Predicate | Jotup

Pontimax Technologies' Inferencing Agent Delivers Inferencing & Reasoning Ability to UAVs Operating Over the Battle Space

Retrieved on:

火曜日, 10月 10, 2023

Knowledge, Weapon, ROE, TAK, Unmanned aerial vehicle, RCIC, Dynamics, UAV, C&C, Inference, Capability, Machine learning, Predicate, Atmosphere, Management

"Pontimax's Dynamic Inferencing Agent, with its innovative inferencing and reasoning capabilities, when positioned in Battlespace UAVs, is capable of delivering multi-command echelon situation awareness that can be combined with Rules of Engagement (ROE) based autonomous weapons deployment.

Key Points:

"Pontimax's Dynamic Inferencing Agent, with its innovative inferencing and reasoning capabilities, when positioned in Battlespace UAVs, is capable of delivering multi-command echelon situation awareness that can be combined with Rules of Engagement (ROE) based autonomous weapons deployment.
Moreover, predicate-based Inferencing & Reasoning provides the only currently available capability to directly embody ROE with real-time enforcement."
The Capability & Coverage Knowledge Base is the key to the Inferencing Agent's ability to apply its inferencing & reasoning capabilities to mission-relevant sensor data.
The Inferencing Deployment Harness uses the mission inferencing requirements contained in the Capabilities & Coverage Knowledge Base to marshal the necessary mission Inferencing Profiles Inferencing Predicates and download their constituent components to the C&C determined mission Inferencing Platforms.

Soliton Receives FDA Acceptance for 510(k) Application

Retrieved on:

水曜日, 7月 15, 2020

Health, Articles, Food law, Pharmaceuticals policy, Food and Drug Administration, United States Public Health Service, Federal Food, Drug, and Cosmetic Act, Predicate

Further, there were no unexpected or serious adverse events and the average pain scores were 2.4 on a 10-point scale.

Key Points:

Further, there were no unexpected or serious adverse events and the average pain scores were 2.4 on a 10-point scale.
Dr. Christopher Capelli, president and CEO of Soliton, said, "We are very pleased with the progress of our premarket notification through the FDA review process."
Dr. Capelli continued, "Having found that our submission contained all the necessary elements and information, we look forward to the substantive review and FDA clearance of the RAP device."
However, acceptance of our application does not indicate that the FDA has accepted the Company's predicate argument.

Accelerated Road to Market Approval for CERAMENT® G in the US - BONESUPPORTTM Submits De Novo Application

Retrieved on:

月曜日, 3月 23, 2020

Health, Food and Drug Administration, United States Public Health Service, Articles, Bonesupport, Predicate

During the winter, BONESUPPORThas been indialogue with the USFood and Drug Administration, the FDA, to investigate whether CERAMENT G could, through a De Novo application, obtain market approval for the indication osteomyelitis.

Key Points:

During the winter, BONESUPPORThas been indialogue with the USFood and Drug Administration, the FDA, to investigate whether CERAMENT G could, through a De Novo application, obtain market approval for the indication osteomyelitis.
A De Novo application can be made when there is no comparable established alternative ("predicate device") on the market.
The dialogue with the FDA has resulted inCERAMENT Gbeinggranted designation as a"Breakthrough Device"andthatBONESUPPORThas decidedto submit a De Novo application in April 2020.
It shows the potential of our antibiotic-releasing products as we now work for accelerated market approval in the United States.

Emerging Data Integrity Concepts and Audit Focus Areas - Two Day Event: Philadelphia, U.S. - May 11-12, 2020 - ResearchAndMarkets.com

Retrieved on:

火曜日, 2月 25, 2020

Professional services, Other Professional Services, Predicate

Module 1 - Setting the scene: importance of DI

Key Points:

Module 1 - Setting the scene: importance of DI
Mitigating the single most DI factor: Human behavior and their drivers
Raw Data management - why significant, applicable predicate rule, DI guidance
Laboratory Controls - what is it, its predicate rule and Table of Contents of its SOP
Module 4 - Recipe for DI success: a process-centric approach
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200225005461/en/

2-day Workshop: Current Regulatory Thinking on Data Integrity in 2020 | Philadelphia, USA - May 11-12, 2020

Retrieved on:

金曜日, 2月 21, 2020

Predicate

Module 1 - Setting the scene: importance of DI

Key Points:

Module 1 - Setting the scene: importance of DI
Mitigating the single most DI factor: Human behavior and their drivers
Raw Data management - why significant, applicable predicate rule, DI guidance
Laboratory Controls - what is it, its predicate rule and Table of Contents of its SOP
Module 4 - Recipe for DI success: a process-centric approach
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Why the FDA Commissioner Pushed to Shorten Medical Device Approval Process

Retrieved on:

火曜日, 3月 19, 2019

Health, Medical devices, Articles, Food and Drug Administration, United States Public Health Service, Predicate, Scott Gottlieb, Office of In Vitro Diagnostics and Radiological Health, Federal Food, Drug, and Cosmetic Act

It is estimated that presently bringing a device to market takes an average of 3 to 7 years.Last November, it appeared that the Commissioner of the FDA intended to drastically shorten the approval process.

Key Points:

It is estimated that presently bringing a device to market takes an average of 3 to 7 years.Last November, it appeared that the Commissioner of the FDA intended to drastically shorten the approval process.
In a recent article published on CNBC.com, Commissioner Scott Gottlieb said:"We plan to overhaul the 510(k) clearance process for medical devices and push the medical device market toward new technology.
The FDA is overhauling the most common way medical device manufacturers bring their products to market in an attempt to advance new technologies."
Nearly 20 percent of products cleared through the 510(k) pathway are based on a predicate device that's more than 10 years old, they said.

Why the FDA Commissioner Pushed to Shorten Medical Device Approval Process

Retrieved on:

火曜日, 3月 19, 2019

It is estimated that presently bringing a device to market takes an average of 3 to 7 years.Last November, it appeared that the Commissioner of the FDA intended to drastically shorten the approval process.

Key Points:

It is estimated that presently bringing a device to market takes an average of 3 to 7 years.Last November, it appeared that the Commissioner of the FDA intended to drastically shorten the approval process.
In a recent article published on CNBC.com, Commissioner Scott Gottlieb said:"We plan to overhaul the 510(k) clearance process for medical devices and push the medical device market toward new technology.
The FDA is overhauling the most common way medical device manufacturers bring their products to market in an attempt to advance new technologies."
Nearly 20 percent of products cleared through the 510(k) pathway are based on a predicate device that's more than 10 years old, they said.

Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway

Retrieved on:

火曜日, 11月 27, 2018

Logic, Health, Mathematical logic, Predicate logic, Food and Drug Administration, United States Public Health Service, Medical device, Predicate

Manufacturers often rely on comparative testing to predicate devices to demonstrate that a new device is substantially equivalent to the predicate.

Key Points:

Manufacturers often rely on comparative testing to predicate devices to demonstrate that a new device is substantially equivalent to the predicate.
A key part of our announcement is our intent to use our authorities to push for the use of more modern predicate devices.
When new devices rely on older predicates, they may not be accounting for, in their new submissions to the FDA, the latest advances in technology that could benefit patients.
We'll be taking additional steps to enhance the FDA's review of medical devices and ensure we maintain our global gold standards for safety and effectiveness.