Monday, July 22, 2019

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

Fourth in a series on wearable healthcare devices for Fibronostics

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)