VoxelMatters

3D Systems achieves FDA 510(k) clearance for VSP Orthopedics

D Systems achieves FDA 510(k) clearance for VSP Orthopedics - further enabling adoption in the pediatric orthopedic oncology ...
360Dx

Truvian Receives FDA 510(k) Clearance for Multimodal Benchtop Analyzer

The analyzer integrates clinical chemistries, immunoassays, and hematology assays into a single plug-and-play instrument.
Becker's ASC

CurveBeam Receives FDA 510(k) Approval for the pedCAT 3D Foot and Ankle Scanner

CurveBeam has announced it has received FDA 510(k) approval for pedCAT, an in-office 3D foot and ankle scanner, according to a news release from CurveBeam. pedCAT uses cone Beam Computed Tomography ...
Hosted on MSN

Tempus AI Enhances AI-Driven Diagnostics With Multiple FDA Approvals

In the first nine months of 2025, Tempus AI Inc. TEM achieved several key regulatory milestones that strengthened its position in AI-driven diagnostics. In September 2025, the company received FDA 510 ...
Becker's ASC

Ophthalmic Laser Company Lumenis Receives FDA 510(k) Approval

Lumenis, an Israel-based medical laser company for ophthalmic and surgical applications, received FDA 510(k) clearance for the ResurFX, a fractional non-ablative laser module. The ResurFX is part of ...

Ceribell Receives FDA 510(k) Clearance for First-of-its-Kind Delirium Monitoring Solution

(Nasdaq: CBLL) (“Ceribell”), a medical technology company focused on transforming the diagnosis and management of patients ...

SS Innovations Submits 510(k) Premarket Notification to the FDA for the Company’s SSi Mantra Surgical Robotic System

Submission covers multiple indications including general, urological, colorectal, gynecological and cardiac surgeries --FORT LAUDERDALE, Fla., ...
Business Wire

Neurescue's Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest

COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S.
MarketWatch

Intro to Medical Device Submission Virtual Course: Navigating FDA Pathways - 510(k), IDE, De Novo, and PMA Requirements for Medical Device Approval in the U.S. (Oct 9, 2025 ...

The "Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions (Oct 9, 2025)" training has been added to ResearchAndMarkets.com's offering. The regulation and control of new or substantially ...