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The HeroTracker Sense Device (HTS) is an add-on device which is attached by patients on a metered-dose inhaler (MDI). HTS is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inhaler shake, inhaler orientation, inhalation coordination, and inspiratory strength and duration for prescribed inhaler usage. HTS may be used in the following applications: in clinical practice or clinical trials, where specialists, general practitioners, nurses and educators need to know if a patient has used their prescribed medication or assess inhaler technique. HTS is designed to work only with the MDI and medication indicated on the HTS label. HTS is not intended to indicate the remaining quantity of medication in an inhaler and does not include a dose counting function. HTS is not intended to provide spirometry measurements. HTS is intended to be used by Metered Dose Inhaler (MDI) users aged 12 years and over.

The HeroTracker Sense (HTS) is a nebulizer accessory. It is an add-on device which is attached by patients on a metered dose inhaler (MDI) and is used to record and analyze data related to medication actuation and technique of use for prescribed inhaler usage. Data is transferred to a mobile application with appropriate settings and is displayed to end users.

The Insulia Bolus Companion is indicated for the management of diabetes by adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software. This can be done through a dedicated, secured web portal.

Insulia Bolus Companion is a prescription device indicated for the management of diabetes, for adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data; and for healthcare professionals (HCP) having experience in the management of people with diabetes treated with bolus insulin. Insulia Bolus Companion is for prescription use and is not for over-the-counter sale. Insulia Bolus Companion includes a Bolus Calculator intended to provide direction to the patient in response to blood glucose (BG) and health events, within the scope of a preplanned treatment program prescribed by their HCP for insulin suggestions. The guidance is similar to the directions provided to patients as a part of routine clinical practice: prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software. An HCP can only start using Insulia Bolus Companion after having been registered by the Manufacturer or the delegate field-support team. Insulia Bolus Companion includes three components: - · A mobile application for use by people with diabetes on commercially available smartphones (iPhone or Android) and tablets, enabling patients to document BG measurements, meals, and generate dose suggestions for bolus insulin - · A web-based application for use by HCPs in professional healthcare settings through a compatible web browser on a computer, allowing patient inclusion and patient monitoring in-person and by distance - · A secure database hosted in a private cloud environment and used to securely store patient data

Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog. Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetesrelated healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, and evaluation of patient data in order to support effective diabetes management. Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice. Insulia Diabetes Management Companion intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols. Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Insulia Diabetes Management Companion is a mobile and web-based diabetes management system for adult type 2 diabetes patients and their healthcare team. Insulia Diabetes Management Companion includes three components: - A mobile medical application for use by patients on commercially available smartphones (iPhones and Android phones) and tablets. - A web-based application for use by patients in their home on their personal computer and on their mobile device, or by HCPs in professional healthcare settings through a compatible web browser on a personal computer. - A secure database hosted in a private cloud environment and used to securely store patient data. Insulia Diabetes Management Companion provides secure capture, storage and transmission of blood glucose data and other diabetes-related healthcare information to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management. Insulia Diabetes Management Companion includes a Basal Calculator intended to provide directions to the patient in response to blood glucose measurements and other diabetesrelated events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments. The guidance is similar to the directions provided to patients as a part of routine clinical practice. Insulia Diabetes Management Companion provides educational coaching messages based on blood glucose values. Insulia Diabetes Management Companion is only indicated for use with insulin detemir (Levemir® U-100) once or twice daily, insulin degludec (Tresiba® U-100) once daily, and insulin glargine (Basaglar® U-100, Lantus® U-100, Semglee® U-100, Toujeo® U-300) once daily. Insulia should not be used for: - basal dose recommendations for intermediate-acting insulin (NPH - Neutral Protamine Hagedorn); - premixed insulin Insulia should not be used in the following populations: - pregnant women; - non-adult patients; - patients that are treated with a basal-plus or a basal-bolus regimen (i.e multiple mealtime insulin injections per day or insulin pump therapy)

Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog. Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes related healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, and evaluation of patient data in order to support effective diabetes management. Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice. Insulia Diabetes Management Companion intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols. Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Insulia Diabetes Management Companion is a mobile and web based diabetes management system for adult type 2 diabetes patients and their healthcare team. Insulia Diabetes Management Companion includes three components: - . A mobile medical application for use by patients on commercially available smartphones (iPhones and Android phones) and tablets. - . A web-based application for use by patients in their home on their personal computer and on their mobile device, or by HCPs in professional healthcare settings through a compatible web browser on a personal computer. - . A secure database hosted in a private cloud environment and used to securely store patient data. Insulia Diabetes Management Companion provides secure capture, storage and transmission of blood glucose data and other diabetes-related healthcare information to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management. Insulia Diabetes Management Companion includes a Basal Calculator intended to provide directions to the patient in response to blood glucose measurements and other diabetesrelated events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments. The guidance is similar to the directions provided to patients as a part of routine clinical practice. Insulia Diabetes Management Companion provides educational coaching messages based on blood glucose values. Insulia Diabetes Management Companion is only indicated for use with insulin detemir (Levemir® U-100) once or twice daily, insulin degludec (Tresiba® U-100) once daily, and insulin glargine (Basaglar® U-100. Lantus® U-100. and Toujeo® U-300) once daily. Insulia Diabetes Management Companion should not be used for: - basal dose recommendations for intermediate-acting insulin (NPH Neutral Protamine Hagedorn); - " premixed insulin. Insulia Diabetes Management Companion should not be used in the following populations: - = pregnant women; - non-adult patients: - patients that are treated with a basal-plus or a basal-bolus regimen (i.e multiple mealtime insulin injections per day or insulin pump therapy).

Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog. Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes related healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, and evaluation of patient data in order to support effective diabetes management. Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice. Insulia Diabetes Management Companion intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols. Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Insulia Diabetes Management Companion is a mobile and web based diabetes management system for adult type 2 diabetes patients and their healthcare team. Insulia Diabetes Management Companion includes three components: - A mobile medical application for use by patients on commercially available smartphones (iPhones and Android phones) and tablets. - A web-based application for use by patients in their home on their personal computer and on their mobile device, or by HCPs in professional healthcare settings through a compatible web browser on a personal computer. - A secure database hosted in a private cloud environment and used to securely store patient data. Insulia Diabetes Management Companion provides secure capture, storage and transmission of blood glucose data and other diabetes-related healthcare information to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management. Insulia Diabetes Management Companion includes a Basal Calculator intended to provide directions to the patient in response to blood glucose measurements and other diabetes related events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments. The guidance is similar to the directions provided to patients as a part of routine clinical practice. Insulia Diabetes Management Companion provides educational coaching messages based on blood glucose values. Insulia Diabetes Management Companion is only indicated for use with insulin detemir (Levemir® U-100) once or twice daily, and insulin glargine (Lantus® U-100, and Toujeo® U-300) once daily. Insulia Diabetes Management Companion is not to be used by patients using NPH (Neutral Protamine Hagedorn) insulin and premixed insulin. Insulia Diabetes Management Companion is not to be used by patients treated with a basal plus or a basal-bolus regimen (i.e. including multiple mealtime regular or rapid-acting insulin injections per day or insulin pump therapy). Insulia Diabetes Management Companion is not to be used during pregnancy nor by non-adult patients.

Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog. Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes-related healthcare information, to enhance data management, to display reports and graphs, and to aid the patient in the review, and evaluation of patient data in order to support effective diabetes management. Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice. Insulia Diabetes Management Companion intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols. Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Insulia Diabetes Management Companion is a mobile and web based diabetes management system for type 2 adult diabetes patients and their healthcare team. Insulia Diabetes Management Companion includes three components: - I A mobile medical application for use by patients on commercially available smartphones (iPhones and Android phones) and tablets. - . A web-based application for use by patients in their home on their personal computer and on their mobile device, or by HCPs in professional healthcare settings through a compatible web browser on a personal computer. - A secure database hosted in a private cloud environment and used to securely store patient data. Insulia Diabetes Management Companion provides secure capture, storage and transmission of blood glucose data and other diabetes-related healthcare information to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review. analysis, and evaluation of patient data in order to support effective diabetes management. Insulia Diabetes Management Companion includes a Basal Calculator intended to provide directions to the patient in response to blood glucose measurements and other diabetesrelated events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments. The guidance is similar to the directions provided to patients as a part of routine clinical practice. Insulia Diabetes Management Companion provides educational coaching messages based on blood glucose values. Insulia Diabetes Management Companion is not to be used in conjunction with a type of long-acting insulin analog different from insulin glargine (Lantus®) or insulin detemir (Levemir®). Insulia Diabetes Management Companion is not to be used by patients using NPH (Neutral Protamine Hagedorn) insulin and premixed insulin. Insulia Diabetes Management Companion is not to be used by patients treated with a basalplus or a basal-bolus regimen (i.e. including multiple mealtime regular or rapid-acting insulin injections per day or insulin pump therapy). Insulia Diabetes Management Companion is not to be used during pregnancy nor by nonadult patients.