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Four Year Follow-Up Data from Profound Medical’s TACT Pivotal Clinical Trial Confirm Durable and Stable Positive Trends Following Treatment with TULSA-PRO® of Men with...

TORONTO, Sept. 26, 2022 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and...

BD, CerTest Biotec Announce US Commercial Launch of Monkeypox Assay

Research Use Only (RUO) assay now globally available for BD MAX™ System FRANKLIN LAKES, N.J., Sept. 26, 2022 /PRNewswire/ -- BD (Becton, Dickinson and...

FDA Guidance on Monkeypox Tests: Specific Aspects

The present article provides additional details regarding specific aspects related to the policy for monkeypox tests, including the ones related to validation, serology tests,...

TGA Guidance on Clinical Evidence: Comparable Devices

The new article describes in detail the approach to be applied concerning comparable devices including substantially equivalent devices.  Table of Contents ...

FDA Guidance on the Least Burdensome Approach: Streamlining the Process

The new article describes the particular way the least burdensome provisions should be applied to facilitate and streamline the regulatory processes associated with placing...
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EU Manual on Borderline and Classification for Medical Devices: Overview

The new article provides an overview of the medical device classification rules adopted in the European Union and highlights the key points associated thereto.  ...

FDA Guidance on Monkeypox Tests: Modifications, Notification Content, and Reporting

The present article describes in detail the aspects related to modifications to tests already approved for use in the US, as well as the...

HSA Guidance on GDP: Internal Audits and Outsourcing

The article highlights the key points related to internal audits and outsourcing activities.  Table of Contents The Health Sciences Authority (HSA),...

FDA Guidance on the Least Burdensome Approach: Clinical Studies and Benefit-Risk Assessments

The new article describes in detail the means for reducing the burden of traditional clinical studies, and also the use of benefit-risk assessments.  ...

Moximed reports data from MISHA Knee System study

Medical device company Moximed has reported data from the pivotal Calypso Study of its MISHA Knee System. An implanted shock absorber (ISA), the MISHA Knee...

The medical industry found it easier to fill digital media vacancies in Q2 2022

Digital media related jobs that were closed during Q2 2022 had been online for an average of 30.6 days when they were taken offline. This...
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