Boston MedTech Advisors

In the rapidly evolving field of medical technology, understanding and meeting performance requirements for implant devices is crucial for ensuring safety and effectiveness. Our blog sheds light on the key performance standards that are reshaping the landscape for implantable devices. What you’ll discover: ✅ The latest regulatory expectations and standards ✅ Critical performance metrics for different types of implants ✅ Best practices for ensuring compliance and enhancing device reliability Whether you’re involved in device development, regulatory affairs, or quality assurance, staying informed about these requirements is essential for navigating the complexities of the medical device industry. Read the full blog for expert insights! Stay ahead of the curve and ensure your implant devices meet the highest standards of performance and safety. #BMTA #FDA  #HealthcareInnovation #RegulatoryCompliance #MedTech #MedicalDevices #Implants

Navigating the New Landscape of Laboratory Developed Tests (LDTs): 🧪 The House Appropriations Committee requested to suspend implementation of this final rule on July 10, 2024. What happens next? Stay tuned - BMTA will keep you updated! In April the FDA released its final rule on Laboratory Developed Tests (LDTs), bringing significant changes to the regulatory environment. Our blog post “FDAs Final Rule on Laboratory Developed Tests (LDTs)” explores this regulatory update’s key provisions and expands on our previous post about the proposed rule. How long do laboratory developed tests have to begin to comply with the ins and outs of classifying in vitro diagnostic products (IVDs) as medical devices? Find out by reading the full blog here! #BMTA #FDA #LabTests #MedicalDiagnostics #HealthcareInnovation #RegulatoryUpdates #MedTech #LDTs #DiagnosticTesting

Excited to share our latest BMTA blog post! Discover how the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) Clinical Evidence Review impacts the journey of new medical devices. Dive into an insightful summary of the MEDCAC review process by checking out the blog here: #BMTA #Medicare #MEDCAC #ClinicalEvidence #Reimbursement #MedicalDevices

How is a medical device assigned a billing code, and does this guarantee coverage by payers? When should a company start planning its reimbursement strategy for a new medical device? Get these answers and more from our latest Q&A blog on medical device reimbursement from our expert team at BMTA! 💡 Learn how to navigate coding and coverage complexities in the ever-evolving healthcare landscape by reading more here: #BMTA #HealthcareCoding #MedicalDevices #MedicalDeviceReimbursement #ReimbursementUpdates #MedicalCoverage

FDA Issued Final Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations 💡 Dive into FDA’s Final Guidance on Digital Health Technologies (DHTs) for Remote Data Acquisition in Clinical Investigations through BMTA’s blog! The scope of the guidance has expanded since the 2021 draft to include software applications and wearables. Discover key insights such as: ✅ Which DHTs meet the definition of a medical device and are subject to design control requirements ✅ Considerations for ensuring DHTs used in clinical investigations are ‘fit-for-purpose’ ✅ A high-level summary of sections that were changed from the 2021 draft guidance Don’t miss out on this essential read for digital health entrepreneurs and manufacturers looking to use DHTs to remotely acquire clinical data! #BMTA #FDA #DigitalHealth #ClinicalInvestigations #HealthcareInnovation #RegulatoryGuidance

How is a medical device assigned a billing code, and does this guarantee coverage by payers? When should a company start planning its reimbursement strategy for a new medical device? Get these answers and more from our latest Q&A blog on medical device reimbursement from our expert team at BMTA! 💡 Learn how to navigate coding and coverage complexities in the ever-evolving healthcare landscape by reading more here: #BMTA #HealthcareCoding #MedicalDevices #MedicalDeviceReimbursement #ReimbursementUpdates #MedicalCoverage

When is real-world evidence useful to support medical device premarket submissions? 💡 BMTA’s blog post explores when real-world data may be of sufficient quality, according to FDA’s 2023 draft guidance. We outline the proposed update’s additions, which expand on the previous 2017 guidance, and are intended to help aid sponsors in determining when and how real-world data can be used. Let BMTA help you navigate these regulatory updates by keeping up with our blog, and by checking out our wide range of services offered to medical device startups and manufacturers! #MedicalDevices #RealWorldEvidence #PremarketSubmission #HealthcareInnovation #RegulatoryCompliance

Exciting news! FDA has issued a Draft Guidance on the Use of Clinical Data in Premarket Notification (510k) Submissions, and BMTA has all the essential details in our latest blog post. Explore FDA’s recommendations on how to assess when clinical data may be needed in a 510(k) to demonstrate that a new device is substantially equivalent (SE) to a predicate device. Outlined for your benefit are the most common scenarios in which clinical data may be required, and we have even included a summary of some initial comments collected on the draft so far. Stay ahead in the dynamic world of medical device regulations by checking out our post here! #BMTA #FDA #MedicalDevices #RegulatoryCompliance #510k #ClinicalData #HealthcareInnovation

Changes ahead in healthcare coding! Our latest blog post explores the transition towards ICD-11, covering essential topics such as: ✅ Benefits of transitioning to ICD-11. ✅ Considerations when implementing the new system in the U.S. ✅ Impact on medical device and life science companies.   Check out the full blog post here! #BMTA #ICD11 #HealthcareCoding #MedicalClassification #HealthTech

FDA's view on biocompatibility testing for medical devices...