Fdanewsdevicedailybulletin

June 25, 2018

Vol. 15 No. 122

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Medtronic Gains Expanded Indication for Bone Cement

The bone cement’s expanded indication now allows it to treat fractures caused by osteoporosis, cancer or benign lesions by using a cementoplasty procedure. Read More

LumiThera’s Dry AMD Treatment Device Gains CE Mark

The treatment incorporates low level light therapy, applying red and near-infrared light to improve and repair tissue. Read More

Bayer’s Essure Device Permanently Withdrawn From the EU

Women implanted with the device may continue to use the device, and preventive removal is not necessary for women not presenting any symptoms, FAMHP said. Read More

FDA Suggests Alternatives for Complying With QS Requirements

The combination product can be exempted from certain device QS requirements if the device constituent is exempt from such requirements. Read More