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Latest News & Client Successes

Spineex Saggitae 510(k) Cleared In 33 Days


Empirical Technologies Corp. is proud to announce the 510(k) clearance of Sagittae® by SpineEx, Inc. in just 33 days!

We love to share our client's success with the world and SpineEx, Inc. continues to be a valued partner.Huge thanks to our Empirical Team members: Meredith May, Nathan Wright, and Susan Holmes for their great teamwork.

Here is what Andrew Rogers of SpineEx, Inc. had to say about our Team:

"The Empirical Team has once again proven instrumental to our business and RA/QA efforts by assisting us with yet another successful 510(k) submission and clearance!"

Read more about Sagittae® Here

For more information about Sagittae®, please contact your SpineEX representative, or email:

SpineEX, Inc.
4046 Clipper Court
Fremont, CA 94538 USA


Due to COVID-19, thousands of orthopedic patients have experienced a sudden cancellation of scheduled hip, knee, shoulder, extremity, and spine surgeries, as well as physical therapy sessions. These patients will be forced to endure their pain and limited mobility for an indefinite amount of time. Surgeons, physical therapists and engineers in the orthopedic community are challenging themselves and the public to rapidly deliver innovative products, services, and software that can bring relief.
NovApproach Spine’s CEO, Raymond Cloutier, is sponsoring the For Such A Time As This—OrthoChallenge to help expedite introduction of new product, software, and services that address the needs of orthopedic patients whose surgeries and therapies are delayed. The top 10 ideas will be presented to the Food & Drug Administration and other government leaders to help “fast track” these innovations to patients.
The new product, software, or service ideas will help orthopedic patients with their pain and limitations while they wait for surgery and reduce the COVID-19 risks unique to orthopedic patients.

Full Press Release: PRESS RELEASE-ForSuchATImeAsThis-Ortho-Public 8Apr2020 FINAL

Submissions may be submitted digitally at during the month of April and the top 10 will be announced in May.

510(k) Submissions

Empirical Technologies Corp. is proud to be the leader in submitting 510(k)s for our clients. The Empirical name is on more FDA cleared 510(k) submissions than any other regulatory consulting company. More than 67% of our submissions are accepted without RTA with an average of 106 days to clearance. Recently, we have had submissions clear in as little as 57 days! 

Empirical is also leading the way to assist with COVID-19 related submissions. Contact us about your next project and let us help you get it cleared FAST.

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Upcoming Events

We Are Exhibiting! Booth #1236

Empirical Technologies Corp. is excited to exhibit again at the 36th Annual Space Symposium in Colorado Springs, CO. The event has been rescheduled for
Oct. 31 to Nov. 2, 2020 at The Broadmoor Hotel.
Contact to set up an appointment at our booth.

Dawn Lissy

Speaking at OSMA

Empirical's President and Founder will be speaking at OSMA's virtual Spring 2020 Meeting Apr. 29-30.