On May 30th, the @US_FDA identified a Class I Recall, the most serious type of recall: Terumo Medical Corporation Recalls SOLOPATH ® Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System: https://go.usa.gov/xmH6g   pic.twitter.com/vEMrDEvLUW
On May 30th, the @US_FDA identified a Class I Recall, the most serious type of recall: Terumo Medical Corporation Recalls SOLOPATH® Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System: https://go.usa.gov/xmH6g  pic.twitter.com/vEMrDEvLUW (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 31, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The comment period has been extended for the draft guidance for industry entitled “ Review and Update of Device Establishment Inspection Processes and Standards. ” The @US_FDA is asking you to submit either electronic or written comments by June 27, 2019: https://go.usa.gov/xmHHG   pic.twitter.com/8URfRIBbGT
The comment period has been extended for the draft guidance for industry entitled “Review and Update of Device Establishment Inspection Processes and Standards.” The @US_FDA is asking you to submit either electronic or written comments by June 27, 2019: https://go.usa.gov/xmHHG  pic.twitter.com/8URfRIBbGT (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 31, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA is encouraging you to submit your comments by June 3rd to the recent discussion paper on a potential #TPLC approach to regulating #artificialintelligence and #machinelearning software as a medical device: https://www.regulations.gov/document?D=FDA-2019-N-1185-0001   … #digitalhealth #healthtech
. @US_FDA is encouraging you to submit your comments by June 3rd to the recent discussion paper on a potential #TPLC approach to regulating #artificialintelligence and #machinelearning software as a medical device: https://www.regulations.gov/document?D=FDA-2019-N-1185-0001 … #digitalhealth #healthtech (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 31, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Artificial intelligence (AI)- and machine learning (ML)-based technologies have the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of healthcare every day
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 31, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Thank you to everyone at who participated in the @US_FDA Small Business 2019 #REdI conference!pic.twitter.com/031yVudDdE
Thank you to everyone at who participated in the @US_FDA Small Business 2019 #REdI conference! pic.twitter.com/031yVudDdE (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 31, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Are you ready for Hurricane season? Plan ahead to keep your food & water safe and reduce the risk of foodborne illness if the power goes out or flooding occurs! Helpful prep steps here > > https://www.pinterest.com/pin/381680137146024610/   … Wouldn't this look great on your fridge?pic.twitter.com/nCPsfmeKgJ
Are you ready for Hurricane season? Plan ahead to keep your food & water safe and reduce the risk of foodborne illness if the power goes out or flooding occurs! Helpful prep steps here>> https://www.pinterest.com/pin/381680137146024610/ … Wouldn't this look great on your fridge? pic.twitter.com/nCPsfmeKgJ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 30, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

As a voluntary network of data partners, NEST relies on engagement with the broader medical device ecosystem — including industry players, health systems, patient groups, clinician groups, payers, and regulators — to achieve its mission.
As a voluntary network of data partners, NEST relies on engagement with the broader medical device ecosystem—including industry players, health systems, patient groups, clinician groups, payers, and regulators—to achieve its mission. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA encourages you to share your comments on the Methods and Data Quality Frameworks which have been posted on the NESTcc website by June 21st: https://nestcc.org/opportunities/  
The @US_FDA encourages you to share your comments on the Methods and Data Quality Frameworks which have been posted on the NESTcc website by June 21st: https://nestcc.org/opportunities/  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On Monday June 3rd from 2:30-3 PM EST, we also encourage you to join @NESTccMedTech for a public webinar discuss its Data Quality and Methods Protocol Frameworks. More information, including a registration link, can be found here: https://nestcc.org/events/nestcc-framework-public-webinar/   …
On Monday June 3rd from 2:30-3 PM EST, we also encourage you to join @NESTccMedTech for a public webinar discuss its Data Quality and Methods Protocol Frameworks. More information, including a registration link, can be found here: https://nestcc.org/events/nestcc-framework-public-webinar/ … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The National Evaluation System for health Technology (NEST) works to more efficiently generate better evidence for medical device evaluation and regulatory decision-making.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Do you help provide care for a family member or loved one? Check out these tips: http://www.fda.gov/caregivertips   pic.twitter.com/WxaUTRmHBH
Do you help provide care for a family member or loved one? Check out these tips: http://www.fda.gov/caregivertips  pic.twitter.com/WxaUTRmHBH (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2019 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

The @US_FDA's #REdI conference is here! We are looking forward to exciting and informative presentations and speakers, including our keynote speaker: Dr. Bill Maisel, Director of Product Evaluation and Quality. Join the conference virtually: https://www.sbiaevents.com/redi2019/   pic.twitter.com/n6JtILOkXu
The @US_FDA's #REdI conference is here! We are looking forward to exciting and informative presentations and speakers, including our keynote speaker: Dr. Bill Maisel, Director of Product Evaluation and Quality. Join the conference virtually: https://www.sbiaevents.com/redi2019/  pic.twitter.com/n6JtILOkXu (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Take care of your skin on #DontFryDay and everyday w/ these tips on everything from sunscreen to sunglasses! https://go.usa.gov/xmdaB   pic.twitter.com/YCUFh3Xf49
Take care of your skin on #DontFryDay and everyday w/ these tips on everything from sunscreen to sunglasses! https://go.usa.gov/xmdaB  pic.twitter.com/YCUFh3Xf49 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 24, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

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: https://go.usa.gov/xmwHg   pic.twitter.com/Tv2tQsuWjx
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: https://go.usa.gov/xmwHg  pic.twitter.com/Tv2tQsuWjx (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 24, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The clearance of the modified ERBEFLO 24-hour use port connector provides another option for health care facilities whose staff understand and can fully implement the instructions for use to reduce the risk of cross-contamination and infection. #medicaldevice
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 24, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On May 23rd, the @US_FDA issued an updated Letter to Health Care Providers announcing clearance of a modified Erbe USA Inc. (ERBE) ERBEFLO port connector designed to help reduce the risk of cross-contamination: https://go.usa.gov/xmGuK   pic.twitter.com/GYmcRIsezO
On May 23rd, the @US_FDA issued an updated Letter to Health Care Providers announcing clearance of a modified Erbe USA Inc. (ERBE) ERBEFLO port connector designed to help reduce the risk of cross-contamination: https://go.usa.gov/xmGuK  pic.twitter.com/GYmcRIsezO (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 24, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA is calling for software manufacturers to volunteer to be part of the FDA ’ s test plan for the Software #PreCert Program. Read more about how to participate here: https://go.usa.gov/xmfRZ   #DigitalHealth #HealthTechpic.twitter.com/kX39XCa5FX
. @US_FDA is calling for software manufacturers to volunteer to be part of the FDA’s test plan for the Software #PreCert Program. Read more about how to participate here: https://go.usa.gov/xmfRZ  #DigitalHealth #HealthTech pic.twitter.com/kX39XCa5FX (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 22, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Are you an excellent software developer and planning to submit a De Novo or 510(k) submission for your software as a medical device in 2019? #DigitalHealth #HealthTech
Are you an excellent software developer and planning to submit a De Novo or 510(k) submission for your software as a medical device in 2019? #DigitalHealth #HealthTech (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 22, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The unique device identifier (UDI) for medical devices will ultimately improve patient safety, modernize post-market surveillance, and facilitate innovation. The FDA issued the first warning letter for UDI violations to help ensure compliance. Read more: https://go.usa.gov/xmw74  
The unique device identifier (UDI) for medical devices will ultimately improve patient safety, modernize post-market surveillance, and facilitate innovation. The FDA issued the first warning letter for UDI violations to help ensure compliance. Read more: https://go.usa.gov/xmw74  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 21, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

For more information on complying with UDI requirements, including providing required information to the Global Unique Device Identification Database (GUDID), visit our website. http://www.fda.gov/udi   #FDA #MedicalDevice
For more information on complying with UDI requirements, including providing required information to the Global Unique Device Identification Database (GUDID), visit our website. http://www.fda.gov/udi  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 21, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA is sharing the latest interim post-approval study results for Abiomed ’ s Impella RP System. https://go.usa.gov/xmwwN   #MedicalDevicepic.twitter.com/L5v7V82MLw
The @US_FDA is sharing the latest interim post-approval study results for Abiomed’s Impella RP System. https://go.usa.gov/xmwwN  #MedicalDevice pic.twitter.com/L5v7V82MLw (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 21, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Make your next vacation a healthy one with these 5 tips: https://go.usa.gov/xmkq4   pic.twitter.com/kdeA5QE3aF
Make your next vacation a healthy one with these 5 tips: https://go.usa.gov/xmkq4  pic.twitter.com/kdeA5QE3aF (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 21, 2019 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

REMINDER: On May 21, 2019 from 3-4:30 p.m EST, the @US_FDA will host a webinar on the Unique Device Identification Convenience Kits final guidance. Registration is not necessary. Find out more about the upcoming webinar: https://go.usa.gov/xmkYR   #FDA #MedicalDevicepic.twitter.com/YYtmJIRiZK
REMINDER: On May 21, 2019 from 3-4:30 p.m EST, the @US_FDA will host a webinar on the Unique Device Identification Convenience Kits final guidance. Registration is not necessary. Find out more about the upcoming webinar: https://go.usa.gov/xmkYR  #FDA #MedicalDevice pic.twitter.com/YYtmJIRiZK (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 20, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK https://twitter.com/US_FDA/status/1130458151390765057   …
#DYK https://twitter.com/US_FDA/status/1130458151390765057 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 20, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI On May 16th, the @US_FDA identified a Class I Recall, the most serious type of recall: Ethicon recalls circular staplers for insufficient firing and failure to completely form staples. Find out more about the recall: https://go.usa.gov/xmd8Y   #FDA #MedicalDevicepic.twitter.com/Lc79LdjWhc
#ICYMI On May 16th, the @US_FDA identified a Class I Recall, the most serious type of recall: Ethicon recalls circular staplers for insufficient firing and failure to completely form staples. Find out more about the recall: https://go.usa.gov/xmd8Y  #FDA #MedicalDevice pic.twitter.com/Lc79LdjWhc (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 17, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Patients and caregivers should be aware of diabetes management devices that have not been reviewed by the @US_FDA for use alone or along with other devices. Inaccurate glucose level readings or unsafe insulin dosing may result, which can lead to injury or death.pic.twitter.com/tPMH8bPyTZ
Patients and caregivers should be aware of diabetes management devices that have not been reviewed by the @US_FDA for use alone or along with other devices. Inaccurate glucose level readings or unsafe insulin dosing may result, which can lead to injury or death. pic.twitter.com/tPMH8bPyTZ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 17, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, @US_FDA issued a Safety Communication, warning against the use of devices for diabetes management not authorized for sale in the US. https://go.usa.gov/xmdjA   #MedicalDevicepic.twitter.com/Y40fuwXqh8
Today, @US_FDA issued a Safety Communication, warning against the use of devices for diabetes management not authorized for sale in the US. https://go.usa.gov/xmdjA  #MedicalDevice pic.twitter.com/Y40fuwXqh8 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 17, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

SAFETY ALERT: FDA is advising consumers, tattoo artists & retailers to avoid using/selling 6 recalled tattoo inks contaminated w/ bacteria that can cause infections & lead to serious health injuries when injected into the skin during a tattooing procedure. https://go.usa.gov/xmVn7   pic.twitter.com/hzJ6PM6tFZ
SAFETY ALERT: FDA is advising consumers, tattoo artists & retailers to avoid using/selling 6 recalled tattoo inks contaminated w/ bacteria that can cause infections & lead to serious health injuries when injected into the skin during a tattooing procedure. https://go.usa.gov/xmVn7  pic.twitter.com/hzJ6PM6tFZ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 16, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Today, the @US_FDA shared an update on medical device reports and ongoing manufacturer ’ s postmarket surveillance study for #Essure. Find out more: https://go.usa.gov/xmV7w  
Today, the @US_FDA shared an update on medical device reports and ongoing manufacturer’s postmarket surveillance study for #Essure. Find out more: https://go.usa.gov/xmV7w  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

As the @US_FDA celebrates National Women ’ s Health Week, we want to remind women that thermography should not be used in place of mammography to detect, diagnose, or screen for breast cancer. Find out more: https://go.usa.gov/xmyfW   #NWHWpic.twitter.com/EIMAfXMpZR
As the @US_FDA celebrates National Women’s Health Week, we want to remind women that thermography should not be used in place of mammography to detect, diagnose, or screen for breast cancer. Find out more: https://go.usa.gov/xmyfW  #NWHW pic.twitter.com/EIMAfXMpZR (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

National Women ’ s Health Week serves as a reminder for women to make their health a priority and build positive health habits for life. #NWHWpic.twitter.com/D0R9Xy0Wue
National Women’s Health Week serves as a reminder for women to make their health a priority and build positive health habits for life. #NWHW pic.twitter.com/D0R9Xy0Wue (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

During this #NationalWomensHealthWeek #FDAORA offers tips to keep women safe when taking #dietarysupplements including vitamins, minerals, herbs & amino acids. LEARN MORE: https://go.usa.gov/xEhkB   #NWHWpic.twitter.com/hKOuOAhpTS
During this #NationalWomensHealthWeek #FDAORA offers tips to keep women safe when taking #dietarysupplements including vitamins, minerals, herbs & amino acids. LEARN MORE: https://go.usa.gov/xEhkB  #NWHW pic.twitter.com/hKOuOAhpTS (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 15, 2019 Category: Medical Devices Authors: ( at FDA_ORA) Source Type: news

This week we are celebrating National Women ’ s Health Week. Nearly 7 out of 10 U.S. women smokers want to stop smoking completely. Find resources designed for women to help you start being smoke-free today: http://women.smokefree.gov   via @FDATobacco #NWHWpic.twitter.com/HgcLCdwGMk
This week we are celebrating National Women’s Health Week. Nearly 7 out of 10 U.S. women smokers want to stop smoking completely. Find resources designed for women to help you start being smoke-free today: http://women.smokefree.gov  via @FDATobacco #NWHW pic.twitter.com/HgcLCdwGMk (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 14, 2019 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

Great heart health starts with prevention. Many women don ’ t know that heart disease is the leading cause of death for women. This National Women ’ s Health Week, spread the word and learn more about the risk factors: http://www.fda.gov/womenshearthealth   … #NWHWpic.twitter.com/s8dpZGnDAC
Great heart health starts with prevention. Many women don’t know that heart disease is the leading cause of death for women. This National Women’s Health Week, spread the word and learn more about the risk factors: http://www.fda.gov/womenshearthealth … #NWHW pic.twitter.com/s8dpZGnDAC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 14, 2019 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

On May 30, 2019 the @US_FDA will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee from 9 a.m. to 4 p.m. EST in Gaithersburg, MD. **Note the time changed from 10 am as stated in the FR notice to 9 am** #MedicalDevicepic.twitter.com/b5s6gchM9x
On May 30, 2019 the @US_FDA will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee from 9 a.m. to 4 p.m. EST in Gaithersburg, MD. **Note the time changed from 10 am as stated in the FR notice to 9 am** #MedicalDevice pic.twitter.com/b5s6gchM9x (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We are also seeking public input on the proposed reclassification of surgical staplers for internal use from Class I to Class II. We invite any interested parties to participate in the public panel meeting and to submit comments. https://go.usa.gov/xmETH   #FDA #MedicalDevice
We are also seeking public input on the proposed reclassification of surgical staplers for internal use from Class I to Class II. We invite any interested parties to participate in the public panel meeting and to submit comments. https://go.usa.gov/xmETH  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Deadlines: • 5/10: Request to make a formal oral presentation at the panel meeting • 5/20: Submit written comments to the panel • 5/30: Attend the panel meeting in Gaithersburg, MD • 6/24: Submit written comments on the proposed order to reclassify to docket FDA-2019-N-1250
Deadlines: •5/10: Request to make a formal oral presentation at the panel meeting •5/20: Submit written comments to the panel •5/30: Attend the panel meeting in Gaithersburg, MD •6/24: Submit written comments on the proposed order to reclassify to docket FDA-2019-N-1250 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, @US_FDA alerted providers and patients to check for premature battery depletion in certain Medtronic pacemakers and CRT-Ps https://go.usa.gov/xmQVR   #safety #MedicalDevicepic.twitter.com/dMm5kqsy6a
Today, @US_FDA alerted providers and patients to check for premature battery depletion in certain Medtronic pacemakers and CRT-Ps https://go.usa.gov/xmQVR  #safety #MedicalDevice pic.twitter.com/dMm5kqsy6a (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 7, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today is #StarWarsDay 2019! And the @US_FDA is reminding you to be safe when handling any device or toy with lasers. Check out our information on laser safety. " May The 4th Be with You! " https://go.usa.gov/xmRm2   pic.twitter.com/fYhCn4nq5Y
Today is #StarWarsDay 2019! And the @US_FDA is reminding you to be safe when handling any device or toy with lasers. Check out our information on laser safety. "May The 4th Be with You!" https://go.usa.gov/xmRm2  pic.twitter.com/fYhCn4nq5Y (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 4, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Preferential Treatment: US FDA Asks Patients For Their Input http://bit.ly/2H1vJh0   #Medtech
Preferential Treatment: US FDA Asks Patients For Their Input http://bit.ly/2H1vJh0  #Medtech (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 4, 2019 Category: Medical Devices Authors: ( at Medtech_Insight) Source Type: news

#ICYMI The @US_FDA is alerting patients who had a mammogram(s) at East Palestine Family Medical Clinic, located in East Palestine, Ohio, on or after March 28, 2017, about possible problems with the quality of their mammograms. Find out more: https://go.usa.gov/xmR3f   pic.twitter.com/rUtwrLjwQx
#ICYMI The @US_FDA is alerting patients who had a mammogram(s) at East Palestine Family Medical Clinic, located in East Palestine, Ohio, on or after March 28, 2017, about possible problems with the quality of their mammograms. Find out more: https://go.usa.gov/xmR3f  pic.twitter.com/rUtwrLjwQx (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 3, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA announced several new steps we have taken and are considering, aimed at helping to ensure that women have access to the information they need about breast implants. #MedicalDevice
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We are committed to making a difference for women ’ s health & will continue working towards ensuring we understand the benefits and risks of these devices, & that women have the most complete information available to make informed breast implant decisions. https://go.usa.gov/xmNKJ   pic.twitter.com/bNeWGtYe3U
We are committed to making a difference for women’s health & will continue working towards ensuring we understand the benefits and risks of these devices, & that women have the most complete information available to make informed breast implant decisions. https://go.usa.gov/xmNKJ  pic.twitter.com/bNeWGtYe3U (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA is seeking feedback on the Priority List of Patient Preference-Sensitive Areas, to provide clarity to researchers and industry members about areas in which CDRH would find patient preference studies most informative for medical devices. https://go.usa.gov/xmNa6  
The @US_FDA is seeking feedback on the Priority List of Patient Preference-Sensitive Areas, to provide clarity to researchers and industry members about areas in which CDRH would find patient preference studies most informative for medical devices. https://go.usa.gov/xmNa6  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We believe that patients can and should bring their experiences to help inform the #FDA ’ s evaluation of medical devices over the total product life cycle.
We believe that patients can and should bring their experiences to help inform the #FDA’s evaluation of medical devices over the total product life cycle. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

As a result, CDRH will expand its work on patient preferences and identify priority areas where patient preference data may help inform regulatory decision-making. https://go.usa.gov/xmNaS   #Patients #MedicalDevice
As a result, CDRH will expand its work on patient preferences and identify priority areas where patient preference data may help inform regulatory decision-making. https://go.usa.gov/xmNaS  #Patients #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

ALWAYS place a baby on his or her back at night and during nap time. An easy way to remember this is to follow the ABCs of safe sleep: “ Alone on the Back in a bare Crib. " Learn more from the #FDA about safe sleep for babies: https://go.usa.gov/xmXv7   #InfantSafety #Pediatrics
ALWAYS place a baby on his or her back at night and during nap time. An easy way to remember this is to follow the ABCs of safe sleep: “Alone on the Back in a bare Crib." Learn more from the #FDA about safe sleep for babies: https://go.usa.gov/xmXv7  #InfantSafety #Pediatrics (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 30, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@USCPSC recently recalled Rocking Sleepers due to reports of infant deaths. Using a device to hold an infant in a particular position poses a serious suffocation risk and is unnecessary.
. @USCPSC recently recalled Rocking Sleepers due to reports of infant deaths. Using a device to hold an infant in a particular position poses a serious suffocation risk and is unnecessary. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 30, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

I ’ m pleased to announce the new FDA website is LIVE! The site is the gateway to info the public needs to make informed decisions quickly, on topics ranging from recalls to important safety alerts. Check it out at https://www.fda.gov   . #NewFDAgovpic.twitter.com/2fgyE85YME
I’m pleased to announce the new FDA website is LIVE! The site is the gateway to info the public needs to make informed decisions quickly, on topics ranging from recalls to important safety alerts. Check it out at https://www.fda.gov . #NewFDAgov pic.twitter.com/2fgyE85YME (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 29, 2019 Category: Medical Devices Authors: ( at FDACommissioner) Source Type: news

#Recall: 694,000 @KidsII Rocking Sleepers Due to Reports of Infant Deaths. Stop using the product and contact Kids II for a refund or voucher. CONTACT: 866-869-7954 or http://www.kids2.com   . Full recall notice: http://bit.ly/2ILWB6E   pic.twitter.com/JUavnf0HMN
#Recall: 694,000 @KidsII Rocking Sleepers Due to Reports of Infant Deaths. Stop using the product and contact Kids II for a refund or voucher. CONTACT: 866-869-7954 or http://www.kids2.com . Full recall notice: http://bit.ly/2ILWB6E  pic.twitter.com/JUavnf0HMN (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 26, 2019 Category: Medical Devices Authors: ( at USCPSC) Source Type: news