FDA Archives - TMG Pulse

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Cardiology FDA MedTech

Roundup: CardieX files 510(k) for dual blood pressure, arterial health monitor and more briefs

CardieX files 510(k) for dual blood pressure, arterial health monitor Australia-listed health tech firm CardieX […]

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FDA IDE Radiology

Varian wins FDA IDE for Flash radiation therapy

Varian announced today that it received FDA investigational device exemption IDE to advance its Flash clinical […]

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FDA MedTech Oncology

FDA opens consultation on tissue removal devices to reduce cancer risk

Dive Brief: The Food and Drug Administration is seeking feedback on draft guidance intended to help manufacturers […]

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AI FDA Machine Learning

US FDA finalizes guidance on machine learning for medical devices

The US Food and Drug Administration has finalized guidance on the regulation of software as […]

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Clinical Trial FDA Implantables

3Spine granted investigational device exemption approval

3Spine has announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for […]

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Clinical Trial FDA Pediatrics

How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms

SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyper […]

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Clinical Trial FDA Neuro

Carthera receives FDA Breakthrough Device designation for Sonocloud-9 system

Carthera announced today that its Sonocloud-9 system has been listed as a Breakthrough Device by […]

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FDA Ophthalmology Wearables

J&J Develops Contacts to Address Digital Eye Strain

One of the most common forms of eye strain now comes from looking at the […]

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FDA Patient Monitoring Wearables

Apple Watch App Cleared for Parkinson’s Monitoring

Aura Oslapas says that being able to show her neurologist how her motor symptoms were […]

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FDA Spine Surgery

Aurora Spine receives FDA 510(k) clearance for its DEXA SOLO-L ALIF device

Aurora Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) […]

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FDA Implantables Orthopedic

FDA clears lumbar interbody fusion device from Zavation Medical

Zavation Medical announced today that it received FDA 510(k) clearance for its eZspand lateral expandable lumbar […]

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FDA Healthcare MedTech

House passes FDA user-fee package, bolstering cybersecurity, clinical trial diversity for medical devices

Dive Brief: The House of Representatives passed legislation late Wednesday to reauthorize the Food and […]

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FDA Healthcare MedTech

US FDA withdraws COVID-era guidance for medical device and IVD market approval processes

The US Food and Drug Administration announced that it has withdrawn its temporary policies related […]

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FDA MedTech Women's Health

FDA to start accepting all pre-submissions for in vitro diagnostics

Dive Brief: The Food and Drug Administration’s Center for Devices and Radiological Health plans to […]

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AI Cardiology FDA

Mayo Clinic, Janssen AI to detect pulmonary hypertension scores FDA breakthrough nod

Though it affects only somewhere between 0.1% and 1% of the world’s population, pulmonary hypertension […]

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Drug-delivery FDA IDE

FDA grants IDE for MedAlliance’s sirolimus-eluting balloon

MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR […]

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Clinical Trial FDA Neuro

Neuromodulation for post-stroke recovery advancing on several fronts

As a principal investigator for the pivotal VNS-REHAB study, which supported the first US Food […]

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AI FDA Robotics

What FDA’s New Machine Learning Guiding Principles Really Mean

Machine Learning has been an ongoing focus of FDA activity for some time. The first […]

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Clinical Trial Digital Therapeutics FDA

100% Survival in Clinical Test Puts Rocket Pharma Gene Therapy on Course to FDA

The serious and life-threatening infections experienced by those born with the rare immune disorder leukocyte […]

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FDA Funding MedTech

ApiJect picks up $111M investment from Royalty Pharma, Jefferies

Injection delivery system developer ApiJect announced today that it completed a private investment round worth […]

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Drug-delivery FDA MedTech

FDA approves IND for Ananda Scientific’s PTSD treatment with liquid structure delivery tech

Ananda Scientific announced that it received an FDA investigational new drug (IND) approval for a […]

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FDA Neuro Wearables

FDA approves launch of “largest clinical trial to date” for tDCS depression treatment

Flow Neuroscience, which claims to be the creator of Europe’s first medically approved brain stimulation […]

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Diagnostics FDA MedTech

Cepheid secures FDA EUA for rapid Covid-19 diagnostic test

Cepheid has announced that its Xpert Xpress CoV-2 plus test has received emergency use authorisation (EUA) from […]

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FDA Healthcare MedTech

FDA Drafts Guidance on Medical Device Voluntary Improvement Program

The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation […]

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FDA Implantables Neuro

Synchron enrolls first patient in US COMMAND study of endovascular brain-computer interface

Synchron has announced the enrollment of the first patient in the US COMMAND clinical trial […]

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Drug-delivery FDA MedTech

FDA warns of potential toxic risk from Fresenius hemodialysis machines

The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used […]

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FDA Spine Surgery

Data show superiority of Simplify cervical disc compared to ACDF for the treatment of two-level cervical spondylosis

Results from a two-level multicentre FDA investigational device exemption (IDE) study have shown superior outcomes […]

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FDA Healthcare MedTech

FDA may order Philips to resolve respiratory devices recall

The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory […]

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FDA MedTech Spine

Empirical Spine submits PMA Module II for LimiFlex Dynamic Sagittal Tether

Empirical Spine recently submitted premarket approval (PMA) Module II in the US Food and Drug […]

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FDA Pain Management Wearables

Ear-puffing device for migraine treatment wins FDA breakthrough designation

A handheld device that treats migraine attacks with puffs of air in a patient’s ears […]

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Cardiology FDA Implantables

Medtronic investigates HVAD pump welds after patient deaths

Medtronic (NYSE:MDT) is investigating a new problem with its HeartWare Ventricular Assist Device (HVAD) nearly one […]

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Contract Manufacturing FDA MedTech

MITA: The Time is Right for Clarity on Device Remanufacture

The medical imaging device group, MITA, has voiced support for legislation that calls for clarity […]

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FDA MedTech Neuro

Another setback for Axsome, as migraine med expected to get a no from FDA

Axsome Therapeutics is bracing for another setback as the FDA is now expected to nix […]

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FDA Healthcare MedTech

US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions

On April 8, 2022, the US Food and Drug Administration published a new draft guidance, […]

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FDA Implantables Spine

NuVasive announces positive data for its Simplify cervical disc

NuVasive (Nasdaq:NUVA) today announced data from an FDA investigational device exemption study supporting its Simplify cervical […]

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Cardiology FDA Vascular

Philips says CavaClear used successfully for IVC filter removal

Royal Philips (NYSE:PHG) announced today that the first patients were successfully treated with its CavaClear IVC […]

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FDA Robotics Surgery

FDA approves IDE supplement for Virtual Incision’s miniaturized surgical robotics platform

Virtual Incision announced today that it received an FDA investigational device exemption (IDE) supplement for its […]

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Diagnostics FDA MedTech

FDA authorizes first COVID-19 breathalyzer test, clearing path to 3-minute results

After researchers began looking into ways to detect COVID-19 in breath samples, InspectIR Systems’ test will […]

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FDA MedTech

FDA can’t explain record-low medical device recalls

Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according […]

Topic: FDA

Roundup: CardieX files 510(k) for dual blood pressure, arterial health monitor and more briefs

Varian wins FDA IDE for Flash radiation therapy

FDA opens consultation on tissue removal devices to reduce cancer risk

US FDA finalizes guidance on machine learning for medical devices

3Spine granted investigational device exemption approval

How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms

Carthera receives FDA Breakthrough Device designation for Sonocloud-9 system

J&J Develops Contacts to Address Digital Eye Strain

Apple Watch App Cleared for Parkinson’s Monitoring

Aurora Spine receives FDA 510(k) clearance for its DEXA SOLO-L ALIF device

FDA clears lumbar interbody fusion device from Zavation Medical

House passes FDA user-fee package, bolstering cybersecurity, clinical trial diversity for medical devices

US FDA withdraws COVID-era guidance for medical device and IVD market approval processes

FDA to start accepting all pre-submissions for in vitro diagnostics

Mayo Clinic, Janssen AI to detect pulmonary hypertension scores FDA breakthrough nod

FDA grants IDE for MedAlliance’s sirolimus-eluting balloon

Neuromodulation for post-stroke recovery advancing on several fronts

What FDA’s New Machine Learning Guiding Principles Really Mean

100% Survival in Clinical Test Puts Rocket Pharma Gene Therapy on Course to FDA

ApiJect picks up $111M investment from Royalty Pharma, Jefferies

FDA approves IND for Ananda Scientific’s PTSD treatment with liquid structure delivery tech

FDA approves launch of “largest clinical trial to date” for tDCS depression treatment

Cepheid secures FDA EUA for rapid Covid-19 diagnostic test

FDA Drafts Guidance on Medical Device Voluntary Improvement Program

Synchron enrolls first patient in US COMMAND study of endovascular brain-computer interface

FDA warns of potential toxic risk from Fresenius hemodialysis machines

Data show superiority of Simplify cervical disc compared to ACDF for the treatment of two-level cervical spondylosis

FDA may order Philips to resolve respiratory devices recall

Empirical Spine submits PMA Module II for LimiFlex Dynamic Sagittal Tether

Ear-puffing device for migraine treatment wins FDA breakthrough designation

Medtronic investigates HVAD pump welds after patient deaths

MITA: The Time is Right for Clarity on Device Remanufacture

Another setback for Axsome, as migraine med expected to get a no from FDA

US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions

NuVasive announces positive data for its Simplify cervical disc

Philips says CavaClear used successfully for IVC filter removal

FDA approves IDE supplement for Virtual Incision’s miniaturized surgical robotics platform

FDA authorizes first COVID-19 breathalyzer test, clearing path to 3-minute results

FDA can’t explain record-low medical device recalls