Industry News

• FDA permits marketing of first medical device for treatment of ADHD  The FDA permitted marketing of the first medical device to treat ADHD. The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication.
  April 19, 2019  
• Study shows promise in repairing damaged myelin  A scientific breakthrough provides new hope for millions of people living with MS. Researchers at OHSU have developed a compound that stimulates repair of the protective sheath that covers nerve cells in the brain and spinal cord. The discovery was published in the journal JCI Insight.
  April 19, 2019  
• FDA approves first generic naloxone nasal spray to treat opioid overdose  The FDA granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose.
  April 19, 2019  
• In rare cases, immune system fails despite HIV suppression  Antiretroviral therapy is usually very effective at suppressing HIV in the body, allowing a person’s immune system to recover by preventing the virus from destroying CD4+ T cells. Scientists have now identified a rare, paradoxical response to ART known as extreme immune decline, or EXID.
  April 18, 2019  
• Decline in measles vaccination is causing a preventable global resurgence of the disease  In 2000, measles was declared to be eliminated in the U.S., when no sustained transmission of the virus was seen in this country for more than 12 months. Today,the U.S. and many other countries are experiencing concerning outbreaks of measles because of declines in vaccine coverage.
  April 18, 2019  
• NIH funds study in four states to reduce opioid related deaths by 40 percent  The NIH selected four research sites for the HEALing Communities Study in four states hard hit by the opioid crisis. The study aims to reduce overdose deaths by 40 percent over three years in selected communities by testing a set of proven prevention and treatment interventions.
  April 18, 2019  
• National experts chart roadmap for AI in medical imaging  A foundational research roadmap for artificial intelligence in medical imaging was published in the journal Radiology. The report was based on outcomes from a workshop to explore the future of AI in medical imaging.
  April 18, 2019  
• Hologic receives European CE Mark for ThinPrep® Genesis processor  Hologic announced the ThinPrep® Genesis processor for cytology slide and molecular test preparation has received a CE IVD mark in Europe. The system features increased automation capabilities, together with ergonomic and chain of custody benefits, compared to older instruments.
  April 18, 2019  
• Edwards Lifesciences completes acquisition of CASMED  Edwards Lifesciences announced completion of its acquisition of CAS Medical Systems, a medical technology company dedicated to non-invasive brain and tissue oxygenation monitoring. Edwards paid $2.45 in cash for each common share of CASMED, which equates to an equity value of $100 million.
  April 18, 2019  
• Akorn receives FDA approval for fluticasone propionate nasal spray USP, 50 mcg per spray  Akorn announced that it received a new ANDA approval from the FDA for Fluticasone Propionate Nasal Spray USP, 50 mcg per spray. Fluticasone propionate nasal spray USP, 50 mcg per spray is indicated for temporary relief of hay fever and other upper respiratory allergies.
  April 18, 2019  

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