FDA Medical Devices @FDADeviceInfo Twitter profile

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FDA Medical Devices

@FDADeviceInfo

1 year

Today, @US_FDA updated our SARS-CoV-2 Viral Mutations: Impact on #COVID -19 Tests web page to add DxTerity SARS-CoV-2 RT PCR CE Test as a test expected to have reduced performance for the SARS-CoV-2 Omicron Variant and Sub-Variants.

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FDA Medical Devices

@FDADeviceInfo

4 years

Today, the Agency permitted the marketing of EndeavorRx, the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD).

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FDA Medical Devices

@FDADeviceInfo

2 years

Today, the @US_FDA is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, whether or not you have symptoms. Find out more:

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FDA Medical Devices

@FDADeviceInfo

4 years

EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. Find out more

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FDA Medical Devices

@FDADeviceInfo

3 years

Today, the @US_FDA is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test.

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FDA Medical Devices

@FDADeviceInfo

4 years

All hands and supplies are on deck in the fight against #COVID19 . Today @US_FDA ’s CDRH sent our supply of gloves, masks, gowns, and N95 respirators from our Office of Science and Engineering Laboratories to the Clinical Center at @NIH .

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FDA Medical Devices

@FDADeviceInfo

1 year

Did you know you can very easily report your at-home test result for #COVID19 at ? Today, the @US_FDA updated its step-by-step guide to include information about why this is important. Find out more: .?utm_source=CDRHTwitterD

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FDA Medical Devices

@FDADeviceInfo

4 years

Today, the @US_FDA launched the Digital Health Center of Excellence (DHCoE.) The DHCoE seeks to empower digital health stakeholders to advance healthcare by fostering responsible and high-quality digital health innovation.

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FDA Medical Devices

@FDADeviceInfo

7 years

Do not swim while wearing contacts. There is a risk of eye infection frm bacteria in pools, hot tubs, lakes & ocean. #SpringBreak2017

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FDA Medical Devices

@FDADeviceInfo

4 years

Have questions about device shortages, enforcement policies, and other #COVID19 related topics? Check out the @US_FDA ’s comprehensive directory of email addresses for medical device questions during the #COVID19 pandemic.

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FDA Medical Devices

@FDADeviceInfo

2 years

On April 14, 2022, the FDA issued an emergency use authorization (EUA) for InspectIR COVID-19 Breathalyzer, a #COVID19 diagnostic test that uses breath samples to detect SARS-CoV-2. Find out more.

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FDA Medical Devices

@FDADeviceInfo

3 years

The @US_FDA issued an emergency use authorization #EUA for the 11th over-the-counter COVID-19 test➡️ the Detect Covid-19 Test, an OTC #COVID19 diagnostic molecular test.

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FDA Medical Devices

@FDADeviceInfo

3 years

The @US_FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. Since the start of the pandemic, we have authorized over 300 tests and collection kits.

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FDA Medical Devices

@FDADeviceInfo

1 year

Many at-home #COVID19 tests have expiration dates that have been extended! Check if your @US_FDA authorized at-home COVID-19 test has a new expiration date.

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FDA Medical Devices

@FDADeviceInfo

4 years

Today the FDA qualified a new Medical Device Development Tool, the Mitre Rubric For Applying the cybersecurity Common Vulnerability Scoring System (CVSS) To Medical Devices. #MDDT

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FDA Medical Devices

@FDADeviceInfo

6 years

FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world. Size is small enough to be used in newborn pediatric patients to treat heart defects #MedicalDevice

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FDA Medical Devices

@FDADeviceInfo

1 year

🗒️Do you have at-home #COVID19 tests that you think are expired? 🗒️Don’t throw those tests away just yet. Many at-home COVID-19 tests have expiration dates that have been extended! 🗒️Check to see if your at-home COVID-19 test has a new expiration date.

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FDA Medical Devices

@FDADeviceInfo

3 years

Today @US_FDA released its first ever Action Plan for Artificial Intelligence/Machine Learning-based Software as a Medical Device. The plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. #DigitalHealth

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FDA Medical Devices

@FDADeviceInfo

6 years

FDA and CMS work together to bring faster access to a breakthrough diagnostic that can help doctors tailor cancer treatments

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FDA Medical Devices

@FDADeviceInfo

5 years

Join @US_FDA on Sept 10, 2019 for a meeting of the Patient Engagement Advisory Committee. During the meeting the committee will discuss and make recommendations on the topic “Cybersecurity in Medical Devices: Communication That Empowers Patients.” #PEAC

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FDA Medical Devices

@FDADeviceInfo

3 years

The @US_FDA recommends that certain high-risk populations avoid getting dental amalgam fillings, if possible and appropriate. These groups may be at greater risk for potential negative effects of mercury vapor (gas) released from dental amalgam fillings.

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FDA Medical Devices

@FDADeviceInfo

3 years

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Ellume recalls #COVID19 Home Test for potential false positive SARS-CoV-2 test results. Find out more:

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FDA Medical Devices

@FDADeviceInfo

1 year

The @US_FDA is warning consumers and health care providers to not use certain lots of recalled SD Biosensor Pilot COVID-19 tests due to contaminated liquid solutions found in the test kit. Affected tests should be thrown away in household trash.

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FDA Medical Devices

@FDADeviceInfo

7 years

Managing Medical Device Cybersecurity in the Postmarket: At the Crossroads of Cyber-safety & Advancing Technology

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FDA Medical Devices

@FDADeviceInfo

3 years

Hurricane season is here and if you use a #MedicalDevice that could be affected by a power outage caused by heavy rain and flooding, the @US_FDA wants you to check out our tips for using a generator to restore power to your device: #HurricaneIda

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FDA Medical Devices

@FDADeviceInfo

5 years

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link: #heartmonth

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FDA Medical Devices

@FDADeviceInfo

3 years

The @US_FDA is participating in the #DigitalHealth collaborative community, an effort to develop best practices and streamline the field’s approaches to measuring health using digital technologies. Find out more:

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FDA Medical Devices

@FDADeviceInfo

3 years

Today is #StarWarsDay ! And @US_FDA is reminding you to be safe when handling any device or toy with lasers. Check out our tips on laser safety. "May The 4th Be with You!"

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FDA Medical Devices

@FDADeviceInfo

2 years

The @US_FDA announces release of “Playbook for Threat Modeling Medical Devices,” developed by @MDICOnline , and @MITRECorp .

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FDA Medical Devices

@FDADeviceInfo

3 years

Suffering summer allergies? Nasal irrigation devices, such as neti pots, can be effective for relieving the symptoms of allergies, sinus infections and other conditions. Make sure to fill them with the appropriate water and clean them properly.

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FDA Medical Devices

@FDADeviceInfo

5 years

Today is #DontFryDay 🍳and the @US_FDA wants to remind you to stay informed about skin safety while being out in the sun and/or tanning 🕶️. Check out the FDA’s information on UV radiation and tanning devices:

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FDA Medical Devices

@FDADeviceInfo

2 years

At-home OTC #COVID19 diagnostic tests play a key role in the fight against COVID-19. Today, the @US_FDA posted a new resource that provides a list of all authorized at-home OTC COVID-19 diagnostic tests.

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FDA Medical Devices

@FDADeviceInfo

7 years

#FDA confirms #cybersecurity vulnerabilities in St. Jude’s implantable cardiac devices & Merlin @home Transmitters

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FDA Medical Devices

@FDADeviceInfo

2 years

Today, the @US_FDA issued a final rule to improve access to safe, effective, and affordable hearing aids for millions of Americans.

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FDA Medical Devices

@FDADeviceInfo

3 years

Today, the @US_FDA issued a safety communication to warn the public to stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography)

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FDA Medical Devices

@FDADeviceInfo

4 years

Flagging: for all developers of tests for SARS-CoV-2. FDA is hosting a virtual Town Hall today (March 6) at 1pm ET to help answer technical questions about development and validation of molecular tests for SARS-CoV-2 and our recently-issued guidance.

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FDA Medical Devices

@FDADeviceInfo

6 years

#FDA issues first report on patient-reported outcomes in medical device premarket submissions and postmarket studies #patientengagement

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FDA Medical Devices

@FDADeviceInfo

3 years

The @US_FDA is investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new.

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FDA Medical Devices

@FDADeviceInfo

8 years

#FDA approves wearable #defibrillator for #children at risk for sudden cardiac arrest #medicaldevice

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FDA Medical Devices

@FDADeviceInfo

3 years

Today, the @US_FDA issued a safety communication to inform patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy under certain circumstances.

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FDA Medical Devices

@FDADeviceInfo

2 years

MedicalDevices

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FDA Medical Devices

@FDADeviceInfo

2 years

If repeat testing is not performed after a negative result, an infection may be missed and people may unknowingly spread the SARS-CoV-2 virus to others, especially if they are not experiencing symptoms.

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FDA Medical Devices

@FDADeviceInfo

6 years

Contact Lens Health Week is here and the FDA and @CDCgov are reminding you of safe measures to ensure proper use of contact lenses. Check out the CDC’s Healthy Habits Mean Healthy Eye video #OnePairTakeCare

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FDA Medical Devices

@FDADeviceInfo

3 years

Patients should talk to their health care provider if they think they were tested with the Curative SARS-Cov-2 test and have concerns about the test results.

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FDA Medical Devices

@FDADeviceInfo

4 years

Today @US_FDA provided market authorization for another ECG mobile app to be used OTC with a consumer wearable device--adding Fitbit to the list of manufacturers--Apple & Samsung--who provide this #DigitalHealth technology to help consumers be more engaged in their health.

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FDA Medical Devices

@FDADeviceInfo

7 months

This is CDRH.

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FDA Medical Devices

@FDADeviceInfo

2 years

Today, the @US_FDA issued a safety communication advising people to stop using Empowered Diagnostics #COVID19 Tests.

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FDA Medical Devices

@FDADeviceInfo

6 years

Save the date & Join the @US_FDA ’s Patient Engagement Advisory Committee on Nov 15th to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. Learn more: #DigitalHealth #PEAC2018

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FDA Medical Devices

@FDADeviceInfo

3 years

The @US_FDA is advising patients & caregivers to keep any consumer electronic devices that may create magnetic interference, such as cell phones & smart watches, at least 6 inches away from implanted medical devices, such as pacemakers and defibrillators:

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FDA Medical Devices

@FDADeviceInfo

2 years

The playbook is an educational resource that discusses best practices for understanding basic threat modeling and processes, and how to apply them to medical devices. Find out more.

Playbook for Threat Modeling Medical Devices | MITRE

The “Playbook for Threat Modeling Medical Devices” was developed to increase knowledge of threat modeling throughout the medical device ecosystem in order to further strengthen the cybersecurity and...

www.mitre.org

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FDA Medical Devices

@FDADeviceInfo

6 months

November is #NationalDiabetesMonth and the FDA wants to remind patients and caregivers to check out our Diabetes resource page to stay informed about diabetes products that have been cleared or approved by the @US_FDA .

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FDA Medical Devices

@FDADeviceInfo

4 years

Today, the @US_FDA issued a draft guidance, Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.

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FDA Medical Devices

@FDADeviceInfo

6 years

Today is #StarWarsDay . Check out our information on laser safety. "May The 4th Be with You!"

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FDA Medical Devices

@FDADeviceInfo

7 years

#FDA approves implantable device to treat moderate to severe central sleep apnea #medicaldevice

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FDA Medical Devices

@FDADeviceInfo

2 years

The @US_FDA is warning health care providers, parents and caregivers of pediatric patients that there is a risk of strangulation with the use of enteral feeding tube delivery sets.

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FDA Medical Devices

@FDADeviceInfo

7 years

FDA Sets Inaugural Meeting of First-Ever Patient Engagement Advisory Committee

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FDA Medical Devices

@FDADeviceInfo

8 months

Reminder: Advancing Health Equity in #MedicalDevices is the Patient Engagement Advisory Committee- #PEAC2023 topic of discussion. The @US_FDA will host this virtual meeting on Wednesday, September 6, 2023, 10 a.m. – 5:20 p.m. ET. Find out more

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FDA Medical Devices

@FDADeviceInfo

8 years

Learn about 3D printing of medical devices #fda #medicaldevice #3dprinting

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FDA Medical Devices

@FDADeviceInfo

10 months

The @US_FDA is informing consumers on the risk of delayed onset inflammation near dermal filler treatment sites following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Find out more:

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FDA Medical Devices

@FDADeviceInfo

9 months

. @US_FDA is warning consumers & patients not to use tests by Universal Meditech, Inc. The company has notified us that it has stopped all operations and is no longer providing support for its tests. We are unable to confirm the performance of these tests.

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FDA Medical Devices

@FDADeviceInfo

6 years

@US_FDA works with technology companies to help them develop and test new #DigitalHealth products, like #Apple ’s new mobile medical apps for the Apple Watch. For more information about these innovations, click the link: #FDAinnovates #MedicalDevice

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FDA Medical Devices

@FDADeviceInfo

1 year

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Abbott is recalling the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems.

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FDA Medical Devices

@FDADeviceInfo

2 years

The @US_FDA will host a virtual workshop on Building Medical Device Supply Chain Resilience on June 7 -9, 2022, from 1-4 pm ET. Members of group purchasing organizations, manufacturers, clinicians, patients, and the general public are welcome to attend.

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FDA Medical Devices

@FDADeviceInfo

3 years

Check out the latest @Health_Affairs blog, where CDRH’s Jeff Shuren and Timothy Stenzel discuss the role that #COVID19 test development is playing in shifting the testing landscape to increase access and ensure reliability.

Bending The Arc Of COVID-19 Test Development To Increase Access And Ensure Reliability—Now And In...

Lessons learned from our experiences with COVID-19 could be leveraged to facilitate a large-scale effort for swift, widespread access to accurate and reliable tests for a variety of diseases. They...

www.healthaffairs.org

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FDA Medical Devices

@FDADeviceInfo

8 years

#FDA launches website 2 help sponsors & innovators bring safe & effective neurological devices 2 market #sfn16

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FDA Medical Devices

@FDADeviceInfo

2 years

Today, the @US_FDA updated the page, At-Home OTC COVID-19 Diagnostic Tests, to include expiration date information to help consumers find the current expiration date for any FDA-authorized at-home OTC #COVID19 diagnostic test.

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FDA Medical Devices

@FDADeviceInfo

6 years

#ICYMI FDA permits marketing of the first medical device to use artificial intelligence to detect greater than a mild level of diabetic retinopathy in the eye of adults who have diabetes. #Diabetes #ArtificialIntelligence #AI #MedicalDevice

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FDA Medical Devices

@FDADeviceInfo

6 years

FDA permits marketing of the first medical device to use artificial intelligence to detect greater than a mild level of diabetic retinopathy in the eye of adults who have diabetes. #Diabetes #ArtificialIntelligence #AI #MedicalDevice

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FDA Medical Devices

@FDADeviceInfo

5 years

When was the last time you called your doctor? Today is #NationalCallYourDoctorDay and the @US_FDA is encouraging women to schedule their annual Well-Woman Exam to help stay healthy.

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FDA Medical Devices

@FDADeviceInfo

1 year

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Arrow International, LLC is recalling the Arrow AutoCAT 2 and the AC3 Intra-Aortic Balloon Pumps due to battery power. not lasting as long as expected.

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FDA Medical Devices

@FDADeviceInfo

2 years

Today, the @US_FDA published a proposed rule to harmonize the Quality System regulation for medical devices with the international consensus standard for medical devices manufacturers - ISO 13485:2016

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FDA Medical Devices

@FDADeviceInfo

3 years

In 2020, we authorized 100+ novel devices, including the first game-based digital therapeutic to improve attention function in children with ADHD and the first cardiac ultrasound software that incorporates artificial intelligence to guide image acquisition. #NPHW

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FDA Medical Devices

@FDADeviceInfo

4 years

Register today for the ISPOR-FDA Summit 2020 on March 31st from 8:30 AM EST to 4:30 PM EST! The @US_FDA and ISPOR will discuss "Using Patient-Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond.” Find out more:

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FDA Medical Devices

@FDADeviceInfo

6 years

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:

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FDA Medical Devices

@FDADeviceInfo

1 year

Do you have a OHC COVID-19 Antigen Self Test, a Flowflex COVID-19 Antigen Home Test, or an InteliSwab COVID-19 Rapid Test?

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FDA Medical Devices

@FDADeviceInfo

1 year

February is #AmericanHeartMonth and the @US_FDA remains committed to providing patients and caregivers with understandable and accessible science-based information about the products we regulate.

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FDA Medical Devices

@FDADeviceInfo

3 years

The FDA has serious concerns about the performance of these tests and believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA. Find out more.

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FDA Medical Devices

@FDADeviceInfo

7 months

Frightening fact: Decorative contact lenses can harm your eyes and cause infections, scratches, and blindness. Protect your vision this #Halloween . Don't buy lenses without a prescription.

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FDA Medical Devices

@FDADeviceInfo

6 years

#DidYouKnow Find out more about FDA approved devices that keep the heart beating #HeartMonth

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FDA Medical Devices

@FDADeviceInfo

3 years

We put patients first—they are the experts on living with their conditions and its treatments. Input from patients can impact the development, evaluation and monitoring of medical devices. Read the latest on our Patient Science and Engagement activities:

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FDA Medical Devices

@FDADeviceInfo

7 years

Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

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FDA Medical Devices

@FDADeviceInfo

6 years

As part of FDA’s ongoing effort to address the epidemic of #opioid addiction, the agency has announced an innovation challenge to spur development of medical devices, including digital health and diagnostic devices, to help combat opioid addiction. #FDAInnovationChallenge

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FDA Medical Devices

@FDADeviceInfo

10 months

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic recalls ICDs and CRT-Ds for risk of low or no energy output during high voltage therapy. Find out more about this #MedicalDevice recall.

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FDA Medical Devices

@FDADeviceInfo

1 year

Today, the @US_FDA provided the latest information about #MedicalDevice reports that are reportedly associated with the breakdown or suspected breakdown of the PE-PUR foam used in the Philips ventilators, BiPAP machines, and CPAP machines. Find out more.

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FDA Medical Devices

@FDADeviceInfo

2 years

Today, the @US_FDA issued the draft guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

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FDA Medical Devices

@FDADeviceInfo

7 years

#FDA clears first #neonatal magnetic resonance imaging device

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FDA Medical Devices

@FDADeviceInfo

3 years

Today, the @US_FDA issued an urgent Letter to Health Care Providers about the recall of all Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex).

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FDA Medical Devices

@FDADeviceInfo

2 years

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Getinge is recalling the Datascope/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump due to complaints of fluid leaks. Find out more:

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FDA Medical Devices

@FDADeviceInfo

7 years

#FDA selects participants 4 new digital health software precertification pilot program. #medicaldevice

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FDA Medical Devices

@FDADeviceInfo

7 years

#FDA clears expanded use of cooling cap to reduce hair loss during #chemotherapy #medicaldevice

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FDA Medical Devices

@FDADeviceInfo

3 years

Your contact solution matters. Incorrect use of lens solutions can increase your risk of eye infections and corneal ulcers, which can cause blindness. Read about how to reduce your risk of infection with contact lenses. #SaveYourVisionMonth

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FDA Medical Devices

@FDADeviceInfo

8 months

FDA and @fema remind you if you need to reuse a #MedicalDevice that is intended for multiple uses, it must be disinfected or sterilized according to manufacturer’s instructions. Visit us for #NPM2023 tips.

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FDA Medical Devices

@FDADeviceInfo

5 years

THREAD: Since 2017, @SGottliebFDA has supported CDRH’s initiatives to protect and promote public health and to advance device safety and innovation.

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FDA Medical Devices

@FDADeviceInfo

2 years

FDA continues to facilitate technological innovations. New @US_FDA Draft Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders:

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FDA Medical Devices

@FDADeviceInfo

3 years

Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients.

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FDA Medical Devices

@FDADeviceInfo

6 years

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: #MedicalDevice

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FDA Medical Devices

@FDADeviceInfo

3 years

The @US_FDA issued a safety communication to warn the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. We have significant concerns that the performance of the test has not been adequately established, presenting a risk to health.

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FDA Medical Devices

@FDADeviceInfo

5 years

Congrats to our very own Bakul Patel!

Bakul Patel

@_bakulpatel

5 years

I’m humbled to be named in @StatNews ’ five names to know in digital therapeutics. And congrats to my #digitalhealth team: “Experts say the U.S. regulators are way ahead of the game on digital therapeutics compared to their counterparts in Europe.”

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FDA Medical Devices

@FDADeviceInfo

5 years

If you were planning to have mesh placed transvaginally for the repair of pelvic organ prolapse, discuss other treatment options with your doctor and check out the #FDA 's order: #FDA #MedicalDevice

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FDA Medical Devices

@FDADeviceInfo

2 years

Today, the @US_FDA issued the final guidance Clinical Decision Support Software. The guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals.

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