Are Expectations of a 501K Approval Perking Up?
We’ve learned through trial and error (with the better lessons coming from error) not to keep our hopes up too much with anything related to the FDA. Not to say we don’t venture into pre-approval ideas. We live in the pre-approval space.
January 6th, 2021: Adding ENDRA Life Sciences (NDRA) $0.89 to Watch List.
“FDA has targets for how long it should take to make a decision: 90 days for a traditional 510(k) submission, 60 days for an abbreviated 510(k) submission and 30 days for a special 510(k) submission. The beginning of the process is the same for all three types of submissions.” Read more from Medical Device Group.
Here’s the last bit of news related to their submission.
ENDRA Life Sciences Submits 510(k) Application to the US FDA for TAEUS(R) Liver Device.
Regulatory submission marks another major step toward commercialization of TAEUS liver device in 2020
ANN ARBOR, MI / ACCESSWIRE / June 30, 2020 / ENDRA Life Sciences Inc. (“ENDRA”) (NASDAQ:NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUSⓇ), today announced the 510(k) Premarket Notification submission to the U.S. Food and Drug Administration (“FDA”) for its TAEUS Fatty Liver Imaging Probe (“FLIP”).
“Despite an unprecedented global COVID-19 environment, with widespread disruptions in business and healthcare operations, the small ENDRA team has achieved remarkable milestones in the first half of 2020, including receipt of the European CE regulatory mark, the addition of a third U.S. clinical evaluation site, growth of ENDRA’s IP portfolio to 72 assets, and now the submission of our 510(k),” said Francois Michelon, ENDRA’s chairman and chief executive officer.
“Our 510(k) submission is the culmination of years of scientific research, quality system implementation, clinical data collection, and biocompatibility and safety testing, and I’m very proud of the ENDRA team. We look forward to working with the FDA throughout the review process to achieve our goal of an FDA clearance allowing for commercialization in the U.S. this year,” concluded Michelon.
While the FDA conducts its regulatory review, which typically takes several months, the ENDRA team will focus on executing key components of its European commercialization plan, including establishing clinical evaluation reference sites and initiating sales in the second half of the year.
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology being developed to visualize tissue like an MRI, but at 1/50th of the cost, at the point of patient care. TAEUS is designed to work in concert with existing ultrasound systems. TAEUS is initially focused on the measurement of fat in the liver, as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and inflammation (NASH), chronic liver conditions that affect over 1 billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS, including visualization of tissue temperature during energy-based surgical procedures. www.endrainc.com
All statements in this release that are not based on historical fact are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate” or other comparable terms. Examples of forward-looking statements include, among others, statements we make regarding expectations regarding the commercialization and sales of our TAEUS device in European jurisdictions, obtaining U.S. 510(k) regulatory approval for our TAEUS device and the timing of any such approval; plans relating to our supply chain and clinical studies of the TAEUS device, including its adoption by clinicians; and expectations concerning ENDRA’s product development and business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, the following: our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals; the impact of the COVID-19 pandemic on our business strategy; our ability to find and maintain development partners, market acceptance of our technology, the amount and nature of competition in our industry; our ability to protect our intellectual property; and the other risks and uncertainties described in ENDRA’s filings with the Securities and Exchange Commission. The forward-looking statements made in this release speak only as of the date of this release, and ENDRA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.
Chief Financial Officer