Social Media Ideas for Fda 510(K)

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

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...

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.

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/...

CMS, FDA Propose RAPID Pathway for Medicare Coverage of Certain Medical Devices

Key Takeaways The proposed RAPID pathway would create a new voluntary CMS/FDA process for certain innovative medical devices, with the stated goals of expediting Medicare coverage...

FDA Seeks Public Feedback on Regulatory Approach for Generative AI-Enabled Medical Devices

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...

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...

<![CDATA[FDA Grants Emergency Use Authorization for Seegene’s Multiplex PCR Assay ]]>

<![CDATA[What Moments in FDA’s Review Process Should Patients and Providers be Watching Closely?]]>

FDA’s Expedited IND Pilot Comes Into Focus

By Sarah Wicks —

FDA and SEC Compare Notes: What the New MOU Means for FDA-Regulated Public Companies

By Sarah Wicks & Deborah L. Livornese & Michelle L. Butler —

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...

FDA Proposes Mandatory GRAS Notifications for Ingredients Introduced to U.S. Food Supply

Importantly, the proposal would not establish a premarket review and approval process for GRAS substances. Companies could still independently conclude that a substance is GRAS and...

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.

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.

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

A Sensor for Every Symptom: FDA Puts $1.1 Million Behind Digital Health in Drug Trials

By Mary Bass & Jennifer D. Newberger —

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 asks for feedback on AI regulation concept

The FDA is seeking feedback on a potential way of regulating medical devices equipped with generative AI features, informed by the process of training human clinicians.Described as...

HHS Proposes Reforms to the “Generally Recognized As Safe” Pathway

On August 10, 2026, Department of Health and Human Services (HHS) Secretary Robert Kennedy made two major announcements related to the...

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...

When the Label Lags the Science: Using 505(o)(4) to Compel Labeling Changes

By Sara W. Koblitz —