Sometimes its good to remind ourselves of the impact that can be had on patients.

UK resident Joanne Milne was born deaf. She suffers from a rare condition known as Usher Syndrome, a genetic disorder that leads to blindness and deafness. About a month ago Milne received cochlear implants, but has had to wait four weeks for the devices to be activated.

Her mother was on hand to document the powerful and emotional moment when Milne heard for the first time.

 

 

Head to Birmhingham Mail to read more of Milne's story.

...
March 28th, 2014
0

FDA's new recall review indicates that medical device companies are more diligent about reporting. But there's still a lot of room for improvement.

                                 

Upon the recent release of FDA’s "Medical Device Recall Report: FY2003 to FY2012," headlines blared the fact that recalls—particularly Class I recalls—have skyrocketed over the past decade. While not inaccurate, the negative slant of these...

March 28th, 2014
0

 

As a hospital, would you buy your pacemaker and defibrillator online, much like you would a book or a small electronics or diapers from Amazon? 

Swiss startup NayaMed, which launched a few years ago, is betting that hospitals will. At least those in Europe. The company's website shows that hospitals in Italy and Germany are using the company's online platform to source products.

But NayaMed does more than provide an e-marketplace. It offers 24-hour access to digital inventory management, communities, eLearning, product information and technical support. 

The medical device purchasing process is...

March 26th, 2014
0

Medtech companies are chafing under unprecedented pricing pressures from hospitals. A recent survey report from L.E.K. Consulting that annually polls hospital CEOs should serve as a wake-up call to the medtech industry to look for innovative ways to partner with hospitals instead of ...

March 26th, 2014
2

 

In a letter to FDA commissioner Margaret Hamburg, a bipartisan group of senators asks what impact congressional legislation might have on FDA regulation of mobile medical apps and medical software. The March 18 letter urges FDA to be more clear and transparent in its guidance on mobile medical apps. The group, which consists of senators Michael Bennet (D-CO), Tom Harkin (D-IA), Richard Burr (R-NC), Orrin Hatch (R-UT), Lamar Alexander (R-TN), and Mark Warner (D-VA) applaud FDA for taking a risk-based approach in defining how it will regulate medical mobile apps because doing so will allow a large number of applications to be actively regulated. However, they stress that “more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated.”

...
March 21st, 2014
0

device_cost, pricing_transparency

An upstart tech startup determined to bring much-needed price transparency to the hospital purchasing environment just got $4 million in Series A funding.

You can count that every dollar will go toward evening out the playing field when it comes to negotiating hospital purchasing agreements of medical devices.

And rightly so, given that hospital executives all the way to the GAO have found price transparency to be conspicuous by its very absence in such negotiations.

That’s where Procured Health, the Chicago startup, comes in. On Thursday, FCA...

March 21st, 2014
0

The Class I recall of McKesson's Anesthesia Care software provides clues as to what FDA considers to be high-risk clinical decision-support software and high-risk bugs.

By Bradley Merrill Thompson

On March 14, 2014, FDA notified healthcare professionals of a Class I recall that McKesson initiated in 2013 of its Anesthesia Care software. Because FDA rarely issues a recall notice of that nature with regard to standalone software—software that does not play a role in operating a medical device—there are some important insights about FDA’s stance on clinical decision-support software (CDS) that we can derive from its action. 

The recall classification gives us some clues as to what FDA considers to be high-risk clinical decision support software, and high-risk bugs that might be...

March 20th, 2014
0

A few weeks ago, Aetna CEO Mark Bertolini announced at the annual HIMSS conference that the insurance company was collaborating with medical device maker on heart failure and diabetes.

It’s a novel collaboration and underscores how the healthcare industry is undergoing unprecedented shift. Aetna is of course keen to bend the cost curve of healthcare and manage its own expenses, which necessarily means keeping a handle on chronic diseases such as heart failure and...

March 18th, 2014
0

There's been a lot of speculation around Apple's plans to enter the healthcare space very soon. Health tracking capabilities built into the iPhone 5's M7 chip, a number of high-profile hires, and rumors of the company developing its own “iWatch” for health monitoring have fanned flames that Apple wants a piece of the mhealth and digital health space.

Recreations of leaked images of Apple's Healthbook app show a variety of health monitoring features. [...
March 17th, 2014
0

Misconduct in scientific research dates back to Ptolemy in 2nd Century A.D. who declared that he had recorded measurements - which he couldn't possibly have - to show that the earth was at the center of all celestial bodies, including the sun.

But Ptolemy's grand declaration didn't exactly harm anyone. That isn't the case with misconduct in medical research, however.

In fact, orthopedics experts and journal editors at the 81st annual meeting of the American Academy of Orthopaedic Surgeons in New Orleans Wednesday said they are concerned by the fact that misconduct in medical research has been on the rise in recent years.

In 2012, there were 2047...

March 12th, 2014
0