Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 126: Josh Arant, COO, Mako Medical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
Over the last several years, State and Federal legislatures across the country have proposed and adopted laws that will transform and hinder the entire manufacturing industry. The various right-to-repair laws gaining traction...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more
The revised provisions provide medical device and in-vitro diagnostics manufacturers with additional time to bring their product into compliance with the new EU Regulations, subject to a number of conditions. On March 20,...more
Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more
In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more
Last week, on 23-25 June 2020, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) updated the responses to six of the Frequently Asked Questions related to laboratories and...more
Right to repair laws have come in and out of the public eye over the last decade. While many of the earliest laws covered only specific industries, such as the automotive and farm equipment industries, many states are looking...more
The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more
Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more
In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more