Social Media Ideas for Fda-Cleared Device

FDA Clears First Neurostimulation Device for PTSD

Neurovalens’ Modius Spero has become the first FDA-approved neuromodulation device for treating PTSD symptoms. Veterans are set to gain access through the VA this summer. The post...

United Therapeutics nabs FDA approval for donor-lung assessment device

United Therapeutics has been given a premarket approval from the FDA for its LungFX device.

SkinHealth Systems Expands FDA-Cleared Indications for SkinStylus Microneedling Device

The FDA has cleared the SkinStylus microneedling device for the improvement of periorbital wrinkles in adults aged 22 years and older across all Fitzpatrick skin types, expanding t...

IHealthScreen nabs FDA nod for AI-backed dx to spot mild diabetic retinopathy

IHealthScreen hauled in FDA 510(k) clearance for its AI-powered diagnostic that detects mild diabetic retinopathy in diabetic adults who have gone undiagnosed with the condition.

Shockwave for diabetic foot ulcers

FDA News Release FDA permits marketing of device to treat diabetic foot ulcers Summary FDA permits marketing of device to treat diabetic foot ulcers Release Today, the U.S. Food...

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.

Winter Innovations Receives FDA 510(k) Clearance and PCCP Authorization for Expanded EasyWhip® Family

Winter Innovations announced that the FDA has granted 510(k) clearance for the expanded EasyWhip® Family, along with authorization of a Predetermined Change Control Plan (PCCP) cov...

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...

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/...

Neuro20: Advancing Continuous Neurological Care for Veterans

FDA-cleared, non-invasive, drug-free technology now available to VA and federal healthcare providers, supported by education, demonstration, onboarding, and implementation resource...

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...

KardiaMobile – Medical-Grade FDA-Cleared 1-Lead Personal EKG Monitor

The KardiaMobile is a personal EKG monitor that records a single-lead, medical-grade electrocardiogram (EKG) right on your phone and provides an instant analysis in seconds that yo...

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

LG expands B2B medical device lineup with FDA-cleared diagnostic monitor

LG Electronics has launched a new diagnostic monitor cleared by the U.S. Food and Drug Administration (FDA) as a medical device, expanding its lineup of business-to-business (B2B)...

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...

This Ear-Based Device Could Save Patients from Brain Bleed Complications

Aurenar’s V-Link, a non-invasive nerve stimulation device for preventing brain hemorrhage complications, just won FDA breakthrough device designation after early trials showed it c...

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.

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.

Six Artis Interventional Imaging Systems Cleared by the FDA

Optiq AI addresses demand for precision and high image quality in image-guided therapy Deep-learning-based noise reduction improves quality of live images New portfolio address...

FDA Clears Ultherapy PRIME for Skin Laxity on the Knees

The FDA has cleared Merz Aesthetics’ Ultherapy PRIME to improve the appearance of skin laxity on the knees, expanding the device’s body indications.

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...

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...

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...

Samsung’s Hearing Aid Feature on Galaxy Buds Cleared by FDA

Samsung Electronics today announced that its Galaxy Buds Hearing Aid feature has received U.S. Food and Drug Administration (FDA) clearance. The feature enables compatible Galaxy B...