GE's Healthcare business is rebounding and its equipment orders suggests that that there is some stability in U.S. hospital capital spending that may even be improving.

Arundhati Parmar

On Friday, GE reported its first quarter earnings and while its oil and gas business faces challenges, the diversified company had strong performance in other businesses including healthcare.

In fact, following the company's earnings call, one analyst wrote that it was GE's Healthcare business "posted the best organic growth in 20 quarters." Certain conclusions about the health...

April 22nd, 2016
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Agile methodologies for software development offer a number of benefits for medical device companies. Here are some best practices for making the transition.

Clark Fortney and Rainy Mumper

Many industries and companies have seen the benefits to developing software using Agile methodologies instead of following a more traditional waterfall approach. In the highly regulated world of medical device development, there is sometimes hesitation by companies in adopting Agile methods for software development due to concerns over how process control and safety can be assured. Acceptance of appropriate Agile methods for medical...

April 21st, 2016
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The North Carolina company had communicated far and wide that FDA would clear its surgical robot, ushering in a new robotics era. Except the agency didn't. 

Arundhati Parmar

It's not often that I repeat a headline in a story, but this one is worth hearing again: It ain't over until the fat lady sings.

In a news release Wednesday, surgical robotics company TransEnterix dropped this bombshell: FDA had turned down its FDA 510(k) clearance for the SurgiBot. The FDA clearance was being viewed as a watershed moment given that it would bring Intuitive Surgical's long, solo reign atop of the surgical...

April 20th, 2016
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The medtech company has been hurting because it doesn't have a MRI-compatible cardiac device in the U.S., and now the first launch is delayed. 

Arundhati Parmar

One big reason that St. Jude Medical's cardiac rhythm business has been losing ground in the U.S. recently is that it doesn't have pacemakers and ICDs that are safe to use under MRI.

Medtronic has its Advisa MRI and Revo MRI pacemakers that are MR compatible, which means patients implanted with those devices are no longer prevented from undergoing MRI scans because of fears that the MRI machine and the implanted device would interact. The Irish medtech company also has the Evera implantable cardioverter defibrillator (ICD) that can be safely used under MRI.

By...

April 20th, 2016
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Johnson & Johnson is facing competition from new insulin pump makers and that is having an effect on prices of its devices. 

Arundhati Parmar
 

Johnson & Johnson reported its first quarter financial performance Monday, and while it medical device business grew after adjusting for acquisitions and divestitures, one segment is facing challenges.

That's the consumer-facing medtech diabetes business, explained CEO Dominic Caruso, in a conference call with analysts.

In the first quarter, the J&J's...

April 20th, 2016
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An executive at a high-volume hospital explains why at his institution, each physician is aware of profit and loss measures.

Marie Thibault

The language of Wall Street trading floors and corporate boardrooms has come to the doctor's office and hospital surgery suite.

It may surprise patients to know that their physicians may be keenly aware of how much a medical device costs, what the device's reimbursement level is, and whether a certain procedure is profitable or not. After all, doctors have historically focused solely on the business of healing. 

But, as Marvin Konstam, MD, chief physician executive at ...

April 19th, 2016
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See IBM Watson Health's Big Data abilities in a live demo at the MD&M East Conference in June in New York. 

Anyone interested in understanding how big data can be harnessed as a predictive diagnostic tool?

If so, they should head over to MD&M East where IBM Watson Health's Kathy McGroddy-Goetz will do a live demo of the supercomputer’s ability to sort through piles of raw data to provide real-time information. McGroddy-Goetz, vice president, Partnerships & Solutions at the standalone health unit of IBM, will do the demo on June 14 at the Jacob Javitz Convention Center in New York. The MD&M East Conference runs June 14-16.

The goal is to show how artificial intelligence can...

April 18th, 2016
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Fractyl Laboratories obtains CE Mark for an ablation device that aims to transform how diabetes patients maintain glycemic control.

Arundhati Parmar

A startup that tackles the problem of type 2 diabetes through an endoscopic procedure announced Friday that it has received CE Mark.

Fractyl Laboratories has developed the Revita duodenal mucosal resurfacing (DMR) system that uses thermal ablation to ablate a portion of the duodenum mucosa, which executives believe can improve glucose control in patients struggling to manage the disease.

In addition to announcing the CE Mark, the Waltham, MA, company also presented data from a first-in-man study that showed that ...

April 18th, 2016
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Patients injured by medical devices have stepped up their attack on CDRH director Jeffrey Shuren, appealing to Congress to fire him.

Jim Dickinson

The unprecedented, coordinated attack by medical device-injured patients on CDRH director Jeffrey Shuren, first reported here last December, has moved from his email inbox to Capitol Hill in the form of an Internet petition to have Congress fire him for, among other things, putting industry concerns before patient safety.

This coincided with an aggressive inquiry from Minnesota Democrat Al Franken with a closely parallel focus, citing concerns ...

April 18th, 2016
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Pulmonx is working to get its Zephyr endobronchial valve, which has already been used in more than 10,000 emphysema patients, approved by FDA.

Nancy Crotti

Pulmonx's Zephyr endobronchial valve, approved in 41 countries but not yet in the United States, is intended to make it easier for emphysema patients to breath.

Patients with severe emphysema haven’t had many options besides dangerous surgery to remove diseased portions of their lungs. Soon, they may have a handful of minimally invasive treatments available, thanks to competition among medtech companies racing for FDA approval.

One of the diseases that falls under the umbrella of chronic obstructive pulmonary disease (COPD), emphysema is characterized by damage to...

April 15th, 2016
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