510(k) clearance
The algorithms are used to detect valvular heart disease.
Novii+ allows for continuous monitoring of high-risk pregnancies after 34 weeks, and alerts care teams of heart rate and contraction patterns during labor.
The AI-enabled hearing aids automatically adjust to an individual's hearing needs without configuration.
The AI-powered app allows for remote monitoring of common Parkinson's disease symptoms such as bradykinesia, tremor and dyskinesia via an Apple Watch.
It follows the clearance for connecting Hailie with AstraZeneca's Symbicort inhaler.
This comes just a month after news broke Nanox was set to acquire Zebra Medical Vision.
The company landed a 510(k) for its single-source digital X-ray Nanox.ARC, and said more clearances are in the pipeline.
The ECG app can detect over 98% of atrial fibrillation cases and was 100% accurate in identifying participants with normal sinus rhythm, according to study results.
Zebra Medical Vision's tool interprets medical imaging and flags potential cases for specialist review.
The new guidance aims to modernize the process and generate more market competition.