FDA MedTech

Big data, cybersecurity among top FDA device center priorities

Released on August 23, 2019

Leveraging big data and real-world evidence in regulatory decisions, enhancing medical device cybersecurity and streamlining clinical trial design are some of the top priorities identified…

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Cardiology FDA

Edwards Lifesciences slides after FDA slaps Class I on Sapien 3 Ultra recall

Released on August 23, 2019

Edwards Lifesciences (NYSE:EW) shares slid today after the FDA slapped Class I status on last month’s recall of its Sapien 3 Ultra…

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Cardiology FDA

FDA grants breakthrough nod to Miracor Medical’s PiCSO device

Released on August 22, 2019

Miracor Medical said today that it received breakthrough designation from the FDA for its PiCSO device for treating a type of…

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FDA Structural Heart

New Expanded Indication Could Change the TAVR Narrative

Released on August 19, 2019

Now Edwards and Medtronic’s transcatheter aortic valve replacement devices can be used in patients with low-risk for death or major complications associated with open-heart surgery…

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FDA MedTech

August Is Hot with New FDA Breakthrough Device Designations

Released on August 18, 2019

V-Wave is joining the growing list of companies that have been granted breakthrough device designation by FDA this month…

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FDA Orthopedic

FDA Approval Recognizes Vertebral Body Tethering as a Mainstream Scoliosis Treatment

Released on August 16, 2019

Called The Tether – Vertebral Body Tethering System, the device is intended to treat growing children and adolescents whose spinal curves are approaching or have reached the range where surgical treatment is an option…

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Cardiology FDA

V-Wave’s Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure

Released on August 15, 2019

V-Wave Ltd., today announced that the U.S. Food and Drug Administration (FDA) has just granted the company a Breakthrough Device Designation for its interatrial shunt for Heart Failure (HF)…

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Cardiology FDA

FDA grants breakthrough nod to Concept Medical for below-the-knee use of MagicTouch DCB

Released on August 14, 2019

Medtech developer Concept Medical said today it won FDA breakthrough device designation for below-the-knee (BTK) use of its MagicTouch sirolimus drug-coated balloon catheter designed for …

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FDA MedTech

FDA slaps Class I label on Fresenius Kabi USA infusion pump recall

Released on August 13, 2019

In June, Fresenius Kabi USA voluntarily began the recall of its Volumat MC Agilia volumetric infusion pump to …

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FDA MedTech

Dalent Medical readying to launch Sinusleeve device

Released on August 13, 2019

Dalent Medical said last week that it has listed its Sinusleeve balloon sinus dilation device with the FDA….

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FDA Vascular

Endologix Takes a Step Forward with Nellix IDE

Released on August 12, 2019

Endologix has received investigational device exemption (IDE) approval from FDA for a new pivotal study to evaluate the safety and effectiveness of the…

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Biotech FDA

FDA wants more study of paclitaxel-eluting devices’ long-term safety

Released on August 9, 2019

The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons…

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