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Monday, September 27, 2021

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Nanox to Announce Zebra Medical Vision Secures 8th 510K FDA Clearance for its Coronary Artery Calcium (CAC) Solution as Part of Its Population Health...

On August 10th, 2021 Nanox announced that it had entered into an acquisition agreement via merger with Zebra Medical Vision LTD.

NGMedical GmbH Receives FDA Clearance for Its AM Titanium Lumbar Interbody BEE® PLIF

The BEE® PLIF cage has been created to benefit from additive manufacturing features. The purposefully designed honeycomb endplate design reduces the risk of subsidence, while allowing fusion.

Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System

The system maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning, and grafting process for TLIF and PLIF spinal fusion procedures.

Zebra Medical Vision Secures 8th FDA Clearance for its Coronary Artery Calcium Solution as Part of Its Population Health Offering

The CAC solution will empower clinicians to report findings and recommend preventative treatments before a coronary event occurs, subsequently saving lives while lowering costs for the healthcare systems.

Gynesonics Announces FDA Clearance of Next Generation Sonata System

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.

FDA Will Follow The Science On COVID-19 Vaccines For Young Children

As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents...

FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products...

As required by statute, a key consideration in their review of premarket tobacco product applications submitted for products like e-cigarettes is to determine whether permitting the marketing of the product would be "appropriate for the protection of the public health," taking into account the risks and benefits to the population as a whole.

Intelivation Technologies received FDA approval for the Advantage-C™ PEEK Cervical Interbody Fusion device

President Amit Sinha stated, "I am excited about the FDA Approval of Advantage-C™ and the myriad of efficiencies this device will bring to both surgeons and hospital systems alike."

NeuroOne® Medical Technologies Corporation Receives FDA 510(k) Clearance for its Evo® sEEG Electrode

"This represents yet another critical milestone met by the Company as we continue to execute our strategy.  The next steps for the Company are to expand the sEEG labeling for longer term use, which we believe will be a key part of our commercialization strategy for the Evo sEEG electrode, and complete development of an sEEG ablation electrode/probe for ablation of brain tissue and permanently implanted stimulation electrodes for patients with chronic applications such as epilepsy, Parkinson's disease and chronic back pain," said Dave Rosa, CEO of NeuroOne.

EndoSound Vision Ultrasound System Receives FDA Breakthrough Device Designation

“The Breakthrough Device Designation is evidence of the transformative potential the EndoSound Vision System presents,” stated Dr. Stephen Steinberg, MD, EndoSound Founder, and President.

Intelivation Technologies Received FDA Approval for the Golden Isles Pedicle Screw System™

President Amit Sinha remarked, "The modularity of the Golden Isles Pedicle Screw System™ enables the surgeon greater versatility, efficiency, and visibility to achieve superior patient outcomes for the most difficult degenerative and traumatic procedures."

Prelivia, a Neurostimulation Device Receives 510k FDA Clearance

The U.S. Food and Drug Administration has provided 510 (k) Clearance for Prelivia, a neurostimulation device developed by Rehabtronics that promotes healthy blood circulation...

Impella ECP Receives FDA Grants Breakthrough Device Designation

The designation means the FDA will prioritize Impella ECP’s regulatory review processes including design iterations, clinical study protocols and pre-market approval (PMA) application.

FDA Conditionally Grants Occlutech an IDE for PFO Study in U.S.

Patient enrollment is expected to commence during the second half of 2021. The study's primary and secondary endpoints, PFO Closure and recurrent stroke, respectively, will be evaluated at the 12-month patient follow-up.

FDA Approves New Treatment for Pompe Disease

"Pompe disease is a rare genetic disease that causes premature death and has a debilitating effect on people's lives," said Janet Maynard, M.D., deputy director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA's Center for Drug Evaluation and Research. "Today's approval brings patients with Pompe disease another enzyme replacement therapy option for this rare disease. 

remedē EL-X System System FDA Approval

"The next-generation remedē System is built on the proven success of the current platform, with the needs of both patients and clinicians in mind," said Pete Sommerness, President of ZOLL Respicardia.

FDA Warns Firm with Over 15 Million Products Listed with FDA to Remove Unauthorized E-Cigarette Products from Market

Visible Vapors LLC, based in Pennsylvania that manufactures and operates a website selling electronic nicotine delivery system (ENDS) products, including e-cigarettes and e-liquids, received a warning letter from the FDA advising them that marketing these new tobacco products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S.

AnchorDx’s Non-invasive Bladder Cancer Early Detection Test, UriFind, Earns “Breakthrough Device Designation” from FDA

Compared with the traditional gold standard cystoscopy for bladder cancer detection, UriFind is non-invasive, painless, and easy to operate allowing for the accurate detection of bladder cancer by simply collecting random urine, providing the Test and conducting methylation detection of exfoliated cell DNA in urine.

FDA Grants Breakthrough Designation to Synapse Biomedical’s TransAeris® System

"The Breakthrough Device designation for our TransAeris temporary diaphragm stimulation system is built upon our 20-year experience with NeuRx diaphragm pacing," said Anthony Ignagni, President & CEO of Synapse Biomedical.
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