Don’t Put That in My Heart Until You’re Sure It Really Works

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.

 Pacemakers have thousands of vulnerabilities hackers can exploit, study finds

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.

 Should Your Watch Monitor Your Heart?

Apple’s new watch can screen for heart problems. But doctors are increasingly worried about the dangers of testing healthy people for disease.

Going Out With a Bang

As pacemakers and other implantable devices become more common, so are crematoria explosions.

Medical Devices Are the Next Security Nightmare

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.

Please Step Aside, Sir

My medical devices help keep me alive—and subject me to uncomfortable scrutiny every time I pass through airport security.

Replacing Faulty Heart Devices Costs Medicare $1.5 Billion in 10 Years

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.

A Cardiac Conundrum

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.

Advances in Treating End-Stage Heart Failure: VADs, ECMO & Total Artificial Heart

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's iPad 2 may interfere with heart devices, 14-year-old researcher finds

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?

FDA-Approved Devices That Keep the Heart Beating

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.

My Pacemaker Is Tracking Me From Inside My Body

Cloud-connected medical devices save lives, but also raise questions about privacy, security, and oversight.

The Most Promising New Heart Devices

When drugs fail, new surgical procedures and devices can help.

Wearable Health Monitors: Do They Work?

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.

When Evidence Says No, but Doctors Say Yes

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.