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Regulation

By Sophie Porter | 09:29 am | June 08, 2021
EndoArt successfully passed clinical trials, gaining China’s Innovative Device Status and FDA approval.
By Mallory Hackett | 01:42 pm | June 03, 2021
Canvas Dx is indicated as an aid in the diagnosis of ASD in patients between the ages 18 months and 5 years old who are at risk of developmental delay.   
By Tammy Lovell | 12:50 pm | May 26, 2021
The new legislation is intended to improve the safety of medical devices. 
Patient and providers are looking to remote monitoring for the future, but incentive structures fall short. 
By Laura Lovett | 03:17 pm | May 20, 2021
The new safety feature will require users to set a 4-digit passcode to unlock the treadmill band. 
By Mallory Hackett | 12:58 pm | May 10, 2021
The system was cleared for use among individuals 12 years old and up with Type 1 or Type 2 diabetes on multiple-dose injection therapy.  
By Mallory Hackett | 12:24 pm | May 07, 2021
Viome has adapted its technology to search for the presence of oral squamous cell carcinoma and oropharyngeal cancer in users’ saliva samples.   
By Mallory Hackett | 12:42 pm | April 22, 2021
AliveCor asserts that Apple knowingly copied its patented technology in an effort to squash it as a market competitor.   
By Laura Lovett | 12:40 pm | April 19, 2021
Peloton fights back against the CPSC warning, calling it "inaccurate and misleading." 
By Laura Lovett | 03:49 pm | April 15, 2021
The tech is able to give surgeons real-time intraoperative visual data.