What is European MDR and Why It happened, Timelines for Compliance

First in a 7-part series on the EU’s Medical Device Regulation

For Kapstone Medical

The European Parliament passed the Medical Device Regulation (MDR) two years ago and began a three-year transition period in May 2017 with enforcement set to begin in May 2020.

The new regulation repeals and replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD), effectively pushing the reset button for medical device makers who sell products in Europe. (published site)

Could My Headaches Be Caused By Neck Pain?

For Advanced Orthopedics

Everyone has experienced that dull ache in the neck that eventually becomes a headache. There are many causes and most are not a result of a serious condition, an aspirin or other pain reliever usually does the trick. If you experience these headaches frequently, however, you may want to consult a doctor. (published site)

Is minimally invasive spine surgery for you

For Advanced Orthopedics

If you’ve got chronic back pain that is unrelenting, you probably have seen the ads for minimally invasive spine surgery. The ads make the procedure sound simple, quick and claim that the incision can be closed with just a Band-Aid being applied to the patient’s back.

How digital diagnostics and AI are changing medicine

Orlando Medical News
Ghost writer

A major topic in healthcare right now is the use of digital diagnostics for medical decision-making. Futuristic visions of smartphones, wearable technology, and telemedicine providing continuous monitoring of our health with early, even remote diagnosis of health problems by physicians are often cited when people talk about digital diagnostics.

In reality, current implementations of digital diagnostics are much more about developing a range of diagnostic testing and screening technologies for analyzing, assessing and evaluating a broad range of diagnostic algorithms faster, easier, and more accurately. (published site)

ISASS Reaffirms support for vertebral augmentation for VCFs

For Advanced Orthopedics 

Vertebroplasty and kyphoplasty remain the treatments of choice for patients with painful vertebral compression fractures according to an updated review of literature by an expert panel of the International Society for the Advancement of Spine Surgery (ISASS).

The panel reviewed the body of literature and found an overwhelming body of evidence supporting vertebral augmentation which they published in the International Journal of Spine Surgery.

What Elizabeth Holmes and Theranos Got Wrong About Diagnostics

For Fibronostics

It was a promise too good to be true – a bread maker-sized box that could analyze a single small blood sample for 200 different illnesses and conditions.

The idea was so attractive and the inventor so convincing that such sophisticated investors as media mogul Rupert Murdoch, the Walton family, Betsy DeVos and others invested upwards of $100 million each to get in on the ground floor of what was perceived to be a Silicon Valley startup that would disrupt healthcare the way Apple disrupted mobile phones. (published site)

Spine surgery society makes recommendations for bone graft substitutes

For Advanced Orthopedics

The International Society for the Advancement of Spine Surgery (ISASS) has published a new policy statement on bone grafting. 

An expert panel looked at alternatives to autologous bone grafting (ABG) and reviewed the available literature for five current strategies and techniques for bone grafting and compared them for safety and efficacy. They also compared the methods by regulatory approval pathway and quality of the clinical evidence supporting them. Their findings appear in the Feb. 2019 International Journal of Spine Surgery, the official ISASS journal. (published site)