FDA Neuro

Intrasaccular aneurysm treatment device receives US FDA PMA approval

Released on January 7, 2020

MicroVention, a US-based subsidiary of Terumo and a global neurovascular company, announces the US FDA premarket approval (PMA) for the WEB […]

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FDA

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

Released on January 6, 2020

Some in the device industry are pushing back against proposed FDA label changes to breast implants, including an acknowledgement of “breast […]

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FDA

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

Released on January 5, 2020

Avita Medical (ASX:AVH) said it received FDA investigational device exemption approval for a study to evaluate its Recell System for vitiligo. The […]

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FDA Neuro

FDA reduces controls on electrical stimulation devices for anxiety, insomnia

Released on January 2, 2020

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

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FDA

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

Released on December 30, 2019

The FDA today published a list of Class I and Class II medical devices that it now considers exempt from premarket […]

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Drug-delivery FDA

FDA wants feedback on combination products guidance

Released on December 27, 2019

The FDA is seeking comment from sponsors of combination products on how they want the agency to respond to their scientific […]

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Cardiology FDA

Report: FDA has nonpublic list of TAVR-related deaths

Released on December 27, 2019

The FDA has yet another private listing of device-related deaths, this one for transcatheter aortic valve replacement (TAVR) devices that include Medtronic’s (NYSE:MDT)  […]

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Drug-delivery FDA

FDA creates best practices for combination product developers

Released on December 24, 2019

Dive Brief: FDA is seeking feedback on how it communicates with developers of combination products. In draft guidance published Monday, FDA […]

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FDA Spine

Life Spine wins FDA nod for titanium spine fusion spacer system

Released on December 23, 2019

Life Spine announced today that it won FDA 510(k) clearance for its titanium stand-alone anterior lumbar interbody fusion (ALIF) spacer system. […]

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FDA Neuro

LivaNova recalls vagus nerve implant amid reset problems

Released on December 23, 2019

Dive Brief: LivaNova is recalling its vagus nerve stimulation (VNS) device that is implanted in patients to treat major depressive episodes […]

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Cardiology FDA

Adagio Medical starts iCLAS AFib trial

Released on December 19, 2019

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

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FDA MedTech

FDA may change how it announces PMA, HDE decisions

Released on December 17, 2019

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

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