Edwards Lifesciences has ‘key events’ around TAVR this week

Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway. The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow. Edwards officials expect the Sapien 3 Ultra to receive CE Mark

How Abbott is making good on investor promises

Abbott (NYSE: ABT) has won FDA approval of MR-compatible ICDs – an indication that it could be making good executing on key priorities it inherited when it acquired St. Jude Medical for $25 billion early this year. The news today “lends incremental credibility to our thesis that ABT can and will have a positive impact on STJ

The startup pivot: How to rethink your medical device company

In the medtech market, startups have to be flexible; the startup pivot is crucial. “Companies have to morph as they go,” said Maria Palasis, CEO of bioresorbable drug delivery system company 480 Biomedical. Palasis explained that startups, and even mature companies should expect to shift their technology in one way or another through the course of

How to design a successful embolic protection devices clinical trial

Embolic protection devices could reduce risks of interventional cardiac procedures such as TAVR, but their efficacy is hard to prove. David Novotny, Novella Clinical The embolic protection device (EPD) market is expected to grow into a billion-dollar industry if the device becomes the standard safety protocol for transcatheter aortic valve replacement (TAVR) and other interventional

How Boston Scientific is boosting medical device value

Boston Scientific over the summer unveiled a new value-add for its implantable cardio devices: an online Trugevity calculator that lets physicians predict battery life. The idea is to help health providers quickly grasp the benefits of Boston Sci’s longer lasting EnduraLife battery technology, which the company touts has nine clinical studies and eight years of real-world

Abiomed buys Danvers, Mass. HQ for $17m

Abiomed (NSDQ:ABMD) said this week it inked a deal to purchase its existing corporate headquarters in Danvers, Mass. for $16.5 million. The company said that it opted to buy the facilities, which includes 12 acres of land and all associated buildings, structures and other improvements, through an option in its existing lease with the original owners. Abiomed […]

Apple to launch heart arrhythmia trial with Apple Watch 3

Apple (NSDQ:AAPL) said this week it will partner with telemedicine company American Well and Stanford University to test the performance of its Series 3 Apple Watch to detect heart arrhythmias, according to a Fortune report. The tech giant announced the Apple Heart Study at its iPhone unveiling event earlier this week, saying that the company would […]

LivaNova heater-cooler implicated in 12 pediatric heart surgery infections

A dozen children who underwent cardiac procedures at Children’s Hospital New Orleans earlier this year have been infected with myobacterium previously linked to LivaNova’s (NSDQ:LIVN) 3T Heater-Cooler systems, according to a STAT News report. A total of 55 children had heart surgery between May and July at the facilities, with 7 of the 12 patients […]

Medtech stories we missed this week: September 8, 2017

From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating

Is this the key to rapidly manufacturing heart valves?

Nanofiber fabrication may be the key to rapidly manufacturing heart valves with regenerative and growth potential, according to new research from Harvard University’s Wyss Institute for Biologically Inspired Engineering. A research team led by Kevin Kit Parker created a valve-shaped nanofiber network that replicates the mechanical and chemical properties of the native valve extracellular matrix (ECM).

FDA approves pivotal study of Vascular Dynamics MobiusHD high blood pressure device

Vascular Dynamics said today that the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension. MobiusHD is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors there. Mountain View, Calif.–based Vascular Dynamics said the 300-patient Calm 2 study is designed

Abbott’s new contact ablation catheter: Here’s what you need to know

The new TactiCath contact ablation catheter unites EndoSense and St. Jude Medical technologies that Abbott acquired, marrying fiber optics, flexibility and 3D mapping. If you want your grilled cheese to cook faster, you press it into the pan with your spatula. That’s contact force, the principle behind Abbott’s TactiCath contact force ablation catheter, according to

Integer Holdings: What you need to know

Greatbatch and Lake Region Medical merged nearly two years ago to become Integer Holdings Co., a giant medical device contract manufacturer that could theoretically do almost anything for an OEM. But can this colossus of a company execute on its expanded capabilities? When Greatbatch and Lake Region Medical merged in 2015, company officials decided they

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This artificial heart is made from silicone

Researchers have developed an artificial heart made of silicone that beats almost like a human heart, according to new research from Eidgenössische Technische Hochschule (ETH). The ETH researchers set out to develop a heart that looks like the real time and functions like one too. It was designed by Nicholas Cohrs, a doctoral student in

Could this algorithm be better at diagnosing arrhythmia than cardiologists?

A new algorithm that can go through hours of heart data to detect arrhythmia performs better than trained cardiologists, according to new research from Stanford University. The algorithm gathers data from wearable monitors to find life-threatening irregular heartbeats and allows for data to be sorted through in remote areas where there is a scarcity of