Healthy.io, of Israel, gains FDA 510(k) approval for Dip.io, it's domestic urinalysis kit that transforms a smartphone into a clinical-standard diagnostic machine. It is the first and only smartphone-based urine analysis to be cleared as a Class 2 device.
Siemens Health received US-FDA (US-Food and Drug Administration) clearance for two highly sensitive troponin assays, which detect protein levels released into the bloodstream during a heart attack allowing them to be made available in the U.S.
On 26 July 2018, Omeros Corporation announced that the European Medicines Agency's (EMA's) Committee for Orphan Medicinal Products (COMP) have positively recommended the lead human monoclonal antibody named OMS721 for stem cell transplantation therapy.
Nucala (mepolizumab) was first approved as the first anti-IL5 treatment for adults and adolescents with severe asthma accompanied by eosinophilic phenotype in the United States during November 2015. Later it was approved to treat eosinophilic granulomatosis with polyangiitis (EGPA).
Telemedicine helps Nashville-based Vanderbilt University Medical Center take its kidney transplant program to the people of Tennessee and give them the prospect to be screened for a transplant and bring constant care within their reach.
The Newton Massachusetts-based company, Karyopharm Therapeutics, who developed a new class of drugs to treat multiple myeloma, is in the process of submitting a new drug application to the FDA for their selinexor drug.
The US Army is testing a telemedicine-based platform designed to send critical data from the field to the hospital and enabling providers to prepare for incoming patients. The connected care service is used by health systems and EMS providers for better care coordination during emergencies.
ElectroCore, famous for bioelectronic medicines, is associating with UpScriptHealth to deliver its gammaCore treatment via direct-to-patient telemedicine program. This non-invasive stimulation therapy of vagus nerve is used to treat migraines and episodic cluster headaches among the adults.
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