Kblaster
kBLASTER is a SaaS platform that provides comprehensive search and result management tools for FDA 510(k) clearance summaries. It helps regulatory professionals and device developers find predicates, manage search results, and develop successful 510(k) strategies efficiently. The platform offers features like result sorting, favorites, saved searches, and automatic updates with new clearance data, accessible on any device.
Industries
Nr. of Employees
small (1-50)
Kblaster
Products
SaaS regulatory search and result-management platform
Web-based platform that indexes and searches the full text of publicly available premarket notification summaries and associated pages, providing advanced query capabilities, result management, automated alerts, data visualization, and links to original regulatory documents and related news.
SaaS regulatory search and result-management platform
Web-based platform that indexes and searches the full text of publicly available premarket notification summaries and associated pages, providing advanced query capabilities, result management, automated alerts, data visualization, and links to original regulatory documents and related news.
Services
Monthly subscription access to a browser-based search platform that indexes public regulatory premarket notification summaries and provides advanced search, result management, alerting, and source-linking features.
Custom consulting to assist with predicate selection and development of a premarket notification strategy and interpretation of search results.
Help resources, troubleshooting, and tutorials to improve use of the search platform and its advanced query capabilities.
Monthly subscription access to a browser-based search platform that indexes public regulatory premarket notification summaries and provides advanced search, result management, alerting, and source-linking features.
Custom consulting to assist with predicate selection and development of a premarket notification strategy and interpretation of search results.
Help resources, troubleshooting, and tutorials to improve use of the search platform and its advanced query capabilities.
Expertise Areas
- 510(k) predicate analysis and selection
- Regulatory strategy for premarket notifications
- Full-text regulatory document search and indexing
- Regulatory text analytics using NLP and machine learning
Key Technologies
- Full-text document indexing and search
- Natural language processing (NLP)
- Machine learning for text analytics
- Browser-based SaaS/web applications
News & Updates
Covalon Technologies Ltd. announced FDA 510(k) clearance for its SilverCoat™ Silicone Foley Catheter, designed for bladder drainage and reducing infection risk.
Meridian Bioscience received FDA 510(k) clearance for its illumigene® Pertussis molecular test system.
Visunex Medical Systems received FDA 510(k) clearance for its Panocam LT wide-field imaging system for newborns.
Deerfield Imaging received FDA clearance for its SYMBIS stereotactic brain biopsy system, enabling procedures inside MRI scanners.
Si-Bone's iFuse implant system received FDA 510(k) clearance for sacroiliac joint fusion treatments.
AtriCure announced FDA 510(k) clearance for its cryoFORM™ cryoablation probe.
Covalon Technologies Ltd. announced FDA 510(k) clearance for its SilverCoat™ Silicone Foley Catheter, designed for bladder drainage and reducing infection risk.
Meridian Bioscience received FDA 510(k) clearance for its illumigene® Pertussis molecular test system.
Visunex Medical Systems received FDA 510(k) clearance for its Panocam LT wide-field imaging system for newborns.
Deerfield Imaging received FDA clearance for its SYMBIS stereotactic brain biopsy system, enabling procedures inside MRI scanners.
Si-Bone's iFuse implant system received FDA 510(k) clearance for sacroiliac joint fusion treatments.
AtriCure announced FDA 510(k) clearance for its cryoFORM™ cryoablation probe.