Cardiology FDA Structural Heart

Teleflex wins FDA clearance for Wattson temporary pacing guidewire

Released on January 23, 2020

Teleflex (NYSE:TFX) announced today that it won FDA 510(k) clearance for its Wattson temporary pacing guidewire for use during transcatheter aortic valve […]

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FDA Vascular

Ra Medical Systems wins FDA’s OK to study new uses for Dabra system

Released on January 22, 2020

Ra Medical Systems (NYSE:RMED) announced today that it won investigational device exemption approval to study use of its Dabra excimer laser system […]

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FDA MedTech

5 medtech trends to track in 2020

Released on January 17, 2020

The medtech industry entered 2020 celebrating the medical device tax’s permanent repeal, a levy it spent the better part of a […]

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Augmented Reality FDA Virtual Reality

Virtual, augmented reality in medicine pique FDA’s interest

Released on January 17, 2020

Dive Brief: FDA announced Thursday it will host a meeting March 5 to discuss virtual and augmented reality in medicine. The […]

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Cardiology FDA

Neovasc Reducer gains FDA PMA review

Released on January 16, 2020

Neovasc this week said it received FDA premarket approval for its Reducer device. Reducer is designed to treat refractory angina, which […]

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FDA Oncology

ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations

Released on January 15, 2020

Dive Brief: The latest flurry of breakthrough device designation announcements positions​ ArcherDX, Geneoscopy and Phagenesis to benefit from regulatory perks. The companies […]

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FDA

FDA guidance on catheters zeros in on testing, coatings

Released on January 13, 2020

Dive Brief: FDA on Friday released a draft guidance document with recommendations that focus in large part on bench testing and […]

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FDA Women's Health

Enrollment has ended in Essure postmarket study, FDA says

Released on January 13, 2020

Dive Brief: FDA on Friday announced that enrollment in a postmarket study of the discontinued Essure permanent birth control implant has […]

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Cardiology FDA

Reflow Medical wins FDA breakthrough nod for Temporary Spur Stent System

Released on January 10, 2020

Reflow Medical announced yesterday that its Temporary Spur Stent system for treating below-the-knee peripheral artery disease (PAD) won FDA breakthrough device designation. […]

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Drug-delivery FDA

7 medtech advances to improve diabetes treatment

Released on January 10, 2020

Medtech and pharmaceutical companies have made several important strides over the past year when it comes to improving diabetes treatment. Multiple […]

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FDA MedTech

Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound

Released on January 10, 2020

FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but may be set to rebound upward […]

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Digital Health FDA

US FDA clears NuvoAir’s connected spirometer device

Released on January 9, 2020

Respiratory monitor maker NuvoAir (formerly Pond Healthcare Innovation) has picked up its first FDA 510(k) for Air Next, a portable and […]

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