Michaela Miller
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What’s Biocompatibility?
…merely treated as a checklist. Cytotoxicity? Test performed – check! Acute systemic toxicity? Test performed – check! Material mediated pyrogenicity? Test performed – check! What’s wrong with it? Some biological…
…merely treated as a checklist. Cytotoxicity? Test performed – check! Acute systemic toxicity? Test performed – check! Material mediated pyrogenicity? Test performed – check! What’s wrong with it? Some biological…
Marina Daineko
Biocompatibility Testing and Fraudulent Data in the Age of AI
…to the FDA. I know of four completely unrelated companies who unknowingly used the same testing lab, submitting similar data to the FDA – all pulled from 510(k) submissions approved…
…to the FDA. I know of four completely unrelated companies who unknowingly used the same testing lab, submitting similar data to the FDA – all pulled from 510(k) submissions approved…
Michelle Lott
ThisWeek in MedTech – August 23, 2024
…To Make Hospital ORs More Efficient Caresyntax closed a $180 million Series C extension round, bringing its Series C fundraising total to $310 million. The company sells AI-based precision surgery…
…To Make Hospital ORs More Efficient Caresyntax closed a $180 million Series C extension round, bringing its Series C fundraising total to $310 million. The company sells AI-based precision surgery…
Transitioning EU Clinical Trials: Key Steps for Compliance by 2025
…The CTD aimed for a coordinated approach to the regulation of clinical trials in all participating countries. However, this goal has been only partly achieved. Therefore, the European Commission (EC)…
…The CTD aimed for a coordinated approach to the regulation of clinical trials in all participating countries. However, this goal has been only partly achieved. Therefore, the European Commission (EC)…
Transform Medical Device Logistics With Smart Packaging Strategies
…extremely costly, especially given the price and necessity of many health care products. One example comes from two companies collaborating to bring 5G network connectivity and Internet of Things tech…
…extremely costly, especially given the price and necessity of many health care products. One example comes from two companies collaborating to bring 5G network connectivity and Internet of Things tech…
Diede van Bladel
Soaring Medical Device Scrutiny: How is the Market Adapting?
…Fortune Business Insights, June 17, 2024: https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085 [2] The independent Census-wide survey, commissioned by Schlafender Hase, was conducted in late May/early June 2024, among 202 regulatory professionals at Class 2…
…Fortune Business Insights, June 17, 2024: https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085 [2] The independent Census-wide survey, commissioned by Schlafender Hase, was conducted in late May/early June 2024, among 202 regulatory professionals at Class 2…
