1. Medtech Insight
  2. >>Archive

Ortho Companies Emphasize Software For Patient-Matched Instrumentation Guidance

Orthopedic device companies say FDA should provide guidance on how software used to design and implant patient-matched instrumentation could be regulated. They note that while physician experience and training is the key factor for surgeries using such devices, software is critical to how patient data is collected, evaluated and shared among surgeons and pre-operative personnel.

Companies say FDA should focus on software requirements for patient-matched instruments for orthopedic surgeries as the agency works to develop a draft guidance for the product category.

FDA's device center asked industry about how patient matched devices are designed and implanted in orthopedic surgeries earlier this year...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

Harbinger Health Showcases Two-Tiered MCED Test With Strong Specificity And Per-Cancer Accuracy

 
• By Shubham Singh

With a test platform designed to mirror the biological diversity of cancer, Harbinger Health is moving beyond traditional performance measures to introduce cancer-specific sensitivity and “intrinsic accuracy” as cornerstones of its clinical narrative.

Veterinary Heart Health Goes High-Tech: Eko And Boehringer Use AI To Spot Heart Murmurs In Dogs

 
• By Marion Webb

Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.

Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist

 
• By Natasha Barrow

Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.