeons remove all cancerous tissue May cost as little as $200

FDA warns duodenoscope makers about failure to comply with requirements Reprocessing issues resurface for Olympus, Fujifilm and Pentax

David Woods PENTAX Medical appoints veteran executive as the Americas region president and CEO

DePuy Synthes unveils PUREVUE Visualization System An imaging platform for minimally-invasive endoscopic surgery

Olympus expands its EndoTherapy product line One new device and two business deals

Dr. Adam J. Goodman NYU Langone Hospital – Brooklyn hires a new director of endoscopy and quality to its department of medicine.

Creo Medical's Speedboat RS2 gains FDA clearance 'ahead of schedule'

by Thomas Dworetzky , Contributing Reporter
Creo Medical Group's Speedboat RS2 device and its CROMA platform received 510(k) clearance, the surgical endoscopic device maker has announced.

Speedboat RS2, powered by the microwave-based CROMA platform, permits “minimally invasive” endoscopic removal of early stage cancerous and precancerous lesions in the bowel.

Story Continues Below Advertisement

THE (LEADER) IN MEDICAL IMAGING TECHNOLOGY SINCE 1982. SALES-SERVICE-REPAIR

Special-Pricing Available on Medical Displays, Patient Monitors, Recorders, Printers, Media, Ultrasound Machines, and Cameras.This includes Top Brands such as SONY, BARCO, NDS, NEC, LG, EDAN, EIZO, ELO, FSN, PANASONIC, MITSUBISHI, OLYMPUS, & WIDE.



This FDA review took just 49 days, and will let the Wales-based company turn its attention to U.S. commercial planning early.

"We continue to execute against our plan and, in this case, come in well ahead of our targets,” said CREO CEO Craig Gulliford, adding that, “this bodes well and provides us with confidence that we have the foundation in place to execute on the suite of devices currently in development."

The approval came almost two quarters ahead of schedule.

"The next step is to roll out the training course that is underway in Europe at the moment and start rolling that into physicians in the U.S.," he told Reuters.

Speedboat RS2 is the first of a number of planned devices that will use the CROMA generator.

The use of Speedboat RS2 “reduces the risks associated with incisions, which are necessary for laparoscopic procedures and can reduce the length of hospital stay,” the company stated, noting that this is due to its ability to coagulate bleeding vessels with its microwave energy, and to cut or resect with that energy, with minimal risk of puncturing surrounding tissue.

The device has a number of features, including:

  • Its ability to maintain submucosal lift with an integrated injection needle, with no instrument changes required

  • Bipolar radiofrequency cutting for precise lateral and forward dissection

  • Microwave coagulation, providing controlled hemostasis

  • A protective hull, reducing risk of muscle damage

  • An optimized shaft design, enabling controlled rotation


There are now more than 16 million colonoscopies performed annually, and 1.1 million of these find a lesion that needs treatment, of which half are surgically removed.

"Surgical endoscopy is an emerging field and we believe that with the CROMA system, Speedboat and our suite of products, we are well positioned to become a leader in this billion-dollar-plus market," advised Gulliford.

In March, the Speedboat RS2 received its CE Mark approval for microwave energy to add to the device's previously awarded CE Mark for radiofrequency.

Clinical studies had shown it to be safe and efficacious in the application of microwave energy to coagulate bleeds in the colon in 30 patients, according to a report published in Digestive Disease Week at that time.

In 2016, Creo made its stock market debut and raised over $26.5 million from investors. At that time, Gulliford told the Telegraph, “our product enables procedures that are currently only done in the operating theatre to be done in the endoscopy room, so we go from requirement of a general anesthetic to a local one or sedation.”

“It’s using God-given access to a body rather than an incision,” he added, noting, “The other thing that makes this different is that the microwave energy that stops the blood flow can be delivered in a very precise, minimal way."

Endoscopy Homepage


You Must Be Logged In To Post A Comment

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Central
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2018 DOTmed.com, Inc.
ALL RIGHTS RESERVED