The bar for approval of medical devices is too low. There is no reason we shouldn’t require, as we almost always do for drugs, a randomized placebo-controlled trial showing improvements in “hard” outcomes like mortality before approving them.
Unfortunately, the United States may soon make it even easier for medical devices to reach the patient’s bedside.
There are a lot of devices that don’t need to be connected to the internet. Toasters don’t need to be connected to the internet. Neither do juicers, door locks, or rectal thermometers. Pacemakers were around for at least 40 years before someone got the bright idea to expose them to the information superhighway, a move that does indeed help doctors assist patients, but it comes with great risk.
Apple’s new watch can screen for heart problems. But doctors are increasingly worried about the dangers of testing healthy people for disease.
As pacemakers and other implantable devices become more common, so are crematoria explosions.
Implanted medical device hacks are so memorable because they're so personal. You wouldn't want something inside your body or on your skin to be remote-controlled by a criminal. Unfortunately, many types of these devices are broadly vulnerable to attack.
My medical devices help keep me alive—and subject me to uncomfortable scrutiny every time I pass through airport security.
The report marks the first effort by anyone in government to assess the losses to taxpayers and patients 65 and older from medical gear that proves faulty.
Officials said the $1.5 billion lost from the seven devices from 2005 through 2014 was a “conservative estimate.” Patients also paid $140 million in out-of-pocket costs for this care, the report noted.
In his new book, Broken Hearts: The Tangled History of Cardiac Care (Johns Hopkins), David S. Jones ’92, M.D. ’97, Ph.D. ’01, Ackerman professor of the culture of medicine, narrates the history of two of American medicine’s highest-profile treatments for heart disease: coronary artery bypass grafts and angioplasty.
Previously, heart transplantation was the only hope for those with end stage heart failure. Now, with VADs (Ventricular Assist Devices), ECMO (machines providing short-term heart and lung support) and the Total Artificial Heart, patients have a wider range of options.
Apple iPads are everywhere these days, from schools with small children to bedside tables where adults enjoy a good read before they go to sleep.
But, can they be unsafe for some individuals?
Heart devices such as pacemakers and defibrillators have extended and improved the lives of millions of people worldwide.
The Food and Drug Administration (FDA) helps provide access to heart devices that use the latest science and technology, through approval and oversight processes that expedite the availability–and assure the safety–of the products.
Cloud-connected medical devices save lives, but also raise questions about privacy, security, and oversight.
When drugs fail, new surgical procedures and devices can help.
The explosion in smart devices—phones, watches, fitness gadgets and the like—has unleashed a wave of apps designed to manage chronic illnesses, detect behavioral diseases and manage pain. Most recently, Apple announced that apps due later this year will allow its Series 4 watches to perform electrocardiogram readings, or ECGs, and notify users of irregular heart rhythms. The problem for consumers is knowing which apps—if any—actually work.
Long after research contradicts common medical practices, patients continue to demand them and physicians continue to deliver. The result is an epidemic of unnecessary and unhelpful treatments.
What better use for an app, which you carry with you constantly, than to provide information about a device that is implanted in you permanently? For the nearly 100,000 valve replacement patients (and their health care providers), the yet to be developed MyValve app could show the size, model, and manufacturer of the valve, in addition to the implanting institution, name of the surgeon, reason for valve replacement (or repair), and information about their disease. There is already tons of information about the devices on these companies' websites so why not allow them to read it on their phone or tablet?
New cardiovascular device therapies for atrial fibrillation (AF) and heart failure (HF) are rapidly evolving with the use of innovative materials and new technologies.
Our purpose is to help cardiac pacemaker and implantable cardioverter defibrillator (ICD) recipients meet, share information and support each other.
You may currently have a heart device, or you may have been told by your doctor that you could potentially need a heart device sometime in the future. Boston Scientific makes a wide range of devices that will help protect you and your heart.