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In the face of increasing cybersecurity threats, the Biden administration is taking several measures to implement stronger cybersecurity standards, including requiring software developers to maintain greater visibility in their supply chains and make security data publicly available. Read More
The European Commission has launched an online helpdesk for devicemakers who must comply with the new unique device identification (UDI) system introduced under the EU Medical Device Regulation (MDR), which went into effect on May 26. Read More
Validation issues, design control and inadequate corrective and preventive procedures were among the quality system failures cited in a warning letter to Wheat Ridge, Colorado-based DeChoker following a Feb. 17-26 FDA inspection. Read More
The FDA details its expectations for postmarket surveillance of moderate and high-risk devices in two draft guidances, including its criteria for ordering postmarket data collection. Read More
The FDA has studied how South Korea handled authorizations of COVID-19 diagnostic tests, hoping to learn from that country’s early success in dealing with the virus. Read More
They are used to precisely align the patient’s spine and treat scoliosis, trauma, tumors and complex degenerative conditions in adults, as well as idiopathic scoliosis in adolescents. Read More
The system, which currently can only be used for research purposes in the U.S., is designed to detect and grade prostate and breast cancer tumors. Read More
The company has received six FDA 510(k) clearances for its spinal device systems to date, including its Bridge laminoplasty system for relieving pressure on the spinal cord. Read More
Medtronic has ceased distribution and marketing of the system and has issued a letter requesting that physicians stop implants of the device. Read More