Adherium, the makers of inhaler sensors, has received 510(k) US-FDA clearance for the sales of its Hailie sensor, previously known as Smartinhaler. The individual versions of this device were previously cleared for use with the asthma inhalers like Ventolin HFA, ProAir HFA, and Flovent HFA.
Endomag received premarket approval from the FDA for Magtrace, the novel non-radioactive dual-tracer for lymphatic plotting in breast cancer patients which facilitates the implementation of magnetic detection during sentinel lymph node biopsy procedures to spot sentinel lymph nodes for surgical excision.
A new therapeutic pill named elagolix will now become available for endometriosis-related pain, after getting approved by the US Food and Drug Administration. This newly-approved drug can be taken for longer durations but also has several side-effects like headaches, hot flushes and nausea.
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.
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