Social Media Ideas for Fda 510(K) Approval

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...

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.

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/...

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.

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

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.

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...

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.

<![CDATA[Pharmaceutical Executive Daily: FDA Grants Traditional Approval to Novartis's Fabhalta]]>

<![CDATA[FDA Approves Fabhalta to Slow Kidney Function Decline in Primary IgAN in Adults ]]>

Meet Aletta: The first FDA approved robotic blood draw device

The FDA has approved Vitestro’s Aletta as the first standalone robotic device in the U.S. designed to draw blood without the need for hands-on human help.

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.

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...

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...

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Simtriyo]]>

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.

The FDA just picked its first company to sell an unauthorised device to Medicare patients

The US Food and Drug Administration named Dexcom as the first manufacturer selected for its Technology-Enabled Meaningful Patient Outcomes pilot on Tuesday. The programme, known as...

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.

FDA issues red alert for US heart pump system

FDA approves Freenome colorectal cancer blood test to be marketed by Abbott

The FDA has approved Freenome’s new blood-based colorectal cancer test, SimpleScreen CRC, which Abbott will exclusively market in the U.S.

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…

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...

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Subcutaneous Formulation of Leqembi Iqlik]]>

Synergy Disc® Reaches 100 U.S. Cases in 100 Days Following FDA Approval, Advancing Motion-Preserving Cervical Disc Repla...

Following FDA approval earlier this year, U.S. surgeons are adopting the Synergy Disc ® for its motion-preserving design, 6-degree lordotic…