Record Number Of Novel Medical Devices Approved By The FDA In 2018
According to Scott Gottlieb, Commissioner of the U.S. Food & Drug Administration, a record 106 novel medical devices were approved in 2018, surpassing the 40-year approval record set in 2017, which was 99. Innovative new products that have come to market in 2018 as a result of an efficient, risk-based approach to total product life-cycle regulation include: expanded approval of an automated insulin dosing system to include patients with diabetes who are as young as age seven; the world’s smallest heart valve for newborns; the first blood test in the world to evaluate mild traumatic brain injury (“concussion”); the first mobile medical app to help treat substance abuse disorders; technologies using artificial intelligence to detect diabetic retinopathy in adults with diabetes and for aiding providers in the detection of wrist fractures. Additional approvals included the first artificial iris in the U.S. and permitted marketing of a new prescription medical device that measures eye movement as an aid in the diagnosis of concussion.
Nearly One-Quarter Of Antibiotic Prescriptions Filled Are Unnecessary
Of the 15.5 million antibiotic prescriptions filled in 2016 by a population of 19.2 million privately insured children and adults under age 65, nearly one-quarter were unnecessary, according to a study funded by the Agency for Healthcare Research and Quality (AHRQ). Published on January 17, 2019 in the journal BMJ, the results indicate that an additional 36% of antibiotic prescriptions in 2016 were only "potentially appropriate." The analysis provides the most comprehensive estimates to date of inappropriate prescribing of antibiotics among individuals with private, employer-sponsored insurance. Appropriate antibiotic prescribing means that the medication is recommended for the patient's condition. Researchers conducted a combined analysis of a U.S. medical claims database and the 2016 version of an international system for categorizing diseases (ICD-10-CM). The analysis provides the most comprehensive estimates to date of inappropriate prescribing of antibiotics among individuals with private, employer-sponsored insurance.
HEALTH TECHNOLOGY CORNER
Enhanced Toy Dog Robot Includes An Ability To Learn From Its Owners
According to the January 2019 issue of the journal Science Robotics, the return of Aibo, Sony’s toy dog first introduced nearly 20 years ago, is welcomed by many, and not just because of its new appearance, enhanced voice understanding, and its improved ability to learn from its owners. In the new addition, the robot has been developed with Sony’s increasing awareness of the role that robots can play in childhood learning or as a companion for the aged, particularly those with neurodegenerative diseases. Understanding the perception, interaction, and expectations of humans around the robot and developing robot behavior and personality that are context aware (not dependent on pre-scripted programs and with personalization and adaptation) are interesting topics in social robotics. The device was highlighted in the journal as one of 10 Robotic Technologies Of The Year.
Electrical Stimulation Of The Brain During Surgery Produces Immediate Laughter And Calm
Neuroscientists at Emory University School of Medicine have discovered a focal pathway in the brain of a patient that when electrically stimulated causes immediate laughter, followed by a sense of calm and happiness, even during awake brain surgery. The behavioral effects of direct electrical stimulation of the cingulum bundle, a white matter tract in the brain, were confirmed in two other epilepsy patients undergoing diagnostic monitoring. The findings were published on February 11, 2019 in the Journal of Clinical Investigation. The technique is viewed as a potentially transformative way to calm some patients during awake brain surgery, even for individuals who are not especially anxious. For optimal protection of critical brain functions during surgery, patients may need to be awake and not sedated, so that doctors can talk with them, assess their language skills, and detect impairments that may arise from resection. Outside of use during awake surgery, understanding how cingulum bundle stimulation works also could inform efforts to treat depression, anxiety disorders, or chronic pain more effectively via deep brain stimulation.
More Articles from TRENDS February 2019
THE PERIODIC TABLE OF ELEMENTS
Suggests a link between chemical elements and the provision of health care services in the context of social determinants. Read More
PRESIDENT’S CORNER—ASAHP MEMBER FOCUS
Gregory Frazer, Dean and Professor, Covey College of Allied Health Professions at the University of South Alabama, is featured in this issue of TRENDS. Read More
OPEN SEASON FOR LEGISLATION
The 116th Congress is faced with the challenge of identifying areas of bipartisan agreement in order to pass meaningful health legislation. Read More
HEALTH REFORM DEVELOPMENTS
Discusses the fate of the Cadillac tax in the Affordable Care Act, short-term Association Health Plans in relation to state regulations, and the impact of primary care on reducing health care costs and patient outcomes. Read More
DEVELOPMENTS IN HIGHER EDUCATION
Indicates a mechanism for reducing college student debt and the results of a request for comments on a proposed rule involving Title IX provisions for campus sexual assault allegations. Read More
AVAILABLE RESOURCES ACCESSIBLE ELECTRONICALLY
Adoption Of A National System For Electronic Use And Exchange Of Health Information
Current Status And Response To The Global Obesity Pandemic
How Innovation Will Blur Traditional Health Care Boundaries Read More
IDENTIFICATION, EVALUATION, AND COMPARISON OF HEALTH DEVICES
Provides information about the explosion of health devices in the marketplace aimed at consumers and challenges that confront health professionals attempting to select appropriate technologies that meet the requirements of specific applications for a clinical trial, research study, or a digital health service. Read More
PUTTING PATIENTS FIRST AND DISPARITIES RESEARCH
Refers to disparities in language‐appropriate services in the in-patient hospital setting. Read More