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First Adaptive Hemorrhagic Stroke Trial Completes Enrollment

Trial sponsor, NICO Corporation, hopes to show functional recovery for the most deadly, costly stroke INDIANAPOLIS, Oct. 6, 2022 /PRNewswire/ -- NICO Corporation announced today...

Owlet Announces FDA 510(k) Submission for Prescription Pediatric Monitor

The Company filed a 510(k) premarket notification for its prescription-only medical device to be used in-home for babies under the supervision of a physician LEHI,...
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IRRAS Announces Participation and Educational Symposium at Key Upcoming Neurosurgery Conferences

IRRAS will exhibit at the upcoming Congress of Neurological Surgeons (CNS) annual meeting in San Francisco, CA, from October 8 - 12, 2022, and...

SpineX Demonstrates Groundbreaking Technology to Treat Children with Cerebral Palsy

SpineX Publishes Results from First in Human Study Using its Proprietary Non-Surgical and Non-Invasive Device SCiP to Treat children with Cerebral Palsy LOS ANGELES--(BUSINESS WIRE)--...

MDA Updated Guidance on Establishment Licensing: Overview

The article provides an overview of the regulatory requirements in the sphere of establishment licensing and highlights the key points to be taken into...

FDA Guidance on Low-Risk Devices: Overview

The article provides an overview of the regulatory policy for low-risk medical devices.  Table of Contents The Food and Drug Administration...

HSA Guidance on Change Notification: FSCA-related Changes and Exemptions

The new article highlights the aspects related to the changes to registered medical devices implemented in response to adverse events, the context of field...

FDA Guidance on Production Software Assurance: Risk-Based Approach

The new article describes in detail the aspects related to a risk-based approach and the way it should be applied concerning computer software assurance...
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