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June 7, 2022

US FDA grants 510K clearance for Aurora Spine’s interbody fusion device

The DEXA SOLO-L ALIF device allows doctors to match the implant to patients' bone density and quality.

The US Food and Drug Administration (FDA) has granted 510K clearance for Aurora Spine’s DEXA SOLO-L anterior lumbar interbody fusion device (ALIF).

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Based on the company’s DEXA Technology Platform, the 3D printed standalone device has been designed for anterior and lateral lumbar interbody fusion (ALIF & LLIF) procedures.

The DEXA SOLO-L spinal fusion system was developed as a bone density matched implant and is claimed to be the first device of its kind for the lumbar spine.

It is also the first colour-coded, bone mimicking ALIF standalone device on the market, enabling doctors to match the implant to a patient’s bone density and quality.

Aurora Spine president and CEO Trent Northcutt said: “We are thrilled to receive this new approval for our DEXA SOLO-L device, the world’s first patented and FDA-cleared, colour-coded ALIF standalone device.

“This clearance is an important step to gain new surgeon customers and new sales distribution opportunities nationwide to drive more revenue.”

The company claims that its DEXA implants are the world’s first implants that match patient bone density and quality to provide a personalised implant.

The launch of the DEXA-L product line follows the recent release of the DEXA-C cervical implant product line.

Aurora Spine chief technology officer Laszlo Garamszegi said: “The DEXA SOLO-L approval demonstrates our unwavering commitment to game-changing innovation around our entire bone mimicking DEXA Technology Platform.

“We will continue developing proprietary products to strengthen our product offerings, and build off our patent portfolio, especially our patented DEXA Technology Platform.”

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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