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New View Surgical, Inc. Announces FDA Clearance of its VisionPort™ System for Minimally Invasive SurgeryNew View Surgical, Inc., received clearance from the U.S. FDA for its VisionPort™ System see more
The VisionPort™ is the first surgeon-controlled, multi-camera laparoscopic visualization system.
BOSTON, MA - June 22, 2021 New View Surgical, Inc., a medical device company developing proprietary imaging and access technologies for minimally invasive surgery (MIS), announced today that it received 510(k) clearance from the U.S. Food and Drug Administration for its VisionPort™ System. The VisionPort™ imaging and access system simplifies laparoscopic procedures for hospitals and provides surgeon-controlled visualization. Its dual-camera design offers multiple, simultaneous views of the anatomy and surgical instrumentation – unavailable with conventional laparoscopic systems. The VisionPort puts the most advanced visualization technology more readily in the hands of customers and is intended to be used in a broad range of diagnostic and therapeutic procedures within the thoracic and abdominal cavities. It is adaptable to a wide variety of surgical environments, representing a significant market opportunity.
“The VisionPort System allows the surgeon to control the scope and keeps the tip of the instruments within the field of view at all times. This has significant potential to make the operation easier for the surgeon and reduce risk to the patient,” commented David Earle, MD, FACS, Director of the New England Hernia Center and Associate Professor of Surgery at Tufts University School of Medicine in Boston, MA. “Additionally, the VisionPort provides multiple, simultaneous views of the operative field. Previously, changing the viewing angle was only possible by removing the laparoscope and moving it to another port, frequently wasting time and causing frustration. Furthermore, the VisionPort eliminates a separate incision and the need for a surgical assistant to hold the scope. The elimination of the camera port and assistant means surgeons and hospitals can expand access to the operating room without increasing staffing requirements. This increased efficiency is good for the surgeon, the facility, and most importantly, the patient.”
Added Dr. Earle, “It’s been exciting to collaborate with the New View Surgical team during the development of the VisionPort. Not only will this technology allow more patients to access minimally invasive surgical techniques, but it will also make many high volume procedures easier for surgeons to perform.”
“FDA clearance of the VisionPort is a significant milestone for New View Surgical. We’re excited to bring revolutionary technology to market that supports our overall mission to improve the outcomes and efficiency of laparoscopic surgical procedures, all while increasing patient access to minimally invasive surgical techniques worldwide,” said Bryce Klontz, President & CEO. “The FDA clearance process for the VisionPort was completed in less than 90 days. We are incredibly pleased with the timeline as we can now move ahead with the next stages of company development and commercialize this exciting technology.”
ArticleOtoNexus Medical Technologies at the Forefront of Providing Infection Control Solution see more
SEATTLE, Oct. 1, 2020 /PRNewswire/ -- OtoNexus Medical Technologies Inc. announced today that MedTech Outlook selected them as one of 10 companies nationwide that are at the forefront of providing infection control solutions and having an impact on the industry.
OtoNexus has developed the world's first ultrasound hand-held device to evaluate the four disease states of middle ear infection. With the tools available today, detection accuracy is approximately 50% in the critical differentiation of viral versus bacterial infections. As a result, middle ear infections are the #1 reason for antibiotic prescriptions and #1 reason for surgery in children.
The Center for Disease Control suggests prescribing antibiotics for about 15% of middle ear infections. However, antibiotics are prescribed nearly 85% of the time. "Our goal is to decrease the usage of antibiotic therapy by 50% for the treatment of middle ear infections," said Caitlin Cameron, CEO OtoNexus Medical Technologies. It is an honor that MedTech Outlook recognizes how our unique technology empowers physicians to avoid unnecessary prescriptions of antibiotics and improve treatment of middle ear infections."
The OtoNexus device has the potential to:
- Minimize the use of unnecessary antibiotics in the treatment of middle ear infections
- Improve patient outcomes with timely, accurate diagnosis and treatment
- Reduce the cost of care by decreasing the number of follow up visits due to adverse antibiotics side effects and referrals to specialists
"We have been quite impressed by OtoNexus Medical Technologies' expertise in providing infection control solutions," said Alex D' Souza, Managing Editor of MedTech Outlook magazine." We congratulate OtoNexus Medical Technologies on this prestigious recognition and look forward to seeing their impressive growth streak continue."
About OtoNexus Medical Technologies Inc.
OtoNexus has developed the world's first hand-held medical device with miniaturized ultrasound technology to instantly and accurately diagnose middle ear infections. In less than 2 seconds, physicians can evaluate middle ear infections and know whether antibiotic therapy is appropriate. This definitive test will provide physicians the information they need to minimize the use of antibiotics, improve patient outcomes, and reduce the cost of care. For more information, please visit www.otonexus.com
About MedTech Outlook
MedTech Outlook is a platform that bridges the spectrum between MedTech Technology providers and healthcare facilities and medical institutions. MedTech Outlook monitors and informs about MedTech trends, challenges, and solutions. MedTech Outlook assists purchasers/procurers, decision-makers, and heads of operations, healthcare managers from peer vetted authoritative contributions.
About Keiretsu Forum
Keiretsu Forum, the world’s leading angel investor network with over 1,500 investors in 38 chapters on 3 continents. Keiretsu Forum has invested more than $500 million into more than 700 companies since inception. Keiretsu Capital administers funds on behalf of its Limited Partners - the Co-Investment & Opportunities Fund creates a diversified portfolio of technology start-ups backed by top tier angel groups and pursues the high upside value potential in these dynamic investment opportunities while promoting the sharing of risk inherent in any early-stage venture. The firm is based in Seattle and San Francisco and its principals are veteran Silicon Valley and technology investors Randy Williams, Matthew C. Le Merle, and Nathan McDonald.
For more information please visit www.keiretsuforum.com or contact us.