How creative FDA regulation led to first-in-the-world approval of a cutting-edge heart valve

Dr. Jeffrey Shuren and Dr. Bram Zuckerman Nearly six years ago FDA approved an artificial transcatheter heart valve (THV) to treat patients having severe symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms, or cardiac arrest, because one of the valves in their heart (the aortic valve) was no

Analysis: Here’s why medtech should feel optimistic about 2017

Uncertainty continues to swirl around the new Trump administration, but there is a lot to be excited about in the medical device industry these days, especially when it comes to cardiology and diabetes treatment. Medtech companies are performing well. More than 80% of the world’s 100 largest medical device companies saw their stock values increase

Cardiology research breakthroughs you need to know

Recent months have seen a host of important cardiology research breakthroughs related to new cardio devices and diagnostics, tissue engineering and the overall understanding of heart disease and its treatment. For example,  a customizable robotic heart sleeve – developed at Harvard University and Boston Children’s Hospital – has demonstrated advantages over other heart assist devices

Battery-free pacemaker successfully powers the heart

A wireless, battery-free pacemaker has shown success in powering the heart in pig models, according to researchers from Rice University and the Texas Heart Institute. The pacemaker, designed by lead researcher Aydin Babakhani, gets its energy wirelessly from radio frequency radiation transmitted from an external battery pack a few centimeters away. Pacemakers are small battery-powered

Abbott heart device shown safe for infants

Developing very small devices that can be used for children is a significant challenge in the market. FDA is cautious to approve new devices into this market for vulnerable patients. But the efforts are needed to improve the health of babies, particularly those born with heart defects. Abbott’s reduced sized Amplatzer duct occluder II (ADO

Reanimating human hearts: Ohio State is taking it to the next level

Ohio State University researchers have figured out a way to reanimate human hearts in order to gain a better understanding of irregular heartbeats. “It’s amazing. You can see the heart start beating again, which gives us an opportunity to study it with high-speed, high-tech equipment,” said Vadim Fedorov, an OSU biologist who developed the technique,

Here is Boston Scientific’s plan to win in medtech

When it comes to Boston Scientific succeeding in the medical device industry, CEO Mike Mahoney says it is about “category leadership.” Health providers, especially in the U.S., are consolidating, so Boston Sci needs to persuade hospital system officials that their products are the best in particular areas. “Category leadership is everything. Hospitals – whether you’re in Korea

Abbott’s MitraClip can be implanted through the jugular vein, too

A Canadian cardiologist has successfully inserted Abbott Labs’s MitraClip through the jugular vein instead of the femoral vein, according to a recent report. Dr. Neil Fam inserted the Abbott Laboratories device into an 86-year old patient with severe mitral regurgitation. Because of the patient’s age, traditional surgery to repair her mitral valve was not an

Researchers find 8k cyber vulnerabilities in pacemakers

Researchers from the security research firm WhiteScope identified cyber vulnerabilities in file system encryption and in the storage of unencrypted patient data across major vendors of implantable cardiac devices, according to the team’s report. “The findings reveal consistency across all vendors, highlighting the inherent weaknesses in the ecosystem architecture,” the firm wrote. Get the full story

Mechanical heart valves are so loud that they cause insomnia

A quarter of patients with mechanical heart valves claim that the valves disturb their sleep, according to a new study. “For some patients, the closing sound of their mechanical heart valve reduces their quality of life, disturbs their sleep, causes them to avoid social situations and leads to depression and anxiety,” said Kjersti Oterhals, a

Artificial intelligence accurately predicts stroke risk

Machine-learning algorithms, a form of artificial intelligence, accurately predicted people’s risk of heart disease and stroke, according to new research from the University of Nottingham. Researchers and computer scientists compared the risk guidelines for heart disease and stroke from the American College of Cardiology with 4 machine-learning algorithms to analyze the risk of a patient

What is catheter (PTCA) treatment?

Asahi Intecc Catheter treatment (percutaneous transluminal coronary angioplasty, or PTCA, treatment) is one of the methods of treatment for diseases such as angina pectoris and myocardial infarctions that are caused by the heart’s blood vessels (coronary arteries) becoming clogged or narrowed by cholesterol. Previously it was common to treat such diseases with medication or, if

Deaths prompt Abbott recall of Thoratec HeartMate II controllers

Brad Perriello, Executive Editor Abbott (NYSE:ABT) is recalling nearly 29,000 controllers for the HeartMate II implantable heart pump made by its Thoratec subsidiary after 26 patients died trying to change out the controllers on their own. The March 29 recall of 28,882 controllers for the HeartMate II left ventricular assist device follows 70 reports of

This could be the battery-free solution for pacemakers

A new energy storage system charges itself using ions from inside the human body – providing an exciting alternative to traditional batteries used in pacemakers, according to researchers at the University of California at Los Angeles and the University of Connecticut. Researchers at the universities developed a bio-friendly energy storage system called a biological supercapacitor;

Apple Watch detects atrial fibrillation using built-in technology

The Apple Watch can automatically detect atrial fibrillation (AF) using its built-in heart rate sensor and artificial intelligence, according to a new study. The research used a deep neural network that was based on photoplethysmographic (PPG) sensors that are frequently found in smart watches. When paired with an artificial intelligence-based algorithm, Apple Watch’s heart rate