CMS now covers Clarify's phototherapy psoriasis treatment

USA – CMS now covers Clarify’s phototherapy psoriasis treatment

Clarify Medical said today that it won reimbursement coverage through the U.S. Centers for Medicare & Medicaid Services for treatments with its Clarify Home light...
US FDA Updates UDI Policy for Direct Marking of Medical Devices

USA – US FDA Updates UDI Policy for Direct Marking of Medical Devices

EMERGO SUMMARY OF KEY POINTS: US FDA has revised UDI direct marking requirements and deadlines for some non-sterile, Class I and unclassified medical devices. ...
What Will 2019 Bring for Medtech?

USA – What Will 2019 Bring for Medtech?

Healthcare is definitely changing, evident from several developments in 2018. While payers and providers have been working for some time to improve healthcare quality...
CDRH Qualifies 3rd Medical Device Development Tool

USA – CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions

The US Food and Drug Administration (FDA) on Monday published final guidance on the FD&C Act’s least burdensome provisions for the regulation of medical devices, highlighting...
Bipartisan Bill would allow Drug Imports from Canada

Canada – Canada’s MDSAP Transition Deadline Fast Approaching

EMERGO BY UL SUMMARY OF KEY POINTS: Health Canada’s December 31, 2018 deadline for MDSAP transition imminent. Medical Device License (MDL) holders for Class...
Updated: FDA Warns Zimmer Biomet’s Indiana Plant

USA – Updated: FDA Warns Zimmer Biomet’s Indiana Plant

Zimmer Biomet announced Friday via an SEC filing that it received a warning letter related to observed non-conformities with current good manufacturing practice (CGMP) requirements of...
Medical device industry regulation is changing: What you need to know

USA – Medical device industry regulation is changing: What you need to know

The medical device industry has been taking a lot of heat lately when it comes to patient safety. There’s the recent International Consortium of Investigative Journalists’ “Implant...
New Hip Replacement Procedure Launches

USA – New Hip Replacement Procedure Launches

The first two total hip replacement surgeries using a new 3D technology were recently performed by Gregory Martin, MD, founder of Personalized Orthopedics of...
Publication de la norme ISO 11930:2019 sur l'évaluation de la protection antimicrobienne d'un produit cosmétique

USA – ISO Preps for FDA’s Proposed Overhaul of Device Quality System Regulation

A recently proposed US Food and Drug Administration (FDA) rule for harmonizing medical device quality management systems with ISO 13485 is “an important next...
UK's NICE recommends Procept's robotic system for BPH

UK – UK’s NICE recommends Procept’s robotic system for BPH

Procept BioRobotics said today that it won an Interventional Procedure Guidance recommendation from the UK’s National Institute for Health and Clinical Excellence for is Aquablation...

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