Barbed Sutures for Total Hip and Knee Arthroplasty Have Shorter Wound Closure Time and are Cost-Effective in Comparison to Traditional Sutures: A Systematic Review and Meta-analysis of 16 Randomized Controlled Trials | Indian Journal of Orthopaedics | |
Biosensor-Based Point-of-Care Devices: Metabolites and Pulse Oximetry | | 2022 |
Breast density distribution among the Saudi screening population and correlation between radiologist visual assessment and two automated methods | | 2022 |
Steps in Device and Drug Pathway Development: Clinical Trials, Similarities, and Differences | Success in Academic Surgery | 2020 |
Endoscopic Clips and Glues | | 2020 |
Chagas disease serological test performance in United States blood donor specimens | | |
Clinical Trials for IOP-Lowering Devices to Support an FDA Premarket Submission | | 2014 |
Databases and Data Management for Robotic Surgery | | 2011 |
Regulatory and Reimbursement Aspects of Radiosurgery | | 2008 |
A Comparison Between Transcutaneous Bilirubin and Total Serum Bilirubin Levels for the Management of Jaundice in Preterm Neonates by Bland-Altman Plot | Cureus | 2021 |
Mapping the genealogy of medical device predicates in the United States | PLoS ONE | 2021 |
Continuous Ketone Monitoring Consensus Report 2021 | Journal of Diabetes Science and Technology | 2021 |
Cost effectiveness analysis comparing repetitive transcranial magnetic stimulation to antidepressant medications after a first treatment failure for major depressive disorder in newly diagnosed patients - A lifetime analysis | PLoS ONE | 2017 |
Placing a price on medical device innovation: the example of total knee arthroplasty | PLoS ONE | 2013 |
Clinical Evidence Supporting FDA Clearance of First-of-a-Kind Therapeutic Devices via the De Novo Pathway Between 2011 and 2019 | | |
Antimicrobial and Anti-Biofilm Medical Devices: Public Health and Regulatory Science Challenges | | 2017 |
Rapid Methods for Detection of MRSA in Clinical Specimens | Methods in Molecular Biology | 2020 |
How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals | Nature Medicine | 2021 |
The Treatment of Non-Melanoma Skin Cancer with Image-Guided Superficial Radiation Therapy: An Analysis of 2917 Invasive and In Situ Keratinocytic Carcinoma Lesions | Oncology and Therapy | 2021 |
Photobiomodulation for the management of hair loss | Photodermatology Photoimmunology and Photomedicine | 2021 |
Intraoperative Localization Using an Implanted Radar Reflector Facilitates Resection of Non-Palpable Trunk and Extremity Sarcoma | Annals of Surgical Oncology | 2021 |
The regulatory process from concept to market | | 2020 |
Toward standardized premarket evaluation of computer aided diagnosis/detection products: insights from FDA-approved products | Expert Review of Medical Devices | 2020 |
An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19 | Clinical and Translational Science | 2020 |
Introduction to biomedical manufacturing | | 2020 |
Dosing inaccuracy with enteral use of ENFit ® low-dose tip syringes: The risk beyond oral adapters | Journal of Clinical Pharmacy and Therapeutics | 2020 |
Intellijoint HIP: A 3D Minioptical, Patient-Mounted, Sterile Field Localization System for Orthopedic Procedures | | 2020 |
Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine | JAMA - Journal of the American Medical Association | 2019 |
Levels of clinical condom failure for anal sex: A randomized cross-over trial | EClinicalMedicine | 2019 |
Cybersecurity features of digital medical devices: an analysis of FDA product summaries | BMJ Open | 2019 |
Chagas Disease Serological Test Performance in U.S. Blood Donor Specimens | Journal of Clinical Microbiology | 2019 |
Aluminosilicate-based composites functionalized with cationic materials: possibilities for drug-delivery applications | | 2019 |
On the thermal processing and mechanical properties of 3D-printed polyether ether ketone | MRS Communications | 2019 |
Innovation process of mHealth: An overview of FDA-approved mobile medical applications | International Journal of Medical Informatics | 2018 |
Electrospun Antimicrobial Wound Dressings: Novel Strategies to Fight Against Wound Infections | Recent Clinical Techniques, Results, and Research in Wounds | 2018 |
Photobiomodulation and Hair Growth | | 2018 |
The Evolution of Oral Appliance Therapy for Snoring and Sleep Apnea: Where Did We Come From, Where Are We, and Where Are We Going? | Sleep Medicine Clinics | 2018 |
Laboratory Diagnosis of Respiratory Tract Infections in Children - the State of the Art | Frontiers in Microbiology | 2018 |
Understanding outcomes and toxicological aspects of second generation metal-on-metal hip implants: a state-of-the-art review | Critical Reviews in Toxicology | 2018 |
Harmonizing Standards and Incentives in Medical Device Regulation: Lessons Learned from the Parallel Review Pathway | Journal of Law, Medicine and Ethics | 2018 |
Public Regulatory Databases as a Source of Insight for Neuromodulation Devices Stimulation Parameters | Neuromodulation | 2018 |
Innovation Incentives and Biomarkers | Clinical Pharmacology and Therapeutics | 2018 |
Adjunctive Diagnostic Techniques for Oral and Oropharyngeal Cancer Discovery | Dental Clinics of North America | 2018 |
Pharmacogenomic biomarkers: Interpretation of information included in United States and Japanese drug labels | Journal of Clinical Pharmacy and Therapeutics | 2018 |
Wireless MEMS-based implantable medical devices for cardiology | | 2017 |
Guidelines for the Performance Evaluation of In-Vitro Diagnostic Test for the Detection of Norovirus Infection in Korea | Laboratory Medicine Online | 2017 |
Integrating Genomics into Drug Discovery and Development: Challenges and Aspirations | Pharmaceutical Medicine | 2017 |
The Atlantic divide in coronary heart disease: Epidemiology and patient care in the US and Portugal | Revista Portuguesa De Cardiologia (English Edition) | 2017 |
The Atlantic divide in coronary heart disease: Epidemiology and patient care in the US and Portugal | Revista Portuguesa De Cardiologia | 2017 |
The Role of the FDA and Regulatory Approval of New Devices for Diabetes Care | Current Diabetes Reports | 2017 |
Using the features of the time and volumetric capnogram for classification and prediction | Journal of Clinical Monitoring and Computing | 2017 |
US Food and Drug Administration Perspectives on Clinical Mass Spectrometry | Clinical Chemistry | 2016 |
Translational research of one dynamic hip screw system-from the SCI to the FDA | Journal of Orthopaedic Translation | 2016 |
¿Mejora la seguridad con un nuevo método de inserción de PICC? | Nursing (Ed Española) | 2015 |
Automated Competitive Protein-Binding Assay for Total 25-OH Vitamin D, Multicenter Evaluation and Practical Performance | Journal of Clinical Laboratory Analysis | 2015 |
The Assessment of the Readiness of Molecular Biomarker-Based Mobile Health Technologies for Healthcare Applications | Scientific Reports | 2015 |
Pathology consultation on HbA(1c) methods and interferences | American Journal of Clinical Pathology | 2014 |
Special commentary: Food and Drug Administration and American Glaucoma Society co-sponsored workshop: the validity, reliability, and usability of glaucoma imaging devices | Ophthalmology | 2014 |
Considerations for recommending extended use and limited reuse of filtering facepiece respirators in health care settings | Journal of Occupational and Environmental Hygiene | 2014 |
Hype or hope for diabetes mobile health applications? | Diabetes Research and Clinical Practice | 2014 |
Radiology smartphone applications; current provision and cautions | Insights Into Imaging | 2013 |
New technologies and trends in sterilization and disinfection | American Journal of Infection Control | 2013 |
Bilateral patellar component shear failure of highly cross-linked polyethylene components: report of a case and laboratory analysis of failure mechanisms | Journal of Arthroplasty | 2012 |
Cold-Drawn Bioabsorbable Ferrous and Ferrous Composite Wires: An Evaluation of Mechanical Strength and Fatigue Durability | Metallurgical and Materials Transactions B: Process Metallurgy and Materials Processing Science | 2012 |
Oral Appliances in Snoring and Sleep Apnea Syndrome | | 2012 |
Neurothrombectomy for the treatment of acute ischemic stroke in 1530 patients | Journal of Clinical Neuroscience | 2012 |
Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience | Journal of Medical Devices, Transactions of the ASME | 2012 |
FDA Regulation of Clinical Microbiology Diagnostic Devices | Journal of Clinical Microbiology | 2011 |
Systematic review: comparative effectiveness of adjunctive devices in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention of native vessels | BMC Cardiovascular Disorders | 2011 |
Left to their own devices: breakdowns in United States medical device premarket review | PLoS Medicine | 2010 |
Method of water nebulization used to prevent heat loss during laparoscopic surgery matters | Surgical Endoscopy and Other Interventional Techniques | 2009 |
EUS-guided submucosal implantation of a radiopaque marker: a simple and effective procedure to facilitate subsequent surgical and radiation therapy | Gastrointestinal Endoscopy | 2008 |
EUS-guided implantation of radiopaque marker into mediastinal and celiac lymph nodes is safe and effective | Gastrointestinal Endoscopy | 2007 |
Arthroscopic Fixation Devices | | 2006 |
Computed tomographic colonography: assessment of radiologist performance with and without computer-aided detection | Gastroenterology | 2006 |