Maria Avramidou
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Anne-Gabrielle Haie
Reliable Active Surveillance: RWE for MedTech
…richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently….
…richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently….
Reimbursement DĆ©jĆ Vu: Lessons for AI/ML Medtech Founders from the Molecular Diagnostics Industry
…diagnostics offers a roadmap for AI/ML companies to navigate the complexities of reimbursement, such as: Advocate for Regulatory Clarity: Engage with regulatory bodies and policymakers to advocate for clear-cut regulatory…
…diagnostics offers a roadmap for AI/ML companies to navigate the complexities of reimbursement, such as: Advocate for Regulatory Clarity: Engage with regulatory bodies and policymakers to advocate for clear-cut regulatory…
Nicole Coustier
FDA under fire: Pared-down LDT Final Rule leaves unanswered questions
…significantly increased complexity of LDTs compared to when the policy was initially put in place. Enforcement timeline and phaseout policy Similar to the proposed rule, the Final Rule will gradually…
…significantly increased complexity of LDTs compared to when the policy was initially put in place. Enforcement timeline and phaseout policy Similar to the proposed rule, the Final Rule will gradually…
Combination Devices: new guidance for industry and notified bodies
…considerations on the implementation of the medical devices and in vitro diagnostic regulations for combinations of medicinal products and medical devices. Products that combine a medicinal product (or substance) and…
…considerations on the implementation of the medical devices and in vitro diagnostic regulations for combinations of medicinal products and medical devices. Products that combine a medicinal product (or substance) and…
CUE Health lays off entire staff
According to SFGate, the San Diego-based medical tech company announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations. Today’s announcement…
According to SFGate, the San Diego-based medical tech company announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations. Today’s announcement…
The Role of EPSS in Prioritizing IoMT Security Threats
…FIRST, https://www.first.org/epss/model [iii] “Exploit Prediction Scoring System,” FIRST, https://www.first.org/epss/ [iv] “Common Vulnerability Scoring System SIG,” FIRST, https://www.first.org/cvss/ [v] “Exploit Prediction Scoring System,” FIRST, https://www.first.org/epss/ [vi] “NIST Cybersecurity Framework, NIST, https://www.nist.gov/cyberframework…
…FIRST, https://www.first.org/epss/model [iii] “Exploit Prediction Scoring System,” FIRST, https://www.first.org/epss/ [iv] “Common Vulnerability Scoring System SIG,” FIRST, https://www.first.org/cvss/ [v] “Exploit Prediction Scoring System,” FIRST, https://www.first.org/epss/ [vi] “NIST Cybersecurity Framework, NIST, https://www.nist.gov/cyberframework…
HeartFlow AI Plaque Analysis Shows 95% Accuracy vs. Invasive Imaging
The multicenter international study, which enrolled 258 patients across 15 sites in the U.S. and Japan, compared HeartFlow’s automated deep-learning-based method for segmenting coronary atherosclerosis in coronary computed tomography angiography…
The multicenter international study, which enrolled 258 patients across 15 sites in the U.S. and Japan, compared HeartFlow’s automated deep-learning-based method for segmenting coronary atherosclerosis in coronary computed tomography angiography…
