Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. Medtronic has a commercialization deal with the company for the device, which uses a pacing algorithm to actively lower blood pressure in people with pacemakers.
Israeli medical device developer Magenta Medical recently closed a $55 million financing round. The new funding will be used primarily to help Magenta attain FDA approval for its flagship product — a percutaneous left ventricular assist device called Elevate.
There are a number of criteria for selecting the best autism therapy centers. Parents choosing a facility or professionals seeking to improve their offerings should consider certain standards to ensure the right fit.
Our analysis demonstrates that CMS’s coverage processes for breakthrough devices demonstrate product class and disease state disparities. These disparities contradict mental health parity statute, CMS Administrator Brooks-LaSure’s focus on equity, and President Biden’s charge to improve brain health.