Monday, July 22, 2019

Physician Tips: What is the Future of Wearables in Healthcare?

Fourth in a series on wearable healthcare devices


The future of medical wearables is bright by all counts, the market is expected to reach $100 billion by 2027, according to market research and business intelligence firm IDTechEX. What is less certain is what impact these devices will have on healthcare. (published site)

Monday, July 15, 2019

Physician Tips: What Wearables Are Being Used Now For Healthcare

For Fibronostics

Third in a series about the development of wearable medical devices

One of the challenges of making wearable medical devices clinically useful is making sense of the deluge of data these devices can generate and more importantly extracting relevant and actionable information for clinical decision-making. (published site)

Decompression of Lumbar Spinal Stenosis Using iO-Flex® MBS Device

Patients with severe lower back pain due to narrowed passages for spinal nerves obtained sustained significant relief with a new, minimally invasive procedure, a new study shows.[1]

The new procedure uses a flexible rasp-like device to remove bone and tissue to enlarge the opening, called the foramen, where nerves exit the spinal canal and extend to the limbs. The new device, called iO-Flex® allows the surgeon to remove just enough bone to open up the passageway and take the pressure off the nerve without removing so much bone that the spine becomes unstable.
(published site)

Monday, July 8, 2019

Physician Tips: How Are Wearables Are Disrupting Healthcare




For Fibronistics

Second in a series on wearable healthcare devices

Imagine a future where the clothing and accessories continuously send health-related data for your patients to their own patient-specific databases. The data is monitored by artificial intelligence that can distinguish between an anomaly that is little more than a blip, and one that may be cause for alarm. An alert is sent to a data analyst, who determines whether diagnostic testing is warranted, if so a consultation with you is arranged. (published site)

Tuesday, July 2, 2019

How Clinical Evidence Requirements Affect Medical Device Approvals

For Kapstone Medical

Part 5 in a 7-part series on the EU’s Medical Device Regulation

Among the significant changes facing device makers transitioning their products in the European Union from the Medical Device Directives (MDD) to the Medical Device Regulation (MDR) are the new requirements around clinical evidence. (published site)
Under the MDR, device manufacturers marketing products in the EU will face some additional hurdles, but if you also market in the US, Canada, Japan, or other countries, the new regulations will likely be familiar to you.

The big shift in the EU’s MDR is toward a much greater emphasis on ensuring a high level of health and safety protections for EU citizens.

Monday, July 1, 2019

Physician Tips: What Are Wearables and How Are They Used In Healthcare?

For Fibronostics


First in a series looking into the potential impact of wearable medical devices on healthcare

Drop the term wearable health devices and most people think of Fitbit or the Apple watch, but wearable health tech is much more than a new class of consumer products. (published site)

Friday, June 21, 2019

Product Portfolios and Technical Documentation

For Kapstone Medical
Part 4 in our 7-part series on meeting the new requirements under the EU MDR

Complying with the European Union’s Medical Device Regulation (MDR) poses a daunting task for medical device makers marketing products inside the EU. One of the most taxing efforts for companies that already have CE-marked devices in the EU is the need for portfolio reviews. (published site)


Tuesday, June 18, 2019

Patients Achieve Significant Relief with Minimally Invasive PCF

For Advanced Orthopedics

Patients who underwent Posterior Cervical Fusion (PCF) and decompression obtained significant clinical improvement with high fusion rates and low revision and complication rates, and patient reported outcomes matched and, in some cases, exceeded the clinical results, according to a new study. (published site)

Monday, June 17, 2019

Physician Tips: Engagement Marketing For Improving Patient Compliance


Faced with performance-based reimbursement and growing pressure for improving outcomes, physicians are looking for ways to improve their patient communications and education in order to engage them and activate them for better health. (published site)

Notified Bodies

Part 3 in our 7-part series on meeting the new requirements under the EU MDR

If you are new to obtaining marketing approval in the European Union, the concept of Notified Bodies is one of the most significant differences from the US FDA system or regulatory oversight.


A Notified Body is an independent certification organization that is “notified” by an EU member state’s Competent Authority, usually the ministry of health, to certify that a product meets the applicable requirements for CE marking.

Friday, June 7, 2019

How do we get ready for MDR?

For Kapstone Medical

High level areas to consider

Second in a 7-part series on the EU’s Medical Device Regulation
The new Medical Devices Regulation (2017/745/EU), or more commonly referred to as the EU MDR, poses significant challenges to medical device makers that want to market their products in the European Union. (published site)

Thursday, May 30, 2019

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)

Monday, May 20, 2019

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)

Tuesday, May 14, 2019

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.

Friday, April 26, 2019

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)

Thursday, April 11, 2019

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.

Friday, March 22, 2019

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)

Thursday, March 14, 2019

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)

Friday, March 1, 2019

A group of international radiology societies take aim at AI ethics

For PARCA 

PARCA eNews – Mar. 1, 2019 – The American College of Radiology, European Society of Radiology, Radiology Society of North America, Society for Imaging Informatics in Medicine, European Society of Medical Imaging Informatics, Canadian Association of Radiologists, and American Association of Physicists in Medicine collaborated on a 34-page draft statement concerning ethical issues surrounding the use of AI in radiology.

The preliminary draft has not been endorsed by any of the sponsoring societies, rather the draft was published to spur debate and discussion among all interested parties, who are encouraged to submit comments by April 7, 2019. (published site)

Monday, February 4, 2019

Give Hydrotherapy A Try To Ease Your Chronic Back Pain

For Dr. Gomez | Feb 4, 2019 

Living in Florida with pools and spas literally everywhere, I’m often asked whether water exercise might be better for back pain than other forms of exercise. (published site)

Wednesday, January 2, 2019

Hip, spine? Where is the pain coming from?

For Dr. Gomez | Jan. 2, 2019

If you have been referred to a specialist for your hip or back pain, it is likely that pinpointing the source of your pain may take some time, and you’re not alone. Pain that seems to be in both the hip and spine is a common complaint, so much so it is sometimes referred to as “hip-spine syndrome.” (published site)