New Approvals – Page 3 – media

FDA Approves Healthy.io Smartphone Camera-based Home Urine Analysis

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.
- Source: MobiHealthNews
- 590
- July 27, 2018
FDA mHealth New Approvals
Siemens gets FDA Clearance for Troponin Assay

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.
- Source: FierceBiotech
- 1,026
- July 27, 2018
blood test heart attacks New Approvals troponin assay
Good Feedback for OMS721 Stem Cell Transplant Therapy

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.
- Source: News Medical
- 850
- July 27, 2018
hematopoietic stem cells New Approvals
Enquiry for Nucala in COPD

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).
- Source: BioPharmaDive
- 772
- July 26, 2018
COPD GSK New Approvals
Europe Approves InPen; Makes Insulin Injections Easier

San Diego based Companion Medical got its InPen insulin management system certified with the European CE Mark of approval.
- Source: MedGaget
- 328
- July 26, 2018
diabetes insulin mHealth New Approvals
NHS to Utilize $540 Million New Funding to Boost Hospital IT

Matt Hancock, new Health and Social Care Secretary, announced that information technology would be among his prime subject of focus for the betterment of National Health Service.
- Source: HealthcareIT News
- 763
- July 25, 2018
digital health EHR New Approvals
Telemedicine Helps Vanderbilt Expand its Transplant Center’s Reach

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.
- Source: mHealth Intelligence
- 717
- July 25, 2018
digital health New Approvals Telemedicine
Karyopharm Seeks FDA Approval for Selinexor Drug for Multiple Myeloma

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.
- Source: MedCityNews
- 411
- July 24, 2018
cancer CAR-T therapies FDA New Approvals
US Army Awaiting to Test MEDHUB – A Telemedicine Platform

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.
- Source: mHealth Intelligence
- 748
- July 23, 2018
New Approvals Telemedicine
New 3D Color X-Rays to Diagnose Cancer, Heart Disease and More

The first-ever 3D, color X-rays were tested on a human by New Zealand Scientists, using technology that promises to enhance medical diagnostics in oncology, cardiology, neurology and orthopedics.
- Source: Medical Design and Outsourcing
- 1,215
- July 20, 2018
3D medical device New Approvals x-ray

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