FDA
Less than 1 min.Read

eCential Robotics Receives FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device

eCential Robotics is proud to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an innovative Spine Navigation and Robotic-Assistance Device. This device provides a new, advanced solution for planning and instrumenting spinal fusion procedures.

This spine robot was developed by eCential Robotics in the framework of a collaboration with DePuy Synthes (DPS), The Orthopaedics Company of Johnson & Johnson. DPS will leverage its extensive reach and expertise to bring this innovative solution to market.

This milestone achievement highlights eCential Robotics’ unique expertise in the field of surgical navigation and robotics, reaffirming its dedication to supporting and advancing the healthcare system.

“This additional FDA clearance is a testament to our relentless pursuit of innovation and excellence in the field of surgical robotics and navigation,” said Clément Vidal, CEO at eCential Robotics. “We look forward to continuing to deliver cutting-edge solutions that enhance surgical precision and patient outcomes.”

eCential Robotics will now continue to focus on developing the commercial activities of its unique Open eCential Platform in the U.S. and partnering with implant manufacturers and tech companies to expand the range of Applications available on the Platform.

SourceeCential Robotics

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

0
Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

0
Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

0
Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

0
The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

0
“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”

About us

Medical Device News Magazine

Welcome to Medical Device News Magazine, a digital publication providing up to the minute medical device news and biotechnology news.

Need to know more?

Contact us

Navigation

Florida, New York
United States
Phone Number: 1.561.316.3330