Maria Avramidou
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Anne-Gabrielle Haie
Reliable Active Surveillance: RWE for MedTech
…challenge. Introduction to aiSurveillance aiSurveillance is a new approach combining data science and clinical science, developed specifically for the MedTech industry. aiSurveillance software integrates real-world data (RWD) sources, such as…
…challenge. Introduction to aiSurveillance aiSurveillance is a new approach combining data science and clinical science, developed specifically for the MedTech industry. aiSurveillance software integrates real-world data (RWD) sources, such as…
Reimbursement DĆ©jĆ Vu: Lessons for AI/ML Medtech Founders from the Molecular Diagnostics Industry
…pioneering molecular diagnostic test for breast cancer, and Viz.ai, an AI-powered platform originally approved for stroke detection, serve as illustrative case studies. By examining the specific hurdles encountered by these…
…pioneering molecular diagnostic test for breast cancer, and Viz.ai, an AI-powered platform originally approved for stroke detection, serve as illustrative case studies. By examining the specific hurdles encountered by these…
Nicole Coustier
FDA under fire: Pared-down LDT Final Rule leaves unanswered questions
…test and make modifications. The Final Rule makes clear that the agency plans to exercise enforcement discretion over such modified third party-developed and legally marketed tests if: the original test…
…test and make modifications. The Final Rule makes clear that the agency plans to exercise enforcement discretion over such modified third party-developed and legally marketed tests if: the original test…
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…
