The U.S. Food and Drug Administration (FDA) has announced that Abbott is recalling some of its Proclaim and Infinity neurostimulation systems due to an ongoing issue with patients being unable to exit MRI mode. This is a Class I recall, which means the FDA has determined the use of these devices “may cause serious injuries or death.”
While Oracle’s been in the apps business for more than 20 years and has been a player in the software-as-a-service (SaaS) market for the past 12 years, the company’s surging cloud-infrastructure business will likely become larger than the cloud-apps business by the end of 2024.
For six months, medical device makers have had to comply with new cybersecurity regulations aimed at hardening medical devices against cyber attacks, but the US Food and Drug Administration has largely refrained from using its "refuse to accept" power up to now.
With expectations to innovate higher than ever, IT leaders must ensure they have the right culture, skills, and alignment with business value when pursuing innovative IT initiatives.