Public Policy
The test measures for PdG in urine to confirm that successful ovulation took place.
The company also announced a commercialization deal with Novo Nordisk.
EndoArt successfully passed clinical trials, gaining China’s Innovative Device Status and FDA approval.
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.
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.
The new safety feature will require users to set a 4-digit passcode to unlock the treadmill band.
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.
Viome has adapted its technology to search for the presence of oral squamous cell carcinoma and oropharyngeal cancer in users’ saliva samples.
A white paper from Research2Guidance finds that gaining DiGA approval alone does not ensure the adoption and success of healthcare apps.