Social Media Ideas for Fda 510(K) Clearance

Candelis Announces FDA 510(k) Clearance for ImageGrid® StreamVue™ Enterprise Diagnostic Streaming Viewer

Delivering premium diagnostic performance from any location without the cost and disruption of traditional enterprise viewing platforms. NEW YORK, July 30, 2026 /PRNewswire-PRWeb/...

SurGenTec® Secures FDA Clearance for ION-L™ – Lumbar Navigation Compatible

SurGenTecВ® announced that the FDA has granted 510(k) clearance for its ION-Lв„ў navigation instruments for use with the ION-Lв„ў Lumbar Facet Fixation System.

<![CDATA[FDA Clears Consano’s IND for C-1101 ]]>

GMReis Receives FDA 510(k) Clearance for the VersaLock® Sterile Plating System, Advancing Its Single-Use Trauma Strategy...

GMReis has received FDA 510(k) clearance K262537 for the VersaLock® Sterile Plating System, completing 510(k)-cleared sterile implant solutions across its upper and lower extremity...

3D Systems Enables First FDA Clearance for Implant from a Point-of-Care Institution

- Collaboration with Defense Health Agency (DHA) enables Walter Reed 3D Medical Application Center (3D MAC) to achieve first FDA-cleared medical device - First-ever FDA clearance...

FDA Eases Approval Path for Certain Cancer Companion Diagnostic Tests

The U.S. Food and Drug Administration has issued a final order moving certain laboratory tests used to help guide treatment with approved cancer drugs from...

Elevation Spine Receives FDA 510(k) Clearance for Saber-CВ® AVIAв„ў, A Complete Anterior Cervical Fixation System with a...

Elevation Spine today announced that the (FDA has granted 510(k) Clearance for Saber-CВ® AVIAв„ў.

Spineart and eCential Robotics receive FDA 510(k) clearance for the PERLA® TL application for use with eCential® Op.n® n...

GENEVA, Aug. 26, 2026 /PRNewswire/ — Spineart, a global fast-growing company in spine surgery innovation, and eCential Robotics today announced…

MAMMOMAT B.brilliant Contrast-Enhanced Mammography Cleared by the FDA

• Improved image reconstruction supports diagnosis even in dense breast tissue• Contrast-enhanced biopsy boosts diagnostic confidence• Features build on system's ability to create...

ArthroTAK Receives FDA 510(k) Clearance for Expanded Indications, Extending Sutureless Fixation Platform Across the Body

ArthroTAK, LLC has received FDA 510(k) clearance for expanded indications, extending the ArthroTAK® platform beyond its original shoulder applications into new areas of the body, i...

Provect AI Secures FDA Clearance for Software that Converts Standard C-Arm X-Rays into Intraoperative 3D Imaging for Spi...

Provect has received U.S. FDA 510(k) clearance for its software platform that converts standard C-arm X-rays into CT-like 3D images during spine and orthopedic procedures—without r...

Laser Marking Technologies, LLC Announces FDA-Compliant UDI Marking Solutions for Medical Device Manufacturers Navigatin...

A new FDA inspection standard is making Unique Device Identification marking accuracy an actively enforced requirement, and Laser Marking Technologies, LLC offers cost-conscious la...

SurGenTec® Secures FDA Clearance for ION-L™ – Lumbar Navigation Compatible

BOCA RATON, Fla., July 24, 2026 /OrthoSpineNews/ – SurGenTec®, a medical device company focused on advancing treatment options…

Abbott garners FDA nod for its TactiFlex catheter to treat AFib

Abbot received FDA clearance for its latest-generation catheter that allows physicians more flexibility when treating atrial fibrillation in patients.

Bioretec receives FDA 510(k) clearance for its ActivaScrewâ„¢ Cannulated COM bioabsorbable compression screw

September 8, 2026 – Bioretec Ltd (“Bioretec” or the “Company”), a pioneer in bioabsorbable orthopedic implants, has received…

FDA greenlights Abbott’s wearable sensor for capturing diabetic ketoacidosis

The FDA has approved Abbott’s first-of-its-kind bio-wearable sensor that can warn diabetics of increased ketones that can lead to diabetic ketoacidosis.

FDA clears Johnson & Johnson’s surgical robot for ‘the next era in surgery’

The FDA has authorized Johnson & Johnson’s Ottava Robotic Surgical System as the company looks to compete with Intuitive Surgical and Medtronic.

Samsung hearing aid features for its ear buds garner FDA clearance

The FDA gave Samsung Electronics the go-ahead for the latest software features that allow its Galaxy Buds earphones to act as an OTC hearing aid that also allows users to diagnose...

Implantica finally nabs FDA approval 8 years after EU green light for reflux implant

The FDA has signed off on Implantica’s gastroesophageal reflux disease (GERD) implant as the medtech eyes a lucrative U.S. market.

Modular Medical Announces FDA Clearance of Pivot Tubeless Insulin Patch Pump Enhancements

Clearance Covers Software Enhancements for Greater Patient Flexibility and Pivot Customization

Smith+Nephew’s TESSA™ Spatial Surgery System granted De Novo classification by the FDA sparking a generational leap in S...

Smith+Nephew announces it has been granted De Novo classification by the U.S. Food & Drug Administration (FDA) for its TESSA Spatial Surgery System.

How CMS Is Tackling ‘Coverage Purgatory’ for Medical Devices

CMS unveiled new details of its new RAPID pathway, which is designed to close the gap between FDA approval and Medicare coverage for breakthrough medical devices. Industry reaction...

FDA Formally Classifies Active Noise Attenuation Systems for Infant Incubators as Class II Devices

The regulatory action clears a pathway for future manufacturers to bring noise-canceling incubator systems to market through a less burdensome route.

Wandercraft Receives FDA Clearance for Eve, the World’s First Self-Balancing Personal Exoskeleton, for Eligible Wheelcha...