Alpha Tau Completes Patient Enrollment in its U.S. Pivotal Skin Cancer Study, Advancing Towards Goal of FDA Approval of Alpha DaRT® to Treat Recurrent Cutaneous Squamous Cell ...

First U.S. pivotal study for Alpha Tau to have completed enrollment, representing a critical milestone on the path towards potential FDA ...
Seeking Alpha

United Health Products Provides Update on FDA PMA Application Process

Mesquite, NV, March 29, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products, Inc. (UEEC) today provided an update on the company’s FDA Premarket Approval application process. As ...
Regulatory Affairs Professionals Society

FDA cites firms for CGMP violations, failure to submit PMA application

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...

Practical Guide to FDA Medical Device Submissions: 510(k), PMA and Exemption Pathways (WEBINAR)

The main market opportunities include navigating US regulatory pathways like 510(k), PMA, and DeNovo for medical device approvals. The modified 510(k) process encourages submission of new technologies ...
RAPS

FDA Offers New Insight on When to Submit PMA Supplements for Device Manufacturer Site Changes

Medical device companies trying to understand what officially constitutes a manufacturing site change and when to submit a premarket approval (PMA) supplement will want to consult with draft guidance ...

Implantica publishes Annual Report 2025

Implantica AG (publ), a med-tech company at the forefront of bringing advanced technology into the body, is publishing its annual report for the fiscal year 2025. The annual report is now available on ...
Seeking Alpha

United Health Products Submits Full FDA PMA Application

MOUNT LAUREL, NJ, March 21, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire-- United Health Products, Inc. (UEEC) today provided an update on the company’s FDA Premarket Approval application process. The ...
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 ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Brendan Carroll, Jessica Ritsick, Jong Ho "Philip" Won, Ph.D. Our FDA: Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...