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 DĂŠjĂ Vu: Lessons for AI/ML Medtech Founders from the Molecular Diagnostics Industry
Medical technology is constantly pushing boundaries, and with it comes the ever-present challenge of securing reimbursement for innovative solutions. The path to widespread adoption for any new technology is paved…
Medical technology is constantly pushing boundaries, and with it comes the ever-present challenge of securing reimbursement for innovative solutions. The path to widespread adoption for any new technology is paved…
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
…legal structure for medical devices, introducing new responsibilities and requirements for EMA and national competent authorities in the assessment of certain categories of medical devices used in combination with medicines….
…legal structure for medical devices, introducing new responsibilities and requirements for EMA and national competent authorities in the assessment of certain categories of medical devices used in combination with medicines….
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…
Hogan Lovells Engage
