Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating

USA – Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating

Medtronic and Monteris Medical are suggesting procedural techniques to reduce unintended thermal damage linked to their magnetic resonance-guided laser interstitial thermal therapy devices, the...
UL Wades into Cybersecurity of Connected Medical Devices

USA – UL Wades into Cybersecurity of Connected Medical Devices

Safety science firm UL is honing in on the cybersecurity of connected medical devices, suggesting a two-pronged approach that spans across the total product...
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. ...
FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

USA – FDA permits marketing of two devices that detect parathyroid tissue in real-time...

Today, the U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as...
Class I and Unclassified Device UDIs: FDA Pushes Back Enforcement Dates by 2 Years

USA – Class I and Unclassified Device UDIs: FDA Pushes Back Enforcement Dates by...

he US Food and Drug Administration (FDA) released new guidance Friday that effectively pushes back by two years the date by which FDA will...
CDRH Issues Final Orders on Medical Devices for Insulin Adjustment, Drug Screening

USA – CDRH Issues Final Orders on Medical Devices for Insulin Adjustment, Drug Screening

The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued two final orders on Wednesday, classifying the...
FDA Withdraws Proposed Rule on Electronic Labeling for Certain Devices

USA – FDA Withdraws Proposed Rule on Electronic Labeling for Certain Devices

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced Wednesday that it was withdrawing a proposed rule that...
FDA isn't doing enough to prevent medical device hacking, HHS report says

USA – FDA isn’t doing enough to prevent medical device hacking, HHS report says

The US Food and Drug Administration is not doing enough to prevent medical devices such as pacemakers and insulin pumps from being hacked, a report...
US FDA Adds Details for Medical Device Conformity Assessment Accreditation Program Pilot

USA – US FDA Adds Details for Medical Device Conformity Assessment Accreditation Program Pilot

EMERGO SUMMARY OF KEY POINTS: US FDA has provided more information on its upcoming Accreditation Scheme for Conformity Assessment (ASCA) pilot program. ASCA will...
Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?

USA – Ghosts of Medtech: What Ever Happened to These 7 Medical Devices?

Sometimes even seemingly good ideas just don't pan out. Read on to see seven medtech products that once held a lot of promise but just...

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