10 Medical Devices Recently Approved by FDA

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...
FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices

USA – FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices

Under a US Food and Drug Administration (FDA) contract, a new rubric developed by the Mitre Corporation is the first-of-its-kind to be specifically tailored...
IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices

USA – IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways

The International Medical Device Regulators Forum (IMDRF) has begun wading into harmonizing the premarket review process, regulatory pathways for personalized devices and cybersecurity, following...
FDA : New steps to strengthen the process of initiating voluntary recalls

USA – Zimmer Biomet Recalls 1,300 Bone Growth and Spinal Fusion Stimulators

A recall that Zimmer Biomet initiated in February has just been identified by FDA as a Class I recall, marking it the most serious...
FDA kicks off 3rd phase of OND restructuring

USA – FDA issues final guidance on devices containing animal-derived materials

FDA has issued final guidance on medical devices containing animal or animal-derived materials. The guidance supersedes the version issued in 1998 and expands...
Final FDA Q-Submission guidance includes medical device cybersecurity coverage

USA – US FDA Publishes Highly Anticipated Update to Medical Device Cybersecurity Recommendations

EMERGO SUMMARY OF KEY POINTS: US FDA updates cybersecurity guidance first issued in 2014 for medical device premarket submissions. The new guidance introduces a...
FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

USA – FDA clears mobile medical app to help those with opioid use disorder...

Today, the U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of time a patient participates)...
NESTcc Taps Apple Watch as First Wearable Project

USA – NESTcc Taps Apple Watch as First Wearable Project

The National Evaluation System for health Technology Coordinating Center’s (NESTcc) 12 new real-world evidence (RWE) test cases marked its first active surveillance project—the US...
FDA Approves First Contraceptive Mobile App

USA – FDA Approves First Contraceptive Mobile App

A Swedish startup company obtained US Food and Drug Administration (FDA) approval Friday for the country’s first mobile medical app indicated for contraceptive use. The...
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. ...

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