FDA Archives - Page 15 of 15 - TMG Pulse

article

FDA MedTech

FDA makes final recommendations on vascular device labels

Dive Brief: FDA has released two final guidance documents featuring recommendations about guidewires and other […]

article

Cardiology FDA

MedTech Medtronic nets FDA breakthrough label for aortic aneurysm-sealing stent system

Medtronic received a breakthrough designation from the FDA for its combination stent-graft system designed to […]

article

Cardiology FDA

FDA grants breakthrough nod for Corvia’s interatrial shunt

Corvia Medical said today that it won FDA breakthrough device designation for its interatrial shunt device […]

article

FDA Neuro Urology

Medtronic submits rechargeable sacral neurostimulation device for FDA approval

Medtronic has submitted for FDA approval a new, rechargeable version of its 20-year-old sacral neuromodulation […]

article

FDA

Dexcom wins FDA clearance for G6 Pro CGM

Dexcom (NSDQ:DXCM) said today that it won 510(k) clearance from the FDA for its G6 Pro […]

article

FDA Neuro

Solving Migraines With Unique FDA-Registered Vibration Massage Therapy Device

The BIPRI 8-Motor Headband Is Changing the Game for Chronic Migraine Sufferers. FRANKLIN, Tenn., Oct. 8, […]

article

FDA MedTech

Paclitaxel device makers roll out revised labels, fresh safety analyses

Dive Brief: Months after FDA publicly scrutinized a late mortality signal among patients with peripheral artery disease in the femoropopliteal […]

article

FDA

Third-party software vulnerability could endanger medical devices, FDA and DHS warn

Dive Brief: FDA and the Department of Homeland Security Tuesday issued concurrent advisories alerting patients, […]

article

AI FDA

Bay Labs achieves significant clinical milestone and receives breakthrough device designation; Changes name to Caption Health

Caption Guidance, the company’s transformational ultrasound software, successfully meets primary endpoints in pivotal clinical study […]

article

FDA

FDA plans advisory panel on metal implants, dental alloys

The FDA is slated to hold an advisory panel meeting to discuss immunology concerns about […]

article

FDA Neuro

Abbott nets approval for 'low-dose' long-term neurostimulator

The FDA has approved a new “low-dose” version of Abbott’s spinal cord neurostimulation system, designed […]

article

AI Digital Health FDA

FDA delivers guidance on AI and clinical decision-making

A package of new guidance documents from the FDA describes what and how the agency […]

article

FDA

Device chief says FDA could be open to making breakthrough designations public

BOSTON — FDA may be open to making public which devices the agency awards breakthrough […]

article

FDA Neuro

Aurora Concussion Therapy Systems wins breakthrough nod from FDA

Aurora Concussion Therapy Systems said this week that it won breakthrough device designation from the FDA […]

article

FDA Structural Heart

Medtronic Wins Nod for TAVR System Ahead of TCT 2019

Medtronic has won a nod from FDA for the Evolut PRO+ TAVR System â€“ a […]

article

FDA Imaging Ophthalmology

NESTcc, ophthalmic imaging first up in FDA medical device 'collaborative communities'

Dive Brief: FDA Thursday launched the first two so-called collaborative communities, which aim to bring […]

article

FDA MedTech

BRIEF FDA moves to end need for predicate comparisons in some 510(k)s

Dive Brief: FDA has published four draft guidance documents detailing the performance criteria certain devices will need […]

article

FDA Imaging Ophthalmology

FDA joins ‘collaborative communities’

The FDA said yesterday that it will be participating in two “collaborative communities,” joining the National Evaluation […]

article

FDA

FDA creates agencywide tech modernization roadmap

Dive Brief: FDA has created a Technology Modernization Action Plan to guide development of the infrastructure it […]

article

FDA MedTech

MedTech Synchron kicks off clinical trial for brain-machine interface—without drilling skulls

It was 2012, and research into brain-machine interfaces was stuck. The technology, which links brain […]

article

FDA Vascular

LimFlow wins FDA nod for pDVA trial in chronic limb-threatening ischemia

LimFlow said today that it won an investigational device exemption from the FDA for a pivotal […]

article

FDA Orthopedic

First 'Artificial Meniscus' Wins FDA Breakthrough Device Designation

U.S. patients who continue to suffer from knee pain after meniscus surgery, but are too young […]

article

FDA MedTech

Chronic bronchitis device wins breakthrough designation

Dive Brief: FDA has awarded breakthrough device status to Gala Therapeutics for its minimally invasive […]

article

Biotech Cardiology FDA

Orchestra BioMed wins breakthrough nod for Virtue SEB

Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue […]

article

FDA MedTech

FDA warns closure of Atlanta Sterigenics facility could impact medical device supply

Dive Brief: The temporary closure of an Atlanta contract sterilization facility could potentially impact the […]

article

Cardiology FDA

V-Wave gets 2nd breakthrough designation for interatrial shunt

UPDATE: Sept. 12, 2019: V-Wave said Thursday it’s received a second breakthrough device designation for its in-development implantable interatrial shunt, […]

article

FDA Vascular

Gala Therapeutics Receives FDA Breakthrough Device Designation for the Minimally Invasive RheOx™ System for Chronic Bronchitis

MENLO PARK, Calif., Sept. 16, 2019 /PRNewswire/ — Gala Therapeutics, Inc. (Gala), a developer of medical devices to […]

article

FDA

FDA finalizes 4 guidances to clarify 510(k) pathways

Dive Brief: FDA on Thursday issued four finalized or updated guidance documents key to its […]

article

FDA MedTech

US needs cyber-savvy doctors as connected device use rises, FDA panel says

Thinking about medical device cybersecurity risk is a little like considering a potential airplane crash, […]

article

FDA MedTech

Physicians push FDA to shed light on device comparators

Dive Brief: Physicians have called for FDA to be more transparent about the selection of […]

article

FDA Neuro

Checkpoint Surgical wins breakthrough device designation for nerve regeneration device

Checkpoint Surgical today said it received FDA breakthrough device designation for its brief electrostimulation therapy […]

article

FDA MedTech

FDA looks to define 'triggers' for medical device cybersecurity warnings

Dive Brief: FDA wants to strengthen its protocol for deciding when a medical device cybersecurity […]

article

Cardiology FDA

EBR Systems wins FDA breakthrough nod for Wise CRT wireless pacer

EBR Systems said today that it has received breakthrough device designation from the FDA for its […]

article

FDA MedTech

New FDA de novo guidance emphasizes complete applications

The FDA has released final guidance to clarify exactly what medtech companies need to include […]

article

FDA Vascular

Pulmonary arterial hypertension device wins FDA breakthrough designation

Dive Brief: Tel Aviv-based SoniVie has received FDA’s breakthrough device designation for its treatment for […]

Topic: FDA

FDA makes final recommendations on vascular device labels

MedTech Medtronic nets FDA breakthrough label for aortic aneurysm-sealing stent system

FDA grants breakthrough nod for Corvia’s interatrial shunt

Medtronic submits rechargeable sacral neurostimulation device for FDA approval

Dexcom wins FDA clearance for G6 Pro CGM

Solving Migraines With Unique FDA-Registered Vibration Massage Therapy Device

Paclitaxel device makers roll out revised labels, fresh safety analyses

Third-party software vulnerability could endanger medical devices, FDA and DHS warn

Bay Labs achieves significant clinical milestone and receives breakthrough device designation; Changes name to Caption Health

FDA plans advisory panel on metal implants, dental alloys

Abbott nets approval for 'low-dose' long-term neurostimulator

FDA delivers guidance on AI and clinical decision-making

Device chief says FDA could be open to making breakthrough designations public

Aurora Concussion Therapy Systems wins breakthrough nod from FDA

Medtronic Wins Nod for TAVR System Ahead of TCT 2019

NESTcc, ophthalmic imaging first up in FDA medical device 'collaborative communities'

BRIEF FDA moves to end need for predicate comparisons in some 510(k)s

FDA joins ‘collaborative communities’

FDA creates agencywide tech modernization roadmap

MedTech Synchron kicks off clinical trial for brain-machine interface—without drilling skulls

LimFlow wins FDA nod for pDVA trial in chronic limb-threatening ischemia

First 'Artificial Meniscus' Wins FDA Breakthrough Device Designation

Chronic bronchitis device wins breakthrough designation

Orchestra BioMed wins breakthrough nod for Virtue SEB

FDA warns closure of Atlanta Sterigenics facility could impact medical device supply

V-Wave gets 2nd breakthrough designation for interatrial shunt

Gala Therapeutics Receives FDA Breakthrough Device Designation for the Minimally Invasive RheOx™ System for Chronic Bronchitis

FDA finalizes 4 guidances to clarify 510(k) pathways

US needs cyber-savvy doctors as connected device use rises, FDA panel says

Physicians push FDA to shed light on device comparators

Checkpoint Surgical wins breakthrough device designation for nerve regeneration device

FDA looks to define 'triggers' for medical device cybersecurity warnings

EBR Systems wins FDA breakthrough nod for Wise CRT wireless pacer

New FDA de novo guidance emphasizes complete applications

Pulmonary arterial hypertension device wins FDA breakthrough designation