This month, Moon Surgical received FDA clearance for the commercial version of its Maestro surgical robot system. The system is designed to support surgeons and other operating room staff, specifically for the 18.8 million annual soft tissue surgical procedures not currently supported by available telerobotic systems.

The post Why Is Moon Surgical’s New Commercial Robot System Important? appeared first on MedCity News.

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 post Eko Health Gains FDA Clearance For Cardiology Algorithm That Can Detect Heart Failure in 15 Seconds appeared first on MedCity News.

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.

The post FDA Clears New Surgical Platform Combining Robotics & Magnetics appeared first on MedCity News.

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.

The post FDA Clearance Spotlight: UltraSight appeared first on MedCity News.

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.

The post FDA Clears TytoCare’s New Algorithm for Wheeze Detection appeared first on MedCity News.

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.

The post In a first, FDA clears video game for kids with ADHD appeared first on MedCity News.

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.

The post With $55M in new funding, Bigfoot Biomedical takes strides toward FDA submission appeared first on MedCity News.

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.

The post FDA considering imposing 10-year limit when manufacturers choose older predicates appeared first on MedCity News.