#ICYMI: On February 14th, @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error. Find out more about the recall: https://go.usa.gov/xEUhq   #MedicalDevice #FDApic.twitter.com/YNkrpGSOhH
#ICYMI: On February 14th, @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error. Find out more about the recall: https://go.usa.gov/xEUhq  #MedicalDevice #FDA pic.twitter.com/YNkrpGSOhH (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Read more here: https://go.usa.gov/xEUuM   #MedicalDevice #FDA
#ICYMI: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Read more here: https://go.usa.gov/xEUuM  #MedicalDevice #FDA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu   #MedicalDevice #FDA
Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu  #MedicalDevice #FDA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA issued a warning letter citing safety concerns regarding an illegally marketed device that claims to prevent and treat tightening of scar tissue around breast implants. Read the more about the warning letter here: https://go.usa.gov/xEUks  
Today, the @US_FDA issued a warning letter citing safety concerns regarding an illegally marketed device that claims to prevent and treat tightening of scar tissue around breast implants. Read the more about the warning letter here: https://go.usa.gov/xEUks  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI: Read the statement from Binita Ashar, M.D., of @US_FDA's Center for Devices and Radiological Health on the agency ’ s continuing efforts to educate patients on known risk of lymphoma from breast implants: https://go.usa.gov/xERN3   #MedicalDevice #FDA
#ICYMI: Read the statement from Binita Ashar, M.D., of @US_FDA 's Center for Devices and Radiological Health on the agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants: https://go.usa.gov/xERN3  #MedicalDevice #FDA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 8, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On February 5th, @US_FDA identified a Class I Recall, the most serious type of recall: Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to Incorrect Assembly Causing Reversal of Lumens. Find out more about the recall: https://go.usa.gov/xER5f   #FDA #MedicalDevicepic.twitter.com/6adzC2txTv
On February 5th, @US_FDA identified a Class I Recall, the most serious type of recall: Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to Incorrect Assembly Causing Reversal of Lumens. Find out more about the recall: https://go.usa.gov/xER5f  #FDA #MedicalDevice pic.twitter.com/6adzC2txTv (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 8, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On February 4th, @US_FDA identified a Class I Recall, the most serious type of recall: Medex Cardio-Pulmonary, recalls sterile saline and sterile water for inhalation due to potential exposure to infectious agents as a result of leaking containers: https://go.usa.gov/xER5V   pic.twitter.com/J0onEcDwqE
On February 4th, @US_FDA identified a Class I Recall, the most serious type of recall: Medex Cardio-Pulmonary, recalls sterile saline and sterile water for inhalation due to potential exposure to infectious agents as a result of leaking containers: https://go.usa.gov/xER5V  pic.twitter.com/J0onEcDwqE (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 8, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA issued a Letter to Healthcare Providers about diagnosing and treating BIA-ALCL. Click to read more about the #FDA's recommendations: https://go.usa.gov/xENj4   #MedicalDevicepic.twitter.com/szwLQ8FvxA
Today, the @US_FDA issued a Letter to Healthcare Providers about diagnosing and treating BIA-ALCL. Click to read more about the #FDA's recommendations: https://go.usa.gov/xENj4  #MedicalDevice pic.twitter.com/szwLQ8FvxA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 6, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On January 28th, @US_FDA identified a Class I Recall, the most serious type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions. Find out more about the recall here: https://go.usa.gov/xEXHM   #FDA #MedicalDevicepic.twitter.com/0l5O1bSaUy
On January 28th, @US_FDA identified a Class I Recall, the most serious type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions. Find out more about the recall here: https://go.usa.gov/xEXHM  #FDA #MedicalDevice pic.twitter.com/0l5O1bSaUy (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 4, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On February 1st, @US_FDA classified a Class I Recall, the most serious type of recall: Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results. Find out more here: https://go.usa.gov/xEX7Y   pic.twitter.com/MeFubksqsa
On February 1st, @US_FDA classified a Class I Recall, the most serious type of recall: Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results. Find out more here: https://go.usa.gov/xEX7Y  pic.twitter.com/MeFubksqsa (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 4, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI #FDA #MedicalDevice https://twitter.com/SGottliebFDA/status/1090564837187424258   …
#ICYMI #FDA #MedicalDevice https://twitter.com/SGottliebFDA/status/1090564837187424258 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 1, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI https://twitter.com/SGottliebFDA/status/1090998206798983168   …
#ICYMI https://twitter.com/SGottliebFDA/status/1090998206798983168 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 1, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#HeartMonth https://twitter.com/FDAWomen/status/1091317763203842048   …
#HeartMonth https://twitter.com/FDAWomen/status/1091317763203842048 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 1, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today @US_FDA issued a safety communication to providers and patients about the risks of air-in-line when using infusion pumps, rapid infusers, and fluid warmers. Find out more about the risks and #FDA recommendations: https://go.usa.gov/xE9g7   ##MedicalDevicepic.twitter.com/lLIyoG6680
Today @US_FDA issued a safety communication to providers and patients about the risks of air-in-line when using infusion pumps, rapid infusers, and fluid warmers. Find out more about the risks and #FDA recommendations: https://go.usa.gov/xE9g7  # #MedicalDevice pic.twitter.com/lLIyoG6680 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 31, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On January 23rd, @US_FDA identified a Class I Recall, the most serious type of recall: Draeger Medical Recalls Breathing Circuits and Anesthesia Sets. Read more about the recall: https://go.usa.gov/xEktQ   #FDA #MedicalDevicepic.twitter.com/cJYfk0FUiR
On January 23rd, @US_FDA identified a Class I Recall, the most serious type of recall: Draeger Medical Recalls Breathing Circuits and Anesthesia Sets. Read more about the recall: https://go.usa.gov/xEktQ  #FDA #MedicalDevice pic.twitter.com/cJYfk0FUiR (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On Dec 28, 2018 @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic Recalls Synergy Cranial Software & Stealth Station S7 Cranial Software Due to Inaccuracies Displayed During Surgical Procedures. Read more about the recall: https://go.usa.gov/xEktg   pic.twitter.com/Hspup9pv4p
On Dec 28, 2018 @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic Recalls Synergy Cranial Software & Stealth Station S7 Cranial Software Due to Inaccuracies Displayed During Surgical Procedures. Read more about the recall: https://go.usa.gov/xEktg  pic.twitter.com/Hspup9pv4p (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On January 23rd, @US_FDA permitted the marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium. For more information, read the press release here: https://go.usa.gov/xEkt3   #FDA #MedicalDevice
On January 23rd, @US_FDA permitted the marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium. For more information, read the press release here: https://go.usa.gov/xEkt3  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Send your input on the #FDAPrecertPilot working model by March 8, 2019 https://go.usa.gov/xE2fZ   #DigitalMedicine #HealthTech
Send your input on the #FDAPrecertPilot working model by March 8, 2019 https://go.usa.gov/xE2fZ  #DigitalMedicine #HealthTech (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 7, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/xEaNB   #MedicalDevice
. @US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/xEaNB  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 20, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Following Essure ’ s removal from the market, the FDA will continue to monitor women with device; we ’ re working to implement surveillance system and registries to answer crucial questions on devices for women ’ s health. https://go.usa.gov/xEa9p  
Following Essure’s removal from the market, the FDA will continue to monitor women with device; we’re working to implement surveillance system and registries to answer crucial questions on devices for women’s health. https://go.usa.gov/xEa9p  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 20, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

The use of necklaces, bracelets, & other jewelry marketed for relieving teething pain can lead to serious injuries or death & should not be used to reduce teething pain in infants or to provide sensory stimulation to persons with special needs. Learn more: https://go.usa.gov/xEaWn   pic.twitter.com/RScrgBUSYj
The use of necklaces, bracelets,& other jewelry marketed for relieving teething pain can lead to serious injuries or death & should not be used to reduce teething pain in infants or to provide sensory stimulation to persons with special needs. Learn more: https://go.usa.gov/xEaWn  pic.twitter.com/RScrgBUSYj (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 20, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX   #MedicalDevice #FDApic.twitter.com/sHElqFFODy
Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDA pic.twitter.com/sHElqFFODy (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 19, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The Breakthrough Devices Program ’ s goal is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition.
The Breakthrough Devices Program’s goal is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 19, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit. Find out more about breakthrough devices: https://go.usa.gov/xExHZ  
These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit. Find out more about breakthrough devices: https://go.usa.gov/xExHZ  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 19, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On Dec. 18th, the @US_FDA issued the final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the #breakthrough designation. Read more: https://go.usa.gov/xExHq   pic.twitter.com/fAAZAQx1H5
On Dec. 18th, the @US_FDA issued the final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features, and the process for manufacturers to follow when choosing to pursue the #breakthrough designation. Read more: https://go.usa.gov/xExHq  pic.twitter.com/fAAZAQx1H5 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 19, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383   #MedicalDevice #FDApic.twitter.com/S2EbMdmwpe
On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/S2EbMdmwpe (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 19, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers: https://go.usa.gov/xEx2r   #FDApic.twitter.com/57pZAmSb9r
#DYK December is #SafeToysAndGiftsMonth. Check out @US_FDA's Consumer Update on how to keep kids safe with toys containing lasers: https://go.usa.gov/xEx2r  #FDA pic.twitter.com/57pZAmSb9r (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 18, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE383   #MedicalDevice #FDApic.twitter.com/X4IprwU8R2
GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/X4IprwU8R2 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke   #FDA #MedicalDevice
#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI: Jeff Shuren, Director of the Center for Devices & Radiological Health, released a statement on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data. Read the statement here: https://go.usa.gov/xE3kf   #MedicalDevice
#ICYMI: Jeff Shuren, Director of the Center for Devices & Radiological Health, released a statement on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data. Read the statement here: https://go.usa.gov/xE3kf  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI: @SGottliebFDA issued a statement on the #FDA ’ s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here: https://go.usa.gov/xE3kk   #MedicalDevice
#ICYMI: @SGottliebFDA issued a statement on the #FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here: https://go.usa.gov/xE3kk  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more: https://go.usa.gov/xPShF   #MedicalDevice #FDApic.twitter.com/HiJbgPnsPt
. @US_FDA is emphasizing the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. Read more: https://go.usa.gov/xPShF  #MedicalDevice #FDA pic.twitter.com/HiJbgPnsPt (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 10, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies to advance these effortspic.twitter.com/2co2Hz4jUt
As a science-based agency we rely on evidence generated from data to inform regulatory decisions. #FDA's #SundayTweetorial discusses how we use data from real-world settings to enhance what we know about medical products. This week we'll announce policies to advance these efforts pic.twitter.com/2co2Hz4jUt (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 2, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

.@US_FDA scientists have replicated an imaging clinical trial using computer methods, suggesting in silico trials hold promise for regulatory evaluation. https://ja.ma/2rdAtre   pic.twitter.com/XiTbPfEkcj
. @US_FDA scientists have replicated an imaging clinical trial using computer methods, suggesting in silico trials hold promise for regulatory evaluation. https://ja.ma/2rdAtre  pic.twitter.com/XiTbPfEkcj (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 1, 2018 Category: Medical Devices Authors: ( at JAMANetworkOpen) Source Type: news

#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA   #MedicalDevice
#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn   #MedicalDevicepic.twitter.com/YU9Iq3Yw0b
. @US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn  #MedicalDevice pic.twitter.com/YU9Iq3Yw0b (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.usa.gov/xPMEK   #MedicalDevicepic.twitter.com/M55ddC98wW
. @US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.usa.gov/xPMEK  #MedicalDevice pic.twitter.com/M55ddC98wW (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk   pic.twitter.com/6rRnfSyLy4
Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk  pic.twitter.com/6rRnfSyLy4 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA has selected 8 novel medical devices as participants in #FDA ’ s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge
. @US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk   #FDA #MedicalDevice
#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We aim to efficiently advance beneficial technology to patients, while solidifying FDA ’ s gold standard for safety. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest demonstrated improvements and advances in safety.
We aim to efficiently advance beneficial technology to patients, while solidifying FDA’s gold standard for safety. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest demonstrated improvements and advances in safety. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devices.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device while promoting greater competition to adopt modern features that improve safety and performance.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We ’ re considering focusing on predicates that are > 10 years old as a starting point, so the public is aware of those technologies.
In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are>10 years old as a starting point, so the public is aware of those technologies. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we ’ re looking at ways to promote the use of more recent predicates
These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we’re looking at ways to promote the use of more recent predicates (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

An infusion pump whose predicate device uses older “ beam break ” technology to estimate the size of the drop. The new device uses a video camera and vision processing to monitor the drop formation and detect drops falling, making the device more precise and more accurate.
An infusion pump whose predicate device uses older “beam break” technology to estimate the size of the drop. The new device uses a video camera and vision processing to monitor the drop formation and detect drops falling, making the device more precise and more accurate. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

An X-ray system that includes a controller to control time of x-ray exposure. These new devices now meet performance standards and consensus standards that were either not available or have been revised to meet more modern criteria since the predicate device was cleared
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

A hemodialysis system, which has modernized through miniaturization; and a patient monitoring system that can monitor more patients and/or more parameters and which are increasingly becoming networked in healthcare facilities increasing the risk for cybersecurity threats.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Following are some examples of devices that have been modernized over the past several years, but for which some manufacturers have relied on older predicates:
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news