FDA MedTech

Intarcia Therapeutics takes another run at FDA approval

Released on October 16, 2019

Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type […]

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Biotech Diagnostics FDA

Ancestry takes on 23andMe, rolls out genetic health test services

Released on October 15, 2019

Dive Brief: Ancestry announced Tuesday it’s getting into the genetic health testing space with the launch of a two-tiered AncestryHealth platform […]

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FDA Structural Heart

Medtronic Launches Evolut Pro+ TAVR System: Interview with Dr. Pieter Kappetein

Released on October 15, 2019

Last month, Medtronic announced receipt of U.S. Food and Drug Administration (FDA) approval for and launch of the Evolut Pro+ TAVR […]

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FDA Vascular

New FDA guidance out for vascular device labels

Released on October 11, 2019

The FDA has issued two new final guidance documents governing labels for a variety of intravascular devices. One covers labels for intravascular catheters, […]

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FDA MedTech

FDA makes final recommendations on vascular device labels

Released on October 10, 2019

Dive Brief: FDA has released two final guidance documents featuring recommendations about guidewires and other devices used in vascular procedures. One document addresses […]

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Cardiology FDA

Edwards-backed Corvia gets leg up with FDA breakthrough nod

Released on October 10, 2019

Dive Brief: Corvia Medical received FDA’s breakthrough device designation for its interatrial shunt device for heart failure, the company disclosed Wednesday. It describes […]

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Cardiology FDA

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

Released on October 10, 2019

Medtronic received a breakthrough designation from the FDA for its combination stent-graft system designed to seal off large aortic aneurysms that […]

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Cardiology FDA

FDA grants breakthrough nod for Corvia’s interatrial shunt

Released on October 10, 2019

Corvia Medical said today that it won FDA breakthrough device designation for its interatrial shunt device for heart failure. The Tewksbury, Mass.-based […]

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FDA Neuro Urology

Medtronic submits rechargeable sacral neurostimulation device for FDA approval

Released on October 9, 2019

Medtronic has submitted for FDA approval a new, rechargeable version of its 20-year-old sacral neuromodulation implant, designed to treat bowel dysfunction, […]

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FDA

Dexcom wins FDA clearance for G6 Pro CGM

Released on October 8, 2019

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

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FDA Neuro

Solving Migraines With Unique FDA-Registered Vibration Massage Therapy Device

Released on October 8, 2019

The BIPRI 8-Motor Headband Is Changing the Game for Chronic Migraine Sufferers. FRANKLIN, Tenn., Oct. 8, 2019 /PRNewswire/ — Conservative estimates suggest some […]

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FDA MedTech

Paclitaxel device makers roll out revised labels, fresh safety analyses

Released on October 4, 2019

Dive Brief: Months after FDA publicly scrutinized a late mortality signal among patients with peripheral artery disease in the femoropopliteal artery​ who received paclitaxel-administering devices, manufacturers […]

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