Search results for Fda Clearance

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

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...

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

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.

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

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...

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…

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)...

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

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

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

FDA Approves Expanded Clinical Applications for SINEFIXâ„¢ in Soft Tissue Repair

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

SurGenTec Secures FDA Clearance for ION-C™ – Now Navigation Compatible

SurGenTec, LLC today announced that the FDA has granted 510(k) clearance for its ION-Câ„¢ navigation instruments for use with the ION-Câ„¢ posterior cervical facet fixation implant...

Allevion Medical™ Receives 510K Clearance for Vantage™— A Fully Disposable Kit Featuring a Novel Approach to Spina...

BOCA RATON, Fla., April 3, 2026 -(BUSINESS WIRE)- Allevion Medical today announced the FDA clearance of Vantage™, a…

CMS and FDA Announce New RAPID Program for Medicare Coverage of Breakthrough Medical Devices

On April 23, 2026, the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly announced the Regulatory Alignment for Predictable and Imme...

Spectrum Spine Inc Earns FDA Clearance for Next Generation Nanotechnology – BioBraille™

SurGenTec Secures FDA 510(k) Clearance for TiLinkв„ў SI joint fusion- Now Navigation Compatible

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...

Apple’s Studio Display XDR gets medical imaging clearance from the FDA

Macworld Apple has shared news that the Studio Display XDR‘s medical imaging calibrator has received clearance from the FDA. The company’s 501(k) application has been approve...

CarboFix Spine Announces FDA Clearance of CarboClearВ® Hybrid Posterior Cervical Screw System

CarboFix Spine announced U.S. FDA clearance of the CarboClearВ® Hybrid Posterior Cervical Screw System, for the complex demands of cervical and upper thoracic spine surgery. The po...

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...

Zimmer Biomet Receives FDA Clearance for Expanded Reverse Shoulder Systems

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...