FDA Clearance Archives - MedCity News https://medcitynews.com/tag/fda-clearance/ Healthcare technology news, life science current events Thu, 24 Aug 2023 00:07:34 +0000 en-US hourly 1 https://wordpress.org/?v=6.3.1 https://medcitynews.com/uploads/2021/03/cropped-mblue-32x32.png FDA Clearance Archives - MedCity News https://medcitynews.com/tag/fda-clearance/ 32 32 40682243 FDA Clears New Surgical Platform Combining Robotics & Magnetics https://medcitynews.com/2023/08/fda-robotic-surgery-magnetics/ https://medcitynews.com/2023/08/fda-robotic-surgery-magnetics/#respond Wed, 23 Aug 2023 22:05:28 +0000 https://medcitynews.com/?p=646260

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.

]]> https://medcitynews.com/2023/08/fda-robotic-surgery-magnetics/feed/ 0 646260 FDA Clearance Spotlight: UltraSight https://medcitynews.com/2023/08/fda-clearance-spotlight-ultrasight/ https://medcitynews.com/2023/08/fda-clearance-spotlight-ultrasight/#respond Thu, 03 Aug 2023 19:03:08 +0000 https://medcitynews.com/?p=643965

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.

]]> https://medcitynews.com/2023/08/fda-clearance-spotlight-ultrasight/feed/ 0 643965 FDA Clears TytoCare’s New Algorithm for Wheeze Detection https://medcitynews.com/2023/03/fda-clears-tytocares-new-algorithm-for-wheeze-detection/ https://medcitynews.com/2023/03/fda-clears-tytocares-new-algorithm-for-wheeze-detection/#respond Wed, 15 Mar 2023 20:39:04 +0000 https://medcitynews.com/?p=627543

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.

]]> https://medcitynews.com/2023/03/fda-clears-tytocares-new-algorithm-for-wheeze-detection/feed/ 0 627543 In a first, FDA clears video game for kids with ADHD https://medcitynews.com/2020/06/in-a-first-fda-clears-video-game-for-kids-with-adhd/ https://medcitynews.com/2020/06/in-a-first-fda-clears-video-game-for-kids-with-adhd/#respond Tue, 16 Jun 2020 01:23:02 +0000 https://medcitynews.com/?p=490883

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.

]]> https://medcitynews.com/2020/06/in-a-first-fda-clears-video-game-for-kids-with-adhd/feed/ 0 490883 With $55M in new funding, Bigfoot Biomedical takes strides toward FDA submission https://medcitynews.com/2020/06/with-55m-in-new-funding-bigfoot-biomedical-takes-strides-toward-fda-clearance/ https://medcitynews.com/2020/06/with-55m-in-new-funding-bigfoot-biomedical-takes-strides-toward-fda-clearance/#respond Thu, 04 Jun 2020 00:00:50 +0000 https://medcitynews.com/?p=490121

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.

]]> https://medcitynews.com/2020/06/with-55m-in-new-funding-bigfoot-biomedical-takes-strides-toward-fda-clearance/feed/ 0 490121 FDA considering imposing 10-year limit when manufacturers choose older predicates https://medcitynews.com/2018/11/fda-considering-imposing-10-year-limit-when-manufacturers-choose-older-predicates/ https://medcitynews.com/2018/11/fda-considering-imposing-10-year-limit-when-manufacturers-choose-older-predicates/#respond Mon, 26 Nov 2018 22:38:41 +0000 https://medcitynews.com/?p=447910 FDA

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.

]]> https://medcitynews.com/2018/11/fda-considering-imposing-10-year-limit-when-manufacturers-choose-older-predicates/feed/ 0 447910