A roadmap for medical device innovators is presented that highlights the essential steps for regulatory authorization, market access, and reimbursement strategies in the USA, with a focus on strategic planning for commercial success, underscoring the integration of regulatory and market access considerations from the initial development of a medical device.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.tibtech.2024.07.016 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Cost-Utility Analysis of LifeVest® in Post-Myocardial Infarction Patients at Risk of Sudden Cardiac Death in England.
Pharmacoecon Open
January 2025
Optimax Access Ltd, Kenneth Dibben House, Enterprise Rd, Chilworth, Southampton University Science Park, Southampton, UK.
Background: Patients with a left ventricular ejection fraction ≤ 35% are at increased risk of sudden cardiac death (SCD) within the first months after a myocardial infarction (MI). The wearable cardioverter defibrillator (WCD) is an established, safe and effective solution which can protect patients from SCD during the first months after an MI, when the risk of SCD is at its peak. This study aimed to evaluate the cost-effectiveness of WCD combined with guideline-directed medical therapy (GDMT) compared to GDMT alone, after MI in the English National Health Service (NHS).
View Article and Find Full Text PDFPostoperative pain in primary root canal treatments after Er: YAG laser-activated irrigation: a systematic review and meta-analysis.
Lasers Med Sci
January 2025
Universidade Federal de Pelotas, Pelotas, Brazil.
This systematic review aimed to compare postoperative pain in endodontic treatments using PIPS Er: YAG laser-activated irrigation (LAI) versus conventional needle irrigation. An electronic search was conducted to identify randomized clinical trials (RCT) investigating postoperative pain in patients who underwent root canal treatments in permanent teeth using PIPS Er: YAG laser-activated irrigation or conventional needle irrigation. Two reviewers performed study selection, data extraction, risk of bias assessment (RoB 2.
View Article and Find Full Text PDFEvaluating the risk of extrusion with laser-activated irrigation techniques in root canal systems: a cadaver-based study.
Clin Oral Investig
January 2025
Department of Endodontics, Texas A&M College of Dentistry, Dallas, Texas, USA.
Objectives: The objective of this study is to evaluate the incidence and volume of contrast medium extrusion when activated with a laser and to compare these outcomes with those of other irrigation techniques.
Materials And Methods: Sixteen cadaver mandibles containing 116 single-rooted teeth were prepared using conventional rotary instrumentation. The teeth were randomly assigned to four irrigation groups: side-vented needle, sonic irrigation, laser activation at the orifice, and laser activation at the middle third of the canal.
ML-based tooth shade assessment to prevent metamerism in different clinic lights.
Lasers Med Sci
January 2025
Erzincan University, 24002, Erzincan, Turkey.
The aesthetic understanding has found its place in dental clinics and prosthetic dental treatment. Determining the appropriate prosthetic tooth color between the clinician, patient and technician is a difficult process due to metamerism. Metamerism, known as the different perception of the color of an object under different light sources, is caused by the lighting differences between the laboratory and the dental clinic.
View Article and Find Full Text PDFTreatment strategies for soft tissue injuries associated with blunt brachial artery injury.
Eur J Orthop Surg Traumatol
January 2025
Shonan Kamakura General Hospital, Kamakura, Japan.
Introduction: Blunt brachial artery injuries (BAI) require reconstruction with an extensive vein graft due to the wide area of arterial damage. In the upper arm, safe options for pedicle flaps are limited, and selecting recipient vessels for free-flap surgery is challenging, complicating the treatment of soft tissue injuries associated with blunt BAI. This study aimed to analyze the characteristics and soft tissue reconstruction of blunt BAI and propose treatment strategies for treating associated soft tissue injuries.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!