SAN FRANCISCO — In the past, medical device companies may have gotten away with waiting until later in the development process or even late into the regulatory process to start thinking about reimbursement. Today, thinking upfront about who will pay for the device and how it will be reimbursed is critical, according to a panel of experts at the OneMedForum meeting.

SAN FRANCISCO — When it comes to confronting disappointing news, Medtronic (Minneapolis) CEO Omar Ishrak is not one to beat around the proverbial bush. At the 32nd annual J.P. Morgan Healthcare Conference in San Francisco, Ishrak made a point to address upfront the recent news that the company's U.S. pivotal trial in renal denervation for treatment-resistant hypertension failed to meet its primary efficacy endpoint.

Being able to breathe during sleep is something most of us take for granted. But for the millions of patients in the U.S. suffering from sleep apnea, their sleep cycle is routinely interrupted by episodes of apnea, meaning they stop breathing for a minute or longer. These repeated episodes of apnea usually leads to daytime fatigue and it increases a person's risk of heart attack, stroke, high blood pressure, and even death.

Delphinus (Plymouth Township, Michigan) said it has received FDA 510(k) clearance for its SoftVue whole breast ultrasound tomography system, approved for diagnostic breast imaging.

In reviewing Medical Device Daily's top stories and industry trends that emerged over the past year, the familiar words of Charles Dickens seems to be an appropriate way to describe the state of the industry in 2013: It was the best of times, it was the worst of times. The medical device sector underwent immense change in 2013, and while it may be easier to think of the negative headlines that impacted the industry over the past 12 months, there were a number of positive trends that emerged last year. For better or for worse, 2013 was a transformative year for medical technology worldwide.