This week, Eko Health received FDA clearance for a new AI-powered tool that aids in the early detection of low ejection fraction, a key indicator of heart failure. The tool, which was developed in collaboration with Mayo Clinic, is embedded into Eko’s digital stethoscopes.
The FDA cleared Levita Magnetics’ new abdominal surgery platform, which combines the company’s proprietary magnetic surgical technology with robotic assistance. The system is designed to deliver all the same patient benefits as its original magnetic surgery system — such as reduced incisions, less pain, fewer scars and speedier recovery — while also giving surgeons better control of their instruments.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
UltraSight, based in Israel, recently received a nod from the FDA to market its UltraSight AI Guidance product that can assist medical professionals without sonography experience in acquiring cardiac ultrasound images and allow for more widespread detection of heart diseases.
Virtual care company TytoCare has received FDA clearance for its wheeze detection algorithm, allowing the company to begin commercializing the product in the U.S. The new algorithm is an expansion of Tyto Insights, the company's AI-powered diagnosis support software.
Digital health company Akili Interactive received FDA de novo clearance for its digital therapeutic, a video game intended to improve attention among kids with ADHD.
Bigfoot Biomedical plans to submit an application to the FDA for clearance of its smart insulin pen caps this month. The devices pull in information from a connected glucose monitor to help users calculate the optimal insulin with each meal.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers develop a new product showing substantial equivalence.