The Medical “Firsts” of 2014

Slideshow

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  First HPV Test for Primary Cervical Cancer

  The FDA approved Roche's cobas HPV Test, the first human papillomavirus (HPV) DNA test for women ages 25 and older that can be used alone to help assess the need for additional diagnostic testing for cervical cancer. This test also can provide information about the patient's risk for developing cervical cancer in the future.

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  First-in-Class Drug Approved for Insomnia

  The FDA approved Belsomra (suvorexant; Merck) tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra has been scheduled as a CIV controlled substance due to its abuse and dependence potential.

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  First Neurogenic Orthostatic Hypotension Drug

  Lundbeck announced the availability of Northera (droxidopa) capsules for the treatment of orthostatic dizziness and lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (eg, Parkinson's disease, multiple system atrophy, pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.

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  First TENS Device for Migraine Prevention

  Cefaly Technology received FDA marketing approval for Cefaly, the first transcutaneous electrical nerve stimulation (TENS) device for the preventative treatment of migraine headaches. It is also the first TENS device specifically authorized for use prior to the onset of migraine pain.

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  First Global Report on Antibiotic Resistance

  The World Health Organization (WHO) released its first report on global antimicrobial resistance, including antibiotic resistance. The organization now considers antibiotic resistance a major threat to public health worldwide. The report discusses resistance to various infectious agents but emphasizes 7 bacteria responsible for common and serious diseases like bloodstream infections (sepsis), diarrhea, pneumonia, urinary tract infections, and gonorrhea.

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  First Naloxone Product for Caregiver Administration

  Kaléo, Inc. announced that Evzio (naloxone HCl injection) auto-injector is now commercially available for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or CNS depression. Evzio is the first naloxone product allowing administration by family members or caregivers.

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  First Genetic Identifier for Autism Found

  In a study led by clinical director Dr. Raphael Bernier of Seattle Children's Autism Center and Associate Professor at the University of Washington, a mutation of the CHD8 gene that not only significantly increases a child's risk for developing a specific subtype of autism but also causes several physical traits and symptoms unique to children of the same subtype has been discovered.

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  First-of-Kind Prosthetic Arm

  DEKA Integrated Solutions received FDA approval for the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrode in individuals with upper extremity amputations occurring at the shoulder joint, mid-upper arm, or mid-lower arm.

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  First Device for RLS-Disrupted Sleep

  The FDA granted commercial clearance to Sensory Medical for Relaxis, the first nonpharmacological medical device to improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS).

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  First Hands-Only CPR Device

  The FDA approved CPR RsQ Assist, the first FDA-approved hands-only chest compression device designed to reduce fatigue and intimidation that are associated with performing traditional CPR.

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  Hydrocodone Combo Products Now Schedule II

  The DEA issued its final rule rescheduling hydrocodone combination products as a Controlled Substance Schedule II, effective October 6, 2014.

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  First Wearable, Motorized Exoskeleton for Paraplegics

  ReWalk Robotics announced that the ReWalk Personal System received FDA clearance for use at home and in the community. It is the first motorized device intended to act as an exoskeleton in individuals with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra) when accompanied by a specially trained caregiver, and for those with injuries at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra), where the device is limited to use in rehabilitation institutions.

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  First Ebola Case Diagnosed in U.S.

  The CDC confirmed the first case of Ebola to be diagnosed in the United States in a male who traveled to Dallas, TX from Liberia.

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  First Human Milk-Based Premature Infant Formula

  Prolacta Bioscience announced the launch of Prolact RTF, the first ready-to-feed (RTF) human milk-derived premature infant formula.

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  First Single-Dose IV Antibiotic for Severe Skin Infections

  The FDA approved Orbactiv (oritavancin), the first and only single-dose antibiotic administered intravenously for the treatment of acute bacterial skin and skin structure infections caused by certain susceptible designated Gram-positive bacteria.

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  First Meningococcal B Vaccine Approved by FDA

  The FDA approved Trumenba (Pfizer), the first vaccine approved in the U.S. to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B. Trumenba vaccine is indicated for patients aged 10–25 years.

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  First Wireless Microchip Device for Back, Leg Pain

  The FDA granted clearance to Stimwave Technologies to market the Stimwave Freedom Spinal Cord Stimulation (SCS) System, the first wireless, microtechnology neuromodulation device for chronic back and leg pain relief.

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  First Smartphone-Connected Thermometer

  Kinsa Health announced the availability of the Kinsa Smart Thermometer, the first FDA-cleared smartphone-connected thermometer and health tracking app.

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  First Stool DNA Colorectal Cancer Screening Test

  Exact Sciences announced the FDA approval of Cologuard, the first non-invasive DNA screening test for colorectal cancer. It is the first non-invasive diagnostic test for colorectal cancer that analyzes both blood biomarkers and stool DNA.

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  First Study to Show Statin + Non-Statin Combo Having Clinical Benefit

  Merck announced that patients in the IMPROVE-IT study taking ezetimibe/simvastatin (Vytorin) experienced significantly fewer cardiovascular events compared to those taking simvastatin alone. This is the first study to show that reducing low-density lipoprotein cholesterol (LDL-C) with a combination of a statin and non-statin to levels lower than those achieved with the statin alone is associated with significant clinical benefit.