Search results for Fda-Cleared

Zeto’s latest EEG device garners FDA 510(k) clearance for outpatient use

Zeto, which makes brainwave monitors for emergency rooms, received a third FDA clearance for an EEG device. The latest is intended for use in outpatient clinics or at home.

Orthopedic Driven Imaging Announces FDA 510(k) Clearance for HipGuide™ — Its First FDA-Cleared Surgical Imaging App

<![CDATA[FDA Clears Investigational New Drug Application for Phase Ib/IIa Trial of CK0802 in Steroid-Refractory Graft...

FDA Grants 510(k) Clearance for Glooko’s EndoTool IV Cloud Insulin Dosing Platform

What You Should Know Glooko has received U.S. FDA 510(k) clearance for EndoTool IV Cloud, making it the first cloud-based, patient-specific insulin dosing platform cleared for hosp...

FX Shoulder Solutions, Inc. Receives FDA 510(k) Clearance for FX V135® Easytech Shoulder System

Kreate Medical Announces Two FDA 510(k) Clearances, Introducing Antibacterial Absorbable Synthetic Matrix for Wound Mana...

Kreate Medical has received two FDA 510(k) clearances for its innovative wound matrix products, including Antibacterial Absorbable Synthetic Matrix and Absorbable Synthetic Matrix....

FDA-cleared. Quietly adopted. Nationally ready. KeyLiftâ„¢ is about to get loud.

GE HealthCare Receives FDA Clearance for True Definition DL CT Image Reconstruction Technology

What You Should Know The Regulatory Win: GE HealthCare has received 510(k) clearance from the FDA for True Definition DL, the latest addition to its portfolio of deep learning (DL)...

CMS, FDA announce pathway to expedite access to certain medical devices for Medicare beneficiaries

The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to expedite access to certain FDA-designated Class II and...

NovoSource Receives FDA Clearance for SteriKneeâ„¢ Single-Use Total Knee Instrument System

Protaryx Receives FDA Approval for Transseptal Puncture Device

Protaryx Medical, a Maryland-based company dedicated to “minimally invasive left-heart interventional therapies,” announced that its Transseptal Puncture Device received 510(k) cle...

<![CDATA[FDA Approves Foundayo Under National Priority Voucher Program]]>

World's First | Mabwell's 9MW5211 Receives FDA Clearance for Clinical Trial Application

SHANGHAI, May 8, 2026 /PRNewswire/ -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the Inves...

FDA Clears Tandem Control-IQ+ for Type 1 Diabetes During Pregnancy: First AID System to Earn Indication

What You Should Know The FDA has cleared Tandem’s Control-IQ+ technology for use in pregnancies complicated by type 1 diabetes, making it the first and only commercially available...

<![CDATA[FDA Extends Priority Review of Leqembi Iqlik Subcutaneous Injection ]]>

FX Shoulder Solutions, Inc. Receives FDA 510(k) Clearance for FX V135® Easytech Shoulder System

The Next Generation of Stemless Has Arrived ADDISON, Texas, May 5, 2026 /PRNewswire/ — FX Shoulder Solutions, Inc. has received…

Apple’s monitor cleared for radiology by FDA

Apple’s Studio Display XDR is taking an unexpected but very serious step into hospitals and radiology practices, with Apple confirming that its Medical Imaging Calibrator feature h...

FDA Grants De Novo Classification to TytoCare’s AI Otoscopy Tool

The AI-driven software analyzes otoscopy videos to detect eardrum bulging, establishing a new regulatory category for ENT diagnostic aids.

Avatar Medical Receives FDA 510(k) Clearance for Avatar Medical Vision, the First Software Cleared for Use with Glasses-...

FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

WEDNESDAY, April 29, 2026 — The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials. The move could soon...

FDA proposes rule to fast-track oral fluid and hair drug testing

The FDA moves to eliminate the 510(k) hurdle for oral fluid drug testing, a major win for the ATA and safety-sensitive industries...

FDA identifies recall of catheter kits, Early Alert for sterile labels

The Food and Drug Administration has identified a nationwide recall. Arrow International is recommending dialysis catheter kits containing Merit Medical 16F Dual-Valved Splittable...

FDA Grants De Novo Clearance to Burn Wound Assessment System

The AI-based imaging system is designed to help clinicians assess burn wound healing potential and identify wounds that may require intervention.

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