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The Huma platform is a modular Software as a Medical Device (SaMD) which
may utilise compatible devices and software to obtain data collated via a
mobile app or web app and delivered to the clinician via a web portal or web
app where it may be viewed to drive clinical management. It is intended to be
used for the physiological and non-physiological intermittent or spot-check
monitoring of all condition patients in professional healthcare facilities, such
as clinics, hospitals or skilled nursing facilities, or in the patient’s home
setting. It is intended for the monitoring of patients by trained healthcare
professionals.
The Huma platform comprises a number of different modules and
functionalities that can be selected by the customer for configuration of care
plans which can be further personalised for the patients.
Clinical information collected from these modules is displayed on a clinician
web portal and patient app with the addition of flagging out of range
datasets, trend visualisation, goal setting and communication channels
between clinicians and patients.
MedoPad Inc.
1.34
In Commercial Distribution
- G2871002 ()
1002
- Self-care monitoring/reporting software
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump.
The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates
electronic reports intended for a healthcare provider.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202258OTC0 ()
- Self-care monitoring/reporting software
Lilly Health Personalized Health & Medicine Platform is intended for providing medication reminders, medication dose logging, and health data logging, depending
upon the medicinal product prescribed or condition.
WELLDOC, INC.
1.X
In Commercial Distribution
- B553202202OTC0 ()
- Medication reminder application software
Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution
- M727SAVEREVOH013 ()
PAD-ACC-03
- External defibrillator application software
Lilly Health Personalized Health & Medicine Platform is intended for providing medication reminders, medication dose logging, and health data logging, depending
upon the medicinal product prescribed or condition.
WELLDOC, INC.
1.X
In Commercial Distribution
- B553202201OTC0 ()
- Medication reminder application software
No Description
Neurovision Medical Products, Inc.
NONE
In Commercial Distribution
- B006EMGVIEW0 ()
- Bioelectrical signal analysis software
Athena GTX Device Management Suite - Android
ATHENA GTX, INC.
ADMS Android Software
In Commercial Distribution
- B3943950010000 ()
395-0010-00
- Centralized patient monitor
Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution
- B3943950009000 ()
395-0009-00
- Centralized patient monitor
Athena GTX Device Management Suite - PC
ATHENA GTX, INC.
ADMS PC Software
In Commercial Distribution
- B3943900008000 ()
390-0008-00
- Centralized patient monitor
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MEPHYSTO mc² software
In Commercial Distribution
- EPTWS0800450 ()
S080045
- Multi-modality therapeutic radiation phantom, anthropomorphic