When you are developing an AI-enabled medical device, one thing is clear: getting your 510(k) submission right is crucial. It can be a daunting task, but with the right approach, you can streamline the process and increase your chances of success.
Kevin Bly, CEO of New Age Medical, a rapidly growing medical device company, talks about strategies and innovations that have fueled the company's impressive growth.
Orthopedic surgeon Dr. Matt Barber discusses the future of patient-specific surgeries with Enhatch.
HASBROUCK HEIGHTS, N.J., Oct. 30, 2024 /PRNewswire/ -- Enhatch Inc., a leader in AI-powered orthopedic preoperative planning solutions, is proud to announce the successful completion of its SOC 2® Type II and HIPAA/HITECH audit.
In the world of orthopedic oncology, patient-specific solutions are changing the game. Personalized approaches help surgeons navigate complex surgeries and improve patient outcomes. However, one major roadblock in scaling patient-specific solutions is the long lead times to deliver personalized solutions for surgery.
Enhatch recently participated in the insightful webinar organized by Synopsys Simpleware "AI-powered Efficiency: Enhatch and Synopsys for Patient-Specific Image-Based Surgical Planning".
As the QA/RA Manager at Enhatch, I take immense pride in our organization's commitment to product excellence and patient safety. Enhatch is focused on helping medical device companies, hospitals, and distributors easily plan, manage, and scale patient-specific solutions.
Kitting is an operational function that is crucial to orthopedic device manufacturers. It involves assembling and packaging various components, instruments, and implants needed for specific medical procedures into a single kit.
Orthopedic oncology is a field dedicated to treating bone and soft tissue tumors, a niche yet crucial aspect of oncology. Traditionally, this market has been an underserved market, but in recent years, it has gained increasing attention.
The landscape of orthopedic surgery is changing rapidly, propelled by the rapid growth of robot-assisted procedures. The following industry facts are clear indicators of this seemingly irreversible growth trend: