Increasing savvy around cybersecurity issues is driving regulators and trade groups to update their approach to the area, speakers from the US FDA and the American Medical Association said at this week’s FDA/CMS Summit.
Two major documents on medical device cybersecurity will likely be issued in the next several months, a US Food and Drug Administration official said at this week’s FDA/CMS Summit in Arlington, VA.
The first document, from the International Medical Device Regulators Forum (IMDRF), offers international consensus guidelines on device cybersecurity. The comment period closed on 2 December, and the IMDRF is...
Congress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.
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 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.
In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her conference coverage from CES, HIMSS, AAOS and LSI including Exec Chats with Gary Guthart, CEO of Intuitive Surgical, and Arcadia’s chief strategy officer Aneesh Chopra. Brian Bossetta highlights a recently FDA-cleared alert system that sends vital signs to clinicians. Elizabeth Orr discusses FDA warning letters sent to Exer Labs for exceeding marketing claims under what is allowed under the device’s 510(k) clearance. Shubham Singh discusses how Roche's unveiling of its next-generation sequencing (NGS) prototype challenges Illumina. The SBX technology is set to compete directly with Illumina’s NovaSeq and NextSeq platforms.
Medtech Insight spoke with Hubert Martens, CEO of Netherlands-based neuromodulation company Salvia Bioelectronics, about the company’s innovative implant for treating chronic migraines, ongoing clinical trials and plans for US clinical trials and commercialization.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.
