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FDA 510(k)

By Emily Olsen | 01:06 pm | April 13, 2022
The company said it's currently focused on managing end-stage kidney disease, but it's investigating using the system for other clinical areas.
By Emily Olsen | 04:01 pm | April 06, 2022
This marks Aidoc's second FDA 510(k) so far this year.
By Emily Olsen | 02:33 pm | January 20, 2022
Also: Truepill launches a COVID-19 test coverage platform for insurers, and 23andMe extends its partnership with GSK.
By Emily Olsen | 02:18 pm | December 01, 2021
Regulora delivers behavioral therapy based on gut-directed hypnotherapy through a smartphone app.
By Mallory Hackett | 03:09 pm | September 28, 2021
Providers can use SimpleSense to remotely triage cardio, pulmonary and upper vascular patients.  
By Mallory Hackett | 12:35 pm | September 28, 2020
Alongside the launch of the Rad-G device is the Rad-G sensor, which is intended for both adult and pediatric patients.
By Dave Muoio | 04:15 pm | August 24, 2020
The consumer genomics company's existing offering, called AncestryHealth, sold clinician-ordered tests that were not cleared or approved by the FDA.            
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 Dave Muoio | 12:08 pm | June 26, 2020
The device monitors vitals from up to four feet away, and is designed for use in healthcare settings or at home.
By Dave Muoio | 03:51 pm | June 03, 2020
Healthcare providers use a web interface to prescribe an initial dose "and BlueStar does the rest," according to Welldoc's chief medical officer.