Cardiology FDA Approved Surgery

Abbott’s Gallant Heart Rhythm Implants FDA Approved

Released on July 6, 2020

Abbott won FDA approval for its Gallant implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator devices. Cleared in Europe earlier this […]

Read more
FDA Approved Implantables Urology

Axonics receives FDA approval for 3T full-body MRI scans

Released on July 2, 2020

Axonics, a company that has developed and is commercialising novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and […]

Read more
Cardiology FDA Approved MedTech

Philips Gets FDA Approval for Two New Defibrillators

Released on June 30, 2020

Philips won FDA approval for its HeartStart FR3 and HeartStart FRx automated external defibrillators (AEDs). The HeartStart FR3 is an advanced […]

Read more
FDA Approved MedTech Neuro

FDA approves Percept PC neurostimulator with BrainSense technology

Released on June 25, 2020

Medtronic has announced it received US Food and Drug Administration (FDA) approval for the Percept PC deep brain stimulation (DBS) system. […]

Read more
Digital Health FDA Approved MedTech

Move to digital mammography failed to improve outcomes, study finds

Released on June 25, 2020

Dive Brief: A meta-analysis of 24 studies has found the move from film to digital mammography failed to deliver the hoped-for […]

Read more
FDA Approved Implantables Neuro

Medtronic’s brain-reading stimulator nets FDA approval

Released on June 25, 2020

The FDA has approved Medtronic’s latest deep-brain stimulation implant, featuring the ability to read, capture and transmit a patient’s brain signals […]

Read more
Cardiology FDA Approved MedTech

Philips wins FDA approval for new automated external defibrillators

Released on June 24, 2020

Royal Philips (NYSE:PHG) announced today that FDA has granted premarket approval for the company’s HeartStart FR3 and HeartStart FRx automated external defibrillators. […]

Read more
FDA Approved Implantables Neuro

Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain

Released on June 22, 2020

June 22, 2020 06:00 UTC U.S. commercialization expected to begin in the first half of 2021 Continues positive momentum for Mainstay, […]

Read more
FDA Approved Implantables Neuro

FDA approval for Axonics’ wireless patient Remote Control with SmartMRI technology

Released on June 4, 2020

Axonics, a company that has developed implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has announced […]

Read more
FDA Approved Orthopedic Spine

Centinel Spine announces approval for the manufacturing transfer of prodisc technology

Released on May 28, 2020

Centinel Spine has announced US Food and Drug Administration (FDA) approval for the manufacturing transfer of both the prodisc C Cervical […]

Read more
Cardiology FDA Approved MedTech

CardioFocus Announces US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation

Released on May 12, 2020

MARLBOROUGH, Mass., May 12, 2020 /PRNewswire/ — CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the next-generation HeartLight® X3 Endoscopic […]

Read more
FDA Approved Healthcare Oncology

Novocure posts data from post-approval brain cancer device trial

Released on April 28, 2020

Dive Brief: Oncology medtech Novocure presented data Monday from a non-inferiority study run to meet a requirement mandated as part of […]

Read more