Who We Are
This site is owned by Bracco Diagnostics Inc.
Thank you for visiting this online portal, website, or mobile application, which is owned and operated by Bracco Diagnostics Inc., and/or one of its parent corporations, subsidiaries or affiliates (collectively “BDI,” “We” or “Our“). BDI is committed to respecting your privacy, and this Privacy Policy is intended to answer your important questions about how BDI may process your Personal Data about you through your online and off-line interactions with BDI through BDI services, products, communications, and digital properties that refer to this Privacy Policy.
BDI, the U.S.-based subsidiary of Bracco Imaging SpA, and part of the Bracco Group, is a leader in innovative contrast imaging agents in the U.S. BDI, established in 1994, with headquarters and research offices in Monroe Township, NJ, offers a product and solution portfolio for all key diagnostic imaging modalities: X-Ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers. The diagnostic imaging offer is completed by several medical devices and advanced administration systems for contrast imaging products in the fields of radiology.
This Privacy Policy applies regardless of whether you access or use this site via a computer, mobile device or other platform. This Privacy Policy also applies to personal information we obtain through email communications, our online channels (including other websites, online product catalogs, mobile applications and social media websites that reference this Privacy Policy) and to personal information you provide us offline, e.g. at trade shows or sales exhibitions, when you place an order over the phone or when you contact our customer service (all such online channels, websites, online product catalogs, mobile applications and social media sites shall collectively be referred to herein as the “Services”).
Please carefully read this Privacy Policy to learn more about how we collect, use, disclose and store information provided and the steps we take to help protect the often-sensitive information provided from unauthorized use or disclosure. When you submit information to or through the Services, you consent to the collection, processing and retention of your information as described in this Privacy Policy.
This Privacy Policy is incorporated into and made a part of our Terms of Service. If you have not done so already, please also review BDI’s Terms of Service. The Terms of Service contain provisions that limit BDI’s liability to users of the Services.
IF YOU DO NOT AGREE WITH ANY PART OF THIS PRIVACY POLICY, THEN PLEASE DO NOT USE ANY OF THE SERVICES.
Please note that this Privacy Policy does not apply to information collected through third-party websites or services that you may access through the Services.
I. INFORMATION WE COLLECT
When you use the Services, we collect the following:
II. HOW INFORMATION IS COLLECTED AND USED
BDI collects and uses information to operate the Services, including:
Information That You Voluntarily Provide When Using the Services.We collect and use the Personal Information that you voluntarily provide to us through the Services. You may use certain Services without registering or identifying yourself but, if you do not register, you may not have access to all of the Services. If you choose to register, we may use the Personal Information you provide to confirm your registration and to respond to requests from you. Upon your request, we may also use the Personal Information to send you special promotions, newsletters or other information that may interest you.
If you are a healthcare professional or an institutional healthcare provider (collectively, “Providers“), you are responsible for obtaining any legally required authorization, consent or other permission from your patients prior to providing their Personal Information to BDI through the Services. By submitting any Personal Information about a patient, you represent and warrant to BDI that you have obtained all required permissions to do so.
Through Your Use of Interactive Services. If you choose to participate in our questionnaires and surveys and other interactive Services, we will collect the information that you share to help us better understand how BDI products are used in diagnosing and treating diseases for which they are marketed.
The information you provide through interactive Services may be combined (subject to all applicable laws) with the Personal Information provided elsewhere in or through the Services. We may combine your and others’ Personal Information to create summary data that we will use for our business purposes, such as research to improve our products and analyses that may help us better market our products.
You may provide information to be published or displayed (“Posted“) on public areas of the Services (collectively, “User Contributions“). Your User Contributions are Posted and made available publicly at your own risk. BDI does not control the actions of third parties with access to your User Contributions.
When you Correspond with BDI about BDI Products. If you contact BDI or use the Services to ask questions or report problems regarding your experience in using one of our products, we may use the information you provide in submitting reports to the U.S. Food and Drug Administration and as otherwise required of us by law. We also may use the information to contact the prescribing physician to follow up regarding an event involving use of our product.
Through Data Collection Tools. BDI also automatically collects information about use of the Services through data collection tools, such as web beacons and cookies.
A “web beacon” is a piece of code that enables us to monitor user activity and website traffic. A “cookie” is a randomly-generated unique numeric code stored in the user’s web browser settings or computer’s hard drive. A cookie typically contains the name of the domain (internet location) from which the cookie originated, the “lifetime” of the cookie (i.e., when it expires), as well as the randomly generated unique numeric code.
We use the information collected through data collection tools to monitor usage patterns, store information about user preferences and to improve the Services. For example, your Personal Information may be used to create customized offers, information and services tailored to your interests and preferences. We may track your activities over time and across third-party websites, apps or other online services to display advertisements on third-party websites. If you do not want us to use your information in this way, please see “Your Privacy Choices” below. For more information about our digital advertising practices, please see “Digital Advertising” below.
When you Connect with Social Media though the Services: Certain Services may link with social media platforms and social media plug-ins (e.g., the Facebook “Like” button, “Share to Twitter” button) (collectively, “Social Media”). When accessing the Services through a Facebook or other Social Media account, BDI may (depending on the applicable user privacy settings) automatically have access to information provided to or through the Social Media platform. BDI may collect and use this information for the purposes described in this Privacy Policy or at the time the information was collected.
Through Service Providers or Publicly Available Sources: We may receive information about you from other sources, including publicly available databases or third parties from whom we have purchased data, and combine this data with information we already have about you. This helps us to update, expand and analyze our records, identify new customers, and provide products and services that may be of interest to you. If you provide us Personal Information about others, or if others give us your information, we will only use that information for specific reasons for which it was provided to us.
Examples of the types of personal information that may be obtained from public sources or purchased from third parties and combined with information we already have about you, may include:
In addition. third parties that assist us with our business operations also collect and use information (including Personal Information and Usage Data) through the Services and also may share the collected information with us. For example, our vendors collect and share information with us to analyze use of the Services, to help us detect and prevent fraud and to improve user experience.
III. HOW INFORMATION IS SHARED AND DISCLOSED
We may share and disclose information as described at the time information is collected and as follows:
To Perform Services. We may use third parties to perform services requested or functions initiated by users. In addition, we may disclose Personal Information to identify a user in connection with communications sent through the Services. We also may offer users the opportunity to share information with friends and other users through the Services.
With BDI’s Third Party Contractors. We share information, including Personal Information, with our service providers to perform the functions for which we engage them, such as data analysis, system design and maintenance, customer services and for marketing and promotions.
With Co-branding Partners. We may partner with other companies to provide you with content or services on a joint or “co-branded” basis. When websites or services are co-branded, you will see both the BDI logo and the logo of our co-branding partner. When you register for a co-branded website or service, your registration information may be shared with one or more of BDI’s co-branding partners. You may avoid sharing your information with BDI’s partners on co-branded sites or service by choosing not to use them. Each co-branding partner will have its own privacy policy and its privacy practices may differ from this Privacy Policy.
Data obtained through text messaging short code programs will not be shared with any third-parties for their marketing reasons/purposes.
Social Media Plugins. When you use the Services, Social Media operators can place a cookie on your computer to recognize individuals who have previously visited the Services. If you are logged into a Social Media account while using the Services, the social plugins allow that Social Media to receive information that you have accessed and used the Services. The social plugins also allow the Social Media operator to share information about your activities in or through the Services with other Social Media users. For example, Facebook Social Plugins allows Facebook to show your Likes and comments on our pages to your Facebook friends. Facebook Social Plugins also allows you to see your friends’ Facebook activity through the Services. BDI does not control any of the content from the Social Media plugins. For more information about Social Media plugins, please refer to the privacy statements and other legal notices of the Social Media platform.
Legal Requirements. In certain circumstances, BDI may release your Personal Information in response to a court order, subpoena, search warrant, regulation, binding order of a data protection agency, governmental request or other legal or regulatory process. BDI may disclose information if we believe disclosure is necessary or appropriate to protect the rights, property, or safety of BDI and our customers or others.
Corporate Changes. We may transfer information, including your Personal Information, in connection with a merger, sale, acquisition, divestiture, restructuring, reorganization, dissolution, bankruptcy or other change of ownership or control by BDI or any affiliated company (in each case, whether in whole or in part). When one of these events occurs, BDI will use reasonable efforts to notify users before information is transferred or becomes subject to different privacy practices.
IV DIGITAL ADVERTISING
We use third-party advertising companies to serve ads on other websites and digital services. These companies may use information obtained from data collection tools in order to measure advertising effectiveness and to provide advertisements of interest to you.
You can opt out here or if you are located in the European Union, by clicking here so as not to receive targeted ads from use of the tools, but this will not affect any general advertisements you may receive..
V. LINKS TO OTHER WEBSITES/SERVICES
A link to a third-party website or digital service does not mean that BDI endorses it or the quality or accuracy of information presented on it. If you decide to visit a third-party website or service, you are subject to its privacy practices and not this Privacy Policy. We encourage you to carefully read the privacy policy or statement and other legal notices of each website or service that you visit.
VI. OUR CHILDREN’S POLICY
The Services are not intended for use by children. If you are under the age of majority in your place of residence, you may use the Services only with the consent of or under the supervision of your parent or legal guardian. Consistent with the requirements of the Children’s Online Privacy Protection Act (COPPA), if we learn that a child under age 13 has provided Personal Information to or through the Services without first receiving his or her parent’s verified consent, we will use that information only to respond directly to that child (or his or her parent or legal guardian) to inform the child that he or she cannot use the Services and subsequently we will dispose of such Personal Information in accordance with this Privacy Policy.
If you believe BDI may have any information from or about a child under age 13, please contact our Privacy Office using the contact information at the end of this Privacy Notice.
VII. YOUR PRIVACY CHOICES
BDI aims to provide you with choices regarding the Personal Information you provide to us. This section describes mechanisms that we offer you to control certain uses and disclosures of your information.
When you access any interactive Service, you will be asked to affirmatively choose (“opt in“) to provide the requested information. You may always choose not to provide the requested information but then you may not be able to use the Service as intended.
Correct/Update Personal Information. You may correct or update the Personal Information you previously provided to BDI, by sending an email to privacy@diag.bracco.com.
Receive Marketing Communications. When you register for the Services, you may request to receive email containing information about BDI that we think you might find useful, including promotions, announcements of new services and products, and newsletters on particular health topics. If you decide, at any time, that you no longer wish to receive these emails you may unsubscribe from our email list by clicking the “unsubscribe” link included in all of our marketing emails. You may also opt-out from receiving these emails by contacting us at privacy@diag.bracco.com.
Accept and Reject Cookies. Your browser software can be set to reject all cookies, but if you reject our cookies, certain of the functions and conveniences of the Services may not work properly. To learn more about cookies, please check your browser’s help or similar feature or visit allaboutcookies.org.
How We Respond to Browser “Do Not Track” Signals. Some web browsers incorporate a “do-not-track” or similar feature that signals to websites with which the browser communicates that a visitor does not want to have his/her online activity tracked. If a digital service that responds to a particular DNT signal receives the DNT signal, the browser can block that digital service from collecting certain Personal Information about the browser’s user. As of the Effective Date not all browsers offer a DNT option and DNT signals are not yet uniform. For this reason, BDI along with many other digital service operators do not currently respond to DNT signals. For more information about DNT signals, visit allaboutdnt.com.
IMPORTANT NOTE: BDI cannot comply with a consumer’s request to amend or remove information that was provided to BDI by a healthcare professional or a consumer regarding an adverse drug event.
VIII. HOW INFORMATION IS RETAINED AND SECURED
We retain information as long as it is necessary and relevant for our operations. In addition, we retain Personal Information to comply with applicable law, prevent fraud, resolve disputes, troubleshoot problems, assist with any investigation, enforce our Terms of Service, and other actions permitted by law. When your Personal Information is no longer needed for BDI’s business purposes, we dispose of it subject to applicable law.
In accordance with applicable laws, we employ reasonable security measures intended to help protect the security of all information submitted through the Services. The security of information transmitted through the internet cannot, however, be guaranteed. We are not responsible for any interception or interruption of any communications or for changes to or losses of data through the internet. Users of the Services are responsible for maintaining the security of any password, user ID or other form of authentication involved in obtaining access to password protected or secure areas of the Services. Any access to the Services through your user ID and password will be treated as authorized by you. To help protect your Personal Information, we may suspend your use of all or part of the Services, without notice, if BDI suspects or detects any breach of security. Unauthorized access to such areas is prohibited and may lead to criminal prosecution.
IX. CHANGES TO THIS PRIVACY POLICY
BDI reserves the right to change the terms of this Privacy Policy. If we make any material changes to this Privacy Policy, we will notify you in advance through the Services. If we decide to use Personal Information in a manner that is materially different from the uses described in this Privacy Policy or otherwise disclosed to you, you will have the choice to allow or disallow any additional uses or disclosures of your Personal Information. We will not make retroactive changes that reduce your privacy rights unless we are legally required to do so. Your continued use of the Services after the Effective Date constitutes your acceptance of the amended Privacy Policy. The amended Privacy Policy supersedes all previous versions.
X. YOUR CALIFORNIA PRIVACY RIGHTS
If you are a California resident under age 18 and are a registered user of any of the Services, then you may request that we remove any of your User Contributions (defined in Section II) you publicly posted on or in the Services. To request removal of your User Contribution, please send a request with a detailed description of the specific User Contribution to the Privacy Office at the contact information below. (You also may be able to log in to your account and delete your own User Contribution.) BDI reserves the right to request that you provide information that will enable us to confirm that the User Contribution that you want removed was created and posted by you.
BDI will make a good faith effort to delete or remove your User Contribution from public view as soon as reasonably practicable. Please note, however, that your request that we delete your User Contribution does not ensure complete or comprehensive removal of your User Contribution. Your User Contribution may remain on backup media, cached or otherwise retained by BDI for administrative or legal purposes or your User Contribution may remain publicly available if you or someone else has forwarded or re-posted your User Contribution on another website or service prior to its deletion. BDI may also be required by law to not remove (or allow removal) of your User Contribution.
California Civil Code Section 1798.83 permits individual California residents to request certain information regarding BDI’s disclosure of personal information to third parties for their direct marketing purposes. To make such a request, please write or send an email to the address below.
California Consumer Privacy Act – Notice for California Residents
If you are a California resident, this Privacy Notice supplements the information above regarding the collection, use, and disclosure of your personal information.
The California Consumer Privacy Act of 2018 (CCPA) gives California consumers the right to know what personal information is collected about them, how it will be used and to whom it is disclosed. The CCPA gives California consumers the right to request access to and deletion of their personal information, and the right to request that their personal information not be sold to the extent applicable under the CCPA.
The purpose of this notice is to describe our practices regarding the collection, use, disclosure, and sale of personal information and instructions for submitting CCPA data privacy requests. Some of the Personal information that we collect, use, and disclose may be exempt from the CCPA because it is regulated by other federal and state laws that apply to us.
We collect personal information from you when you interact with us online through our Services or offline. The personal information we may collect from you will depend on the nature of our interaction with you, but can include the following categories that we have collected in the preceding twelve (12) months:
Personal Information Category
“Personal information” under the CCPA does not include information that is
For additional information, please see our Privacy Policy.
Categories of Sources of Personal Information
We obtain the categories of personal information listed above from the following categories of sources:
Use or Disclosure of Personal Information
In the past 12 months, we have used or disclosed the personal information we collect for our operational purposes and for one or more of the following business purposes:
How We Share Personal Information
Bracco will not share consumers’ personal information with an unrelated third party without permission, except as described below. Bracco may share personal information with any member of our corporate group, including parent companies, subsidiaries, and affiliates, and other companies in which we have an ownership or economic interest for purposes that are consistent with those identified in our Privacy Policy and this Supplemental Privacy Notice.
In the ordinary course of business, we will share some personal information with companies that we hire to perform services or functions on our behalf. In all cases in which we share consumers’ personal information with a third party, we will only allow them to keep, disclose, or use consumers’ information to provide the services we asked them to provide.
We may be required to release consumers’ personal information in response to a court order, subpoena, search warrant, law, or regulation. We may cooperate with law enforcement authorities in investigating and prosecuting users who violate our rules or engage in behavior which is harmful to other users or illegal. In addition, we may keep, disclose, and use consumers’ personal information in order to comply with U.S. FDA and other governmental guidance, directions, regulations, and laws.
Categories of Personal Information We Sell
We do not sell personal information of California consumers except as part of a sale, merger, dissolution, or acquisition of the business.
This does not include disclosures that are not a “sale” under the CCPA, including when
Personal Information on Minors
We do not sell personal information of California consumers, including minors.
Your Rights Under California Law
The CCPA provides you (as a California resident) with specific rights subject to certain exceptions.
How to Submit a Data Privacy Request
If you are a California resident and you want to submit a request or inquiry to us regarding your California rights, you or your authorized agent can contact us as follows:
privacy@diag.bracco.com
Bracco Diagnostics Inc.
c/o Data Protection Focal Point
Legal and Compliance Department
259 Prospect Plains Road, Building H
Monroe Township, New Jersey 08831
609-514-2203
You do not have to create an account with us to submit a request.
Your request will be confirmed within 10 days of receipt and we will respond within 30 days. If we need more than 30 days, we will notify you that your request is being delayed.
We can only respond to your request if it is verifiable. This means we are obligated to take reasonable steps to verify your identity or your authorized agent’s authority and your right to access the information you request. We may ask for additional information that will help us do so. We will only use that additional information in the verification process, and not for any other purpose.
We do not charge a fee to process or respond to your verifiable consumer request unless it is excessive, repetitive, or manifestly unfounded. If we determine that the request warrants a fee, we will tell you why we made that decision and provide you with a cost estimate before completing your request.
XI. NEVADA RESIDENTS AS COVERED BY NEVADA PRIVACY LAW
BDI does not sell Covered Information as defined under Nevada law. If you would like to make a further inquiry regarding the selling of your Covered Information, as defined under Nevada law, please send an email to the Privacy Office at the email address provided below.
Contact Us
privacy@diag.bracco.com
Bracco Diagnostics Inc.
c/o Data Protection Focal Point
Legal and Compliance Department
259 Prospect Plains Road, Building H
Monroe Township, New Jersey 08831
609-514-2203
Be sure to include your name, address, and email address if you want to receive a response by email. Otherwise, we will respond by postal mail within the time required by applicable law.
Effective Date: August 1, 2022
LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use
Indications
LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use is an ultrasound contrast agent indicated for use:
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres. Most serious reactions occur within 30 minutes of administration.
Contraindications
LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use is contraindicated in patients with known or suspected hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG).
Warnings
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or shortly following administration of ultrasound contrast agents, including LUMASON. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to LUMASON administration and monitor all patients for acute reactions.
Post-marketing hypersensitivity reactions, including serious hypersensitivity reactions, have been observed during use or shortly following LUMASON administration. These reactions may occur in patients with no history of prior exposure to sulfur hexafluoride lipid-containing microspheres. LUMASON contains PEG. There may be increased risk of serious reactions including death in patients with prior hypersensitivity reaction(s) to PEG.
Systemic embolization may occur in patients with cardiac shunts. Assess patients with cardiac shunts for embolic phenomena following LUMASON administration.
There is a risk of ventricular arrhythmia related to high mechanical index in patients administered LUMASON. LUMASON is not recommended for use at mechanical indices greater than 0.8.
The most common adverse reactions (incidence ≥ 0.5%) are headache (1%) and nausea (0.5%).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full Prescribing Information for LUMASON ultrasound contrast agent, including BOXED WARNING on Serious Cardiopulmonary Reactions.
LUMASON is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831 by Bracco Suisse S.A., Plan-les-Ouates Geneve, Switzerland (LUMASON lyophilized powder vial-25 mg lipid-type A/60.7 sulfur hexafluoride gas); Vetter Pharma-Fertigung GmbH & Co. KG, 88212 Ravensburg, Germany (Sodium Chloride 0.9% Injection, USP); B. Braun Melsungen AG, 34212 Melsungen, Germany (Mini-Spike).
LUMASON is a registered trademark of Bracco Diagnostics Inc.
Bracco Diagnostics Inc.
259 Prospect Plains Road, Building H
Monroe Township, NJ 08831 USA
Phone: 609-514-2200
Toll Free: 1-877-272-2269 (U.S. only)
Fax: 609-514-2446
© 2022 Bracco Diagnostics Inc. All Rights Reserved. US-LUM-2000052 06/21
IMPORTANT SAFETY INFORMATION | INDICATIONS AND USAGE
LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres. Most serious reactions occur within 30 minutes of administration.