FDA Archives - Page 13 of 15 - TMG Pulse

article

FDA Neuro

Intrasaccular aneurysm treatment device receives US FDA PMA approval

MicroVention, a US-based subsidiary of Terumo and a global neurovascular company, announces the US FDA […]

article

FDA

Industry, doctors, patients diverge on FDA outline for breast implant labels

Some in the device industry are pushing back against proposed FDA label changes to breast […]

article

FDA

Avita Medical wins FDA investigational device exemption approval for Recell System for vitiligo

Avita Medical (ASX:AVH) said it received FDA investigational device exemption approval for a study to evaluate […]

article

FDA Neuro

FDA reduces controls on electrical stimulation devices for anxiety, insomnia

The FDA recently downgraded the cranial electrical stimulator (CES) devices designed to treat anxiety and […]

article

FDA

FDA publishes final list of 510(k)-exempt devices

The FDA today published a list of Class I and Class II medical devices that […]

article

Drug-delivery FDA

FDA wants feedback on combination products guidance

The FDA is seeking comment from sponsors of combination products on how they want the […]

article

Cardiology FDA

Report: FDA has nonpublic list of TAVR-related deaths

The FDA has yet another private listing of device-related deaths, this one for transcatheter aortic […]

article

Drug-delivery FDA

FDA creates best practices for combination product developers

Dive Brief: FDA is seeking feedback on how it communicates with developers of combination products. […]

article

FDA Spine

Life Spine wins FDA nod for titanium spine fusion spacer system

Life Spine announced today that it won FDA 510(k) clearance for its titanium stand-alone anterior […]

article

FDA Neuro

LivaNova recalls vagus nerve implant amid reset problems

Dive Brief: LivaNova is recalling its vagus nerve stimulation (VNS) device that is implanted in […]

article

FDA Neuro

Axonics granted six US patents and allowed three additional patents related to its implantable Sacral Neuromodulation technology

Axonics has announced that the United States Patent and Trademark Office has issued or allowed […]

article

Cardiology FDA

Adagio Medical starts iCLAS AFib trial

Adagio Medical announced that it enrolled the first patient in its iCLAS investigational device exemption clinical […]

article

FDA MedTech

FDA may change how it announces PMA, HDE decisions

Dive Brief: FDA has taken a step toward ending its practice of publishing a list […]

article

FDA Imaging

Elekta wins FDA approval for diffusion-weighted images

Elekta (STO:EKTA B) today announced that it received FDA 510(k) premarket notification for its diffusion-weighted MR […]

article

Drug-delivery FDA

Tandem wins FDA go-ahead for 1st interoperable, automated insulin dosing software

Dive Brief: FDA on Friday authorized the third and final type of diabetes management technology […]

article

FDA Radiology

FDA qualifies tool for assessing safety of implanted devices

Dive Brief: FDA qualified a tool designed to make it easier for developers of active […]

article

FDA

It's Official, Hahn Will Lead FDA

FDA officially has a new boss. The U.S. Senate voted 72-18 on Thursday to confirm Stephen […]

article

Drug-delivery FDA

Beta Bionics’ bionic pancreas wins breakthrough status from FDA

The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system. The designation […]

article

FDA

Grassley, Warren press FDA to issue over-the-counter hearing aid regulations

Dive Brief: Two powerful Senate lawmakers who helped author the Over-the-Counter Hearing Aid Act pressed […]

article

FDA MedTech

FDA proposes alternative 510(k) criteria for MRI coils

Dive Brief: FDA on Friday issued a draft guidance document outlining the performance criteria that […]

article

FDA MedTech

House bill would speed CMS coverage for breakthrough medtech

Dive Brief: A bipartisan bill reintroduced in the U.S. House on Friday would pave the […]

article

FDA MedTech

Regulatory Development of the Year: 510(k) changes inch along

After a decade serving at the head of FDA’s Center for Devices and Radiological Health, […]

article

Drug-delivery FDA

FDA grades new Medtronic SynchroMed II recall as Class I event

Dive Brief: FDA categorized a Medtronic voluntary recall of certain SynchroMed II implantable drug infusion […]

article

Cardiology FDA

Boston Scientific afib device effective in reducing stroke: JACC

Dive Brief: Two long-term studies of FDA-mandated registries have linked Boston Scientific’s left atrial appendage […]

article

FDA Robotics Surgery

Vicarious Surgical Announces Breakthrough Designation by the FDA, Appoints Scott Huennekens to Board of Directors

First surgical robot to be granted Breakthrough Device classification BOSTON, Dec. 4, 2019 /PRNewswire/ — Vicarious Surgical […]

article

FDA Neuro Ophthalmology

FDA grants breakthrough status to eye-tracking Parkinson's test

Dive Brief: Bethesda, Maryland-based eye-tracking technology developer RightEye received FDA’s breakthrough device for its test for […]

article

Cardiology FDA

FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted

The survival rate of right-heart failure patients treated with the Abiomed (NSDQ:ABMD) Impella RP heart pump remained […]

article

FDA Neuro Ophthalmology

RightEye Has “Breakthrough” in Its Vision for Parkinson’s Test

There could soon be an eye test to aid in the assessment of Parkinson’s disease. […]

article

FDA MedTech

FDA seeks public input on pediatric device applications including ways to minimize burden

Dive Brief: FDA is seeking comments from the public on information required for submitting medical […]

article

FDA Women's Health

Report: More women harmed by medical devices than men

This article has been updated with comments from the FDA and from Madris Tomes. A […]

article

Cardiology FDA

Medtech in a Minute: LivaNova Nixes TMVR, FDA Tackles EtO, and More

FDA Wants Medtech to Cut Back on EtO Use FDA is encouraging manufacturers to reduce […]

article

Digital Health FDA Urology

Renovia Receives FDA OK for Next Generation Pelvic Digital Therapeutic

Renovia has received a nod from FDA for a next-generation pelvic digital therapeutic. The Boston-based […]

article

FDA Spine

FDA clears Life Spine Longbow titanium lateral expandable spacer system

Life Spine announced that it won FDA 510(k) clearance for its Longbow titanium lateral expendable spacer […]

article

Cardiology FDA

Attune Pushing for New Label Indication

Attune Medical is hoping to get a label expansion for its device to reduce thermal […]

article

Drug-delivery FDA

Medtronic warns patients of MiniMed insulin pump safety issue

Medtronic (NYSE:MDT) is warning patients who use its MiniMed 600 series insulin pumps of an issue […]

article

FDA Neuro

Axonics inks deal to supply SNM system to University of Tennessee Medical Center

Axonics Modulation Technologies (NSDQ:AXNX) announced today that it entered into an agreement to supply its r-SNM […]

article

FDA Vascular

FDA grants breakthrough status to Merit's stent graft system

Dive Brief: Merit Medical Systems has received FDA breakthrough designation for its endovascular stent graft […]

article

Cardiology FDA

Transcatheter device to treat heart failure gets breakthrough tag

Dive Brief: FDA granted breakthrough device designation to BioVentrix’s heart failure technology, the company said […]

article

Cardiology FDA

Getinge shares drop on news of more deaths, injuries linked to faulty IABPs

Shares of Getinge (STO:GETI-B) dropped 5% today on news that the FDA had received 60 […]

Topic: FDA

Intrasaccular aneurysm treatment device receives US FDA PMA approval

Industry, doctors, patients diverge on FDA outline for breast implant labels

Avita Medical wins FDA investigational device exemption approval for Recell System for vitiligo

FDA reduces controls on electrical stimulation devices for anxiety, insomnia

FDA publishes final list of 510(k)-exempt devices

FDA wants feedback on combination products guidance

Report: FDA has nonpublic list of TAVR-related deaths

FDA creates best practices for combination product developers

Life Spine wins FDA nod for titanium spine fusion spacer system

LivaNova recalls vagus nerve implant amid reset problems

Axonics granted six US patents and allowed three additional patents related to its implantable Sacral Neuromodulation technology

Adagio Medical starts iCLAS AFib trial

FDA may change how it announces PMA, HDE decisions

Elekta wins FDA approval for diffusion-weighted images

Tandem wins FDA go-ahead for 1st interoperable, automated insulin dosing software

FDA qualifies tool for assessing safety of implanted devices

It's Official, Hahn Will Lead FDA

Beta Bionics’ bionic pancreas wins breakthrough status from FDA

Grassley, Warren press FDA to issue over-the-counter hearing aid regulations

FDA proposes alternative 510(k) criteria for MRI coils

House bill would speed CMS coverage for breakthrough medtech

Regulatory Development of the Year: 510(k) changes inch along

FDA grades new Medtronic SynchroMed II recall as Class I event

Boston Scientific afib device effective in reducing stroke: JACC

Vicarious Surgical Announces Breakthrough Designation by the FDA, Appoints Scott Huennekens to Board of Directors

FDA grants breakthrough status to eye-tracking Parkinson's test

FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted

RightEye Has “Breakthrough” in Its Vision for Parkinson’s Test

FDA seeks public input on pediatric device applications including ways to minimize burden

Report: More women harmed by medical devices than men

Medtech in a Minute: LivaNova Nixes TMVR, FDA Tackles EtO, and More

Renovia Receives FDA OK for Next Generation Pelvic Digital Therapeutic

FDA clears Life Spine Longbow titanium lateral expandable spacer system

Attune Pushing for New Label Indication

Medtronic warns patients of MiniMed insulin pump safety issue

Axonics inks deal to supply SNM system to University of Tennessee Medical Center

FDA grants breakthrough status to Merit's stent graft system

Transcatheter device to treat heart failure gets breakthrough tag

Getinge shares drop on news of more deaths, injuries linked to faulty IABPs