FDA Archives - Page 4 of 15 - TMG Pulse

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Diagnostics FDA Patient Monitoring

Bodyport receives FDA 510(k) for connected scale

Bodyport announced it has received the FDA green light for its connected scale that remotely monitors […]

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Catheters FDA IDE

MedAlliance wins second FDA IDE nod for drug-coated balloon

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

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FDA IDE Neuro

CereVasc announces US FDA approval for second IDE study of eShunt system

CereVasc announced today that the US Food and Drug Administration (FDA) has approved an investigational […]

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FDA Neuro Robotics

Brain Navi plans to seek US FDA approval for neurosurgical navigation robot

Taiwanese surgical robotic firm Brain Navi Biotechnology plans to submit its autonomous neurosurgical navigation robot, NaoTrac, for […]

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FDA Healthcare MedTech

FDA’s breakthrough device designations poised for another record year

At the midpoint of the year, the FDA had granted 129 designations, suggesting it will […]

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Diabetes FDA Public Offering

Insulet moves to full launch of Omnipod 5

Insulet began full market release of its Omnipod 5 insulin pump, the company announced on Monday. The […]

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FDA Healthcare MedTech

FDA eases UDI compliance requirements for some low-risk medical devices

The US Food and Drug Administration has exempted low-risk medical devices considered consumer health products […]

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CE Mark Diabetes FDA

‘Subtle’ Software Changes Delay Dexcom’s G7 FDA Nod

One of medtech’s most anticipated devices is facing yet another delay in obtaining FDA clearance. […]

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Catheters FDA Imaging

Acutus Has a Wider Reach for 3D Imaging and Mapping Catheter

Acutus Medical said its AcQMap High-Resolution Imaging and Mapping System and the AcQMap 3D Imaging […]

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FDA Spine Surgery

Altus Spine agrees private label partnership with Nanovis Spine

Altus Spine has announced a private label partnership with Nanovis Spine to further strengthen and […]

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FDA Spine Surgery

Waypoint Orthopedics submits FDA 510(k) application for Waypoint GPS system

Waypoint Orthopedics recently announced the submission of a US Food and Drug Administration (FDA) 510(k) […]

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FDA Implantables Surgery

Further three prodisc cervical total disc replacement devices granted FDA approval

Centinel Spine has announced US Food and Drug Administration (FDA) pre-market application (PMA) approval for […]

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FDA Machine Learning Spine

Medtronic receives FDA clearance for next-generation UNiD Spine Analyzer

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

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FDA Imaging Neuro

Hyperfine unveils new software for rapid MR brain imaging

FDA recently cleared a software upgrade to Hyperfine’s portable MRI device that enables scenes in […]

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Cardiology Clinical Trial FDA

Ancora Heart Wins Breakthrough Device Designation

Ancora Heart said FDA has granted Breakthrough Device Designation to the AccuCinch Ventricular Restoration System. […]

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FDA Healthcare Neuro

Abbott Looks to Treat Severe Depression with DBS

Abbott Laboratories has won breakthrough device designation for its deep brain stimulation (DBS) system to […]

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AR/VR Digital Therapeutics FDA

UK startup hopes FDA nod speeds up adoption of VR therapy

A UK startup has secured breakthrough device designation for a prescription-based software product using virtual […]

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Clinical Trial FDA MedTech

Notable Changes in the New FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions

Notable Changes in the new FDA Draft Guidance – Content of Premarket Submissions for Device […]

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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 […]

Topic: FDA

Bodyport receives FDA 510(k) for connected scale

MedAlliance wins second FDA IDE nod for drug-coated balloon

CereVasc announces US FDA approval for second IDE study of eShunt system

Brain Navi plans to seek US FDA approval for neurosurgical navigation robot

FDA’s breakthrough device designations poised for another record year

Insulet moves to full launch of Omnipod 5

FDA eases UDI compliance requirements for some low-risk medical devices

‘Subtle’ Software Changes Delay Dexcom’s G7 FDA Nod

Acutus Has a Wider Reach for 3D Imaging and Mapping Catheter

Altus Spine agrees private label partnership with Nanovis Spine

Waypoint Orthopedics submits FDA 510(k) application for Waypoint GPS system

Further three prodisc cervical total disc replacement devices granted FDA approval

Medtronic receives FDA clearance for next-generation UNiD Spine Analyzer

Hyperfine unveils new software for rapid MR brain imaging

Ancora Heart Wins Breakthrough Device Designation

Abbott Looks to Treat Severe Depression with DBS

UK startup hopes FDA nod speeds up adoption of VR therapy

Notable Changes in the New FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions

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