The spine and medical device industries haven’t slowed down for the holidays just yet. Among a plethora of exciting news in spine and medical devices, here are five of the most popular stories in these crucial topic areas for early and mid-November:
Tim Cook Discusses Apple and Medical Devices
In a recent interview with UK’s Telegraph, Apple CEO Tim Cook discussed the company’s future medical device plans. Although he doesn’t see the Apple Watch turning into a medical device anytime soon (citing FDA clearance and approval difficulties), he has not ruled out the possibility of Apple diving into the medical device business. Ideas include an app or some other component adjacent to the Apple Watch, but not the watch itself. His current focus? Developing non-PC devices in general, and cybersecurity.
FDA Sees Record-High PMA Approval Rate for 2015
The FDA’s Center for Devices and Radiological Health (CDRH) has approved nearly every Premarket Approval Application (PMA) it received for medical devices in 2015. The spike in approvals may be linked to FDA’s improved assessment of PMA deficiencies earlier in the review process. The 98% approval rating is the highest observed in the last 15 years, and is 8% higher than in 2005, which recorded a 90% approval rating.
First Surgery using HA enhanced Lumbar PEEK Interbody technology announced
In other news this month, our company, through press release, confirmed the first surgery using their unique HA enhanced Lumbar PEEK Interbody technology, our signature EVOS-HA. EVOS-HA is the first FDA cleared PEEK-OPTIMA Lumbar Interbody system in the US to be impregnated, not just coated, with Hydroxyapatite (HA). The innovative compound encourages bone growth while providing the strength, versatility, and advantages of its proven predecessor, PEEK-OPTIMA Natural.
Dr. Timothy Bassett of Northport Medical Center in Tuscaloosa, Alabama, performed the first EVOS-HA surgery in the United States on October 21, 2015, for an L4-L5 revision of a failed titanium cage and a non-union in addition to a L5-S1 TLIF.
Six Trends for Spine ASCs Emerge
A new study has examined the utilization of ambulatory surgical procedures for intervertebral disc disorders and spinal stenosis from 1994 to 2006 in the United States. It found that procedures for intervertebral disc disorders have increased 540 percent from 1994 to 2006; during the same time period, procedures for spinal stenosis increased 926 percent. Read more findings regarding the study by clicking the link above.
New wearable device offers insight into spine surgeons’ point of view
UK medical researchers are testing a Google Glass-like device that provides surgeons with patient information in real time, keeping their eyes on critical patient data while performing procedures. The device consists of an optical, head-mounted display, equipped with an exterior-facing camera. Currently, surgeons must learn patient information from colleagues outside the operating room. Spine surgeons and wearable researchers hope that the device can improve accuracy and precision while performing both routine and complicated spine surgeries.
Interested in learning more about cutting edge spine technologies and the spine industry? Click to learn more about our EVOS-HA referenced above, and click here to read even more insightful CES blogs.