INTRODUCTION

The medical technology industry is constantly evolving and improving, with new devices and technologies being developed all the time. While these advances have the potential to greatly improve patient care and outcomes, it is important to ensure that these devices are safe and effective before they are made available to the public. So, here is a recap of the key FDA approvals in January 2023.

1. Vivos bounces back from FDA rejection to land 510(k) clearance for sleep apnea treatment

Vivos Therapeutics has received 510(k) clearance of a daytime-nighttime appliance, known as a DNA appliance, for the treatment of obstructive sleep apnea after a second attempt to win approval.

The DNA device is part of a set of products intended for use in a procedure to expand the palate and train the tongue to rest in the “proper position.” By doing so, Vivos thinks it can convert patients to nasal, as opposed to oral, breathing by addressing the root cause of OSA, and thus provide an alternative to continuous positive airway pressure machines.

The U.S. Food and Drug Administration had earlier rejected an application for the product in 2021 but has now reversed its ruling.

“For the first time, the FDA has formally recognized the benefits of our proprietary core technology in our DNA appliance (without mandibular advancement) as an effective treatment for mild-to-moderate OSA in adults,” Vivos CEO Kirk Huntsman said in a statement.

2. Tidepool lands long-awaited FDA nod for artificial pancreas app connecting CGMs, insulin pumps

More than two years after submitting it for FDA review, Tidepool has scored the agency’s clearance for a smartphone app that allows people with Type 1 diabetes to build their own closed-loop “artificial pancreas” system.

The app connects wirelessly to certain continuous glucose monitors and insulin pumps that are compatible with alternate controllers. From there, rather than managing each device separately and manually updating insulin dosages, users can monitor both devices in one place, and the app automatically tweaks basal insulin doses based on CGM readings. Loop’s algorithm can also predict spikes in glucose and recommend correction doses of bolus insulin—which users have to manually accept.

“We knew this day would come, but we couldn’t have achieved it without the support of the entire diabetes community, including the FDA,” CEO Howard Look said in a company announcement Tuesday, offering his specific thanks to the “DIY” diabetes community and all participants in clinical studies of Loop. The technology was cleared for all Type 1 diabetes patients aged 6 and older

3. Realize Medical clears FDA hurdle for better VR surgical planning software

Ottawa-based start-up Realize Medical Inc. reported U.S. FDA clearance of virtual reality (VR) surgical planning software to help physicians create and share complex patient anatomy from CTs and MRIs in an immersive 3D environment.

The company said in a news release that FDA clearance marks “a significant milestone.”

“We’re often told that Elucis represents the most advanced offering in the mixed reality space,” said Realize Medical CEO Justin Sutherland. “But with powerful image processing, modeling, and collaboration tools, it’s also a comprehensive and complete platform for serving the full suite of growing 3D needs in medicine. With FDA clearance, we’re truly excited to enable an expanding era of procedure planning and collaboration.”

4. First 4K single-use surgical arthroscope wins FDA clearance

The FDA-cleared Summit is a first-of-its-kind 4K single-use surgical arthroscope designed to improve the efficiency, consistency, and safety of arthroscopic procedures. Summit combines a 4K single-use surgical arthroscope with cloud-based software – Pristine Connect™ – to deliver a high-definition image, every time, with a device that is always new and never obsolete.

The scope is simple to set up and 100% sterile, ensuring patient and staff safety. Its transparent pricing model and automated inventory management also improve predictability and workflow.

“The Summit single-use arthroscope represents a new paradigm in arthroscopy, improving a procedure that hasn't changed much in my 42 years of practice and beyond," said Dr. Stephen Snyder, chief medical officer of Pristine Surgical and a recognized pioneer in the field of arthroscopy. “We’re removing the well-known barriers of legacy, reusable systems that eventually become obsolete by offering a new 4K single-use scope that improves safety and reliability while decreasing room turnover time and the cost of arthroscopic treatment.”

5. Abbott receives FDA approval for diabetic peripheral neuropathy device

Abbott announced today that the FDA has approved its Proclaim™ XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. The Proclaim XR SCS system can provide relief to DPN patients in need of alternatives to traditional treatment approaches, such as oral medication. People who receive therapy from the Proclaim XR SCS system will also be able to use Abbott's NeuroSphere™ Virtual Clinic, a connected care app that allows people to communicate with a physician and receive treatment adjustments remotely.

"As a leader in diabetes care, Abbott is intimately familiar with the challenges people with diabetes encounter daily. This new indication for Proclaim XR will drive meaningful change in the treatment of pain associated with diabetic peripheral neuropathy and will be an important tool for physicians and patients in managing this debilitating condition," said Pedro Malha, vice president, neuromodulation, Abbott.