Penetration testing, which involves ethical hackers identifying vulnerabilities before malicious actors can exploit them, is crucial for securing medical devices against cyber threats. The process is essential for compliance with regulations, preventing financial losses, and ensuring patient safety, cybersecurity experts say.
PharmStars CEO Naomi Fried spoke with Medtech Insight about the Boston-based virtual accelerator, which brings together digital health-focused start-ups with pharmaceutical companies to accelerate deals. Executives from Elemeno Health, Head Diagnostics and JOGO Health who participated in the PharmaU program and final pitching event to PharmStars’ pharma members talked about their experiences, the value proposition and challenges in securing a pharma deal.
Penetration testing, which involves ethical hackers identifying vulnerabilities before malicious actors can exploit them, is crucial for securing medical devices against cyber threats. The process is essential for compliance with regulations, preventing financial losses, and ensuring patient safety, cybersecurity experts say.
Applications for the AI Airlock regulatory sandbox pilot phase closed in October. The selected technologies address hospital administrative load, earlier treatment intervention and real-time AI monitoring.
PharmStars CEO Naomi Fried spoke with Medtech Insight about the Boston-based virtual accelerator, which brings together digital health-focused start-ups with pharmaceutical companies to accelerate deals. Executives from Elemeno Health, Head Diagnostics and JOGO Health who participated in the PharmaU program and final pitching event to PharmStars’ pharma members talked about their experiences, the value proposition and challenges in securing a pharma deal.
Patient safety group ECRI put AI-enabled applications at the top of its annual list of health hazards for 2025. The group says that despite its enormous potential, artificial intelligence presents the most significant risk among health technologies going into the new year.
Keep an eye on next year’s over-the-counter drug user fee negotiations for insights into the incoming Republican administration's approach to device regulation, attorneys said in a recent webinar. Other areas to watch include AI and diagnostics regulation, with potential bipartisan agreement on AI oversight
A Medtronic-funded study will use Tempus’ Next Cardiology platform to identify aortic and mitral heart valve disease patients who are being undertreated.
The FDA’s final guidance on PCCPs for AI-driven devices highlights rapid advancements in health care AI, providing a roadmap for future progress. It emphasizes iterative improvements, version control, and maintaining device safety and effectiveness.
The head of the Korea Regulatory Science Center discusses why regulatory science is crucial, the country's efforts to improve in the area and the center's strategic bridging role.
