Proximie’s software development kit (SDK) will be used by surgeons, healthcare organisations and medical device companies to advance the field of surgery.
The trial will build data to help Empatica’s wearable tech identify a form of seizure that can occur when medications stop working.
The clearance allows paediatric surgeons and medical facilities to treat younger patients using the VersaWrap Class II medical device.
The new proposed rule published in October 2023 states the FDA’s intention to regulate LDTs, including those that are manufactured by a laboratory.
The SiteRite 9 vascular access ultrasound system comprises integrated visualisation tools.
Established in 2021, Vyrsa offers sacroiliac (SI) joint fusion devices approved by the US Food and Drug Administration (FDA).
The device is designed to precisely introduce diagnostic and therapeutic devices into the vasculature in a streamlined manner.
Culmination Bio has a library of electronic health records and biospecimen data that help in drug and diagnostic device development.