Latest from Brian Bossetta
The US FDA has granted clearance to eMurmur, broadening the use of its AI-powered software platform. The innovative system identifies primary heart sounds to detect abnormal murmurs as they occur.
The US FDA has published a draft guidance on clinical performance testing and evaluation for premarket submissions from manufacturers of cuffless blood pressure measuring monitors, which the agency generally regulates as class II devices.
As the deadline for the US FDA’s new quality system incorporating international standards fast approaches, the agency held a town hall to offer industry some last-minute tips to get ready for the regulatory framework.
Chatbots can churn out valuable information to patients and give much needed assistance to healthcare personnel. But their mistakes can lead to significant patient harm, which is why ECRI ranks their misuse as the top health technology hazard for 2026.
The US FDA has issued an early alert concerning some Axios stent and delivery systems used in endoscopic drainage procedures after receiving reports of serious injuries and deaths linked to the device.
FDA updates pair of guidance documents relaxing its posture on how it regulates general wellness devices and clinical support software. Industry mostly welcomes changes, agreeing with agency’s view that lighter regulation will help spur innovation.
