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Cybersecurity Guidance Update Lays Out ‘Cyber Device’ Rules

 
• By Elizabeth Orr

Draft guidance from the US Food and Drug Administration details what the agency wants to see to demonstrate cybersecurity in connected devices during premarket submissions. 

Cybersecurity
• Source: Shutterstock

A draft update to the US Food and Drug Administration’s guidance document on premarket regulation of medical device cybersecurity clarifies the agency’s expectations around establishing cyber threat protection in submissions for so-called “cyber devices.”

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Birmingham City University Develops New Defense Mechanism Against Cyberattacks On AI Systems

 
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AI systems used in healthcare are vulnerable to adversarial cyberattacks, which are a growing concern, said Atif Azad, a professor of AI at Birmingham City University. Azad’s research group has developed a method that trains AI to become more resilient to cyber threats through the use of random image adjustments.

Enovis Appoints Damien McDonald CEO, Reaffirms Q1 Guidance Amid Strategic Growth Push

 
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Enovis has named veteran medtech leader Damien McDonald as its new CEO effective 12 May as the orthopedic company reaffirms first-quarter 2025 revenue guidance of between $555m and $563m. Medtech Insight spoke with Tim Czartoski, Enovis’ president of US surgical and global product and enabling technologies, about the firm’s growth strategy and innovation plans.

LSI 2025: Intuitive Surgical CEO Gary Guthart On da Vinci 5’s Force Feedback, Digital Coaching, ION Expansion, And Robotic Surgery’s Future

 
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More from Digital Technologies

Anglonordic 25: Women’s Health Needs Therapeutic Success To Encourage Wider Investment

 
• By Natasha Barrow

Health tech is at the forefront of the women's health sector, securing 38% of venture capital in 2024. However, panelists at the Anglonordic Life Science Conference held 3 April asserted that a successful therapeutic breakthrough is key to gaining investor confidence and accelerating venture capital.

Enovis Appoints Damien McDonald CEO, Reaffirms Q1 Guidance Amid Strategic Growth Push

 
• By Marion Webb

Enovis has named veteran medtech leader Damien McDonald as its new CEO effective 12 May as the orthopedic company reaffirms first-quarter 2025 revenue guidance of between $555m and $563m. Medtech Insight spoke with Tim Czartoski, Enovis’ president of US surgical and global product and enabling technologies, about the firm’s growth strategy and innovation plans.

AI-Powered Robotics: Monogram Bets On ‘Active’ Assistance With FDA-Cleared Robotic Knee System To Outperform Stryker’s Haptics

 
• By Shubham Singh

Beyond the US market, Monogram is actively pursuing regulatory approvals abroad, with India as a key target. The company has partnered with Shalby Hospitals, one of India’s largest orthopedic hospital networks, to conduct clinical trials and accelerate regulatory clearance in the region.