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510(k)

By Dave Muoio | 01:28 pm | October 21, 2020
Quantib and Ezra's automated tools support diagnosis and measurement of the prostate and prostate lesions, while Aidoc's algorithm acts as an always-on catch net for unsuspected blockage of pulmonary arteries.
By Dave Muoio | 04:03 pm | August 18, 2020
While the company's new 510(k) cuts down some of the burden, consumers are still advised to consult their healthcare provider before making any changes to their treatments.
By Sara Mageit | 05:41 am | August 18, 2020
The platform aims to support patients with respiratory conditions and enables clinical decision making amongst respiratory health professionals.
By Dave Muoio | 04:19 pm | May 26, 2020
The digital respiratory health company says this deal and clearance now give it access to 90% of the U.S. asthma and COPD market.
By Laura Lovett | 02:41 pm | March 02, 2020
The software can be used on a clinician's smartphone or tablet. 
By Laura Lovett | 02:36 pm | February 03, 2020
The new system lets clinicians share or capture videos and images from the OR. 
By Laura Lovett | 04:16 pm | January 23, 2020
The latest platform provides developers and providers direct control over streaming health data. 
By Dave Muoio | 12:13 pm | January 22, 2020
A newly published notice from the FDA suggests a new capability for the Alphabet subsidiary's clinical research wearable.
By Dave Muoio | 04:18 pm | January 09, 2020
The Air Next is designed for patients with respiratory conditions such as asthma, COPD and cystic fibrosis.