INTRODUCTION

Innovation is always key in MedTech. There is a constant need for progression within research and development of MedTech devices. This month saw various MedTech products receive FDA clearance, further improving early detection, monitoring and patient care. 

1. Zimmer lands 510(k) clearance for 3D-printed cementless knee replacement

Zimmer has been building out its cementless portfolio for years, securing FDA clearance for the Persona Trabecular Metal Tibia in 2018 and now adding a 3D-printed product to its arsenal.

Zimmer has pitched its latest product as having optimized fixation, rotation, and stability. Using anatomical data, the MedTech company has sought to reduce micromotion and improve bone coverage. The porous OsseoTi technology is designed for biological fixation.

Ivan Tornos, chief operating officer at Zimmer, outlined the perceived benefits of giving surgeons the option to perform cementless and cemented procedures. “Adding the Persona OsseoTi Keel Tibia to our well-established and clinically proven Persona Knee System allows surgeons to better address the needs of their patients with a comprehensive single system solution for a cementless or cemented application,” Tornos said in a statement on Zimmer’s website.

2. Aidoc Secures New FDA Clearances Enabling Faster and More Accurate Detection of Critical Neurological and Cardiovascular Conditions

Aidoc, the leading provider of healthcare AI solutions, announced it has increased its FDA clearances to 11 with the addition of CT-based AI solutions - aortic dissection and all vessel occlusions. Aidoc's clinical AI improves clinician efficiency, decreases the length of stay, and reduces turnaround time to mitigate average hospital costs, rising 15-25% since 2020. 

“Our continued momentum with FDA-cleared solutions are not only aiding radiologists to prioritize potential findings, but we are helping connect other care team members immediately to the data needed to drive next actions and an optimized care plan. This leads to improved patient outcomes, such as reduced length of stay, and eases the communication burden on the care team because the right people are notified and engaged together”, said Aidoc CEO Elad Walach.

3. Silverlon Receives FDA 510k Clearance for Radiation Dermatitis and Cutaneous Radiation Injury

Argentum Medical, a medical device leader and pioneer of silver-plated dressing technology, announced that it received 510(k) clearance from the FDA for Radiation Dermatitis and Cutaneous Radiation Injury through dry desquamation for its Silverlon® Burn and Wound Care products.

Silverlon is the first medical device to be cleared in the U.S. for management of Cutaneous Radiation Injury through dry desquamation.

“This historic achievement is the culmination of more than 20 years of effort, thousands of hours of work and significant investment by our government. We are proud to provide an FDA-cleared product for the management of these injuries and further assist with disaster preparedness for our country,” states Raul Brizuela, CEO of Argentum Medical.

4. Apple Watch Parkinson’s Disease Tracking App Cleared by the FDA

The FDA has given h2o therapeutics 510(k) marketing clearance for its Parky app that monitors motor symptoms in Parkinson’s patients via measurements recorded by an Apple Watch.

Currently compatible only with Apple’s iOS operating system, the Parky app uses an Apple tool called Motion Disorder API to measure and record, among others, two hallmark motor symptoms of Parkinson’s: tremors and dyskinesia, or uncontrolled movements.

“As a woman-founded, non [venture capital]-backed company based in Turkey, receiving our first 510(k) clearance is a huge milestone for us,” Yagmur Selin Gulmus, h2o’s founder, said in a company press release. “We believe Parky will bring great value to the Parkinson’s Disease community as an easily scalable and data-driven product,” Gulmus added.