Intelligent Bio Solutions Completes Clinical Cut-off Study, Advances FDA 510(k) Clinical Program Targeting Multi-Billion-Dollar U.S. Drug Screening Market

Study results finalized on schedule support FDA clearance and planned U.S. commercial launchCompany advances second phase of clinical program for ...
TMCnet

Zeto Announces FDA 510(k) Clearance of Zeto New Wave™, Advancing Efficiency in Outpatient EEG

The FDA clearance of the Zeto New Wave™ marks Zeto's third FDA-cleared device, alongside Zeto WR19 and Zeto ONE. Zeto offers ...

Restore Robotics Receives FDA 510(k) Clearance for Two Additional da Vinci Xi® Robotic Instruments

Restore Robotics today announced it has received additional 510(k) clearances from the U.S. Food and Drug Administration (FDA ...
MassDevice

Zeto picks up FDA clearance for outpatient EEG tech

New Wave marks the Raleigh, North Carolina-based company’s latest EEG system for outpatient clinics and homes. Zeto says it addresses the long waits for EEG appointments and shortages of EEG ...
MassDevice

Restore Robotics wins FDA nod to remanufacture new da Vinci instruments

Restore Robotics announced new FDA 510(k) clearances for the remanufacturing of two Intuitive da Vinci Xi robotic surgical ...

SoloPace Announces US Commercial Release of the SOLO PACE FUSION Temporary Pacing System Following FDA 510(k) Clearance

Solo Pace Incorporated, an emerging medical technology company, today announced the commercial release of the SoloPace FUSION(TM) Temporary Pacing System. The launch follows US Food and Drug ...
Zacks Investment Research on MSN

Philips wins FDA 510(k) clearance for AI heart valve repair solution

Koninklijke Philips PHG on Friday, March 26, announced that it has received FDA 510(k) clearance for its advanced AI-enabled ...
Healio

FDA grants 510(k) clearance to in vitro blood-based Alzheimer’s biomarker device

Please provide your email address to receive an email when new articles are posted on . Amyloid plaques are one telltale sign of Alzheimer’s disease pathology in blood plasma. A blood-based diagnostic ...
National Academies of Sciences%2c Engineering%2c and Medicine

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

To gain a foundation on which to build its discussions, the committee commissioned two former Center for Devices and Radiological Health (CDRH) staff to draft a background paper on the 510(k) or ...

Restore Robotics Receives FDA 510(k) Clearance for Two Additional da Vinci Xi(R) Robotic Instruments

Restore Robotics today announced it has received additional 510(k) clearances from the U.S. Food and Drug Administration (FDA) for the remanufacturing of two more da Vinci Xi(R) robotic surgical ...