The U.S. FDA has approved the Senza Omnia Spinal Cord Stimulation (SCS) system from Redwood City, Calif.-based Nevro Corp. The system is the first such system that delivers Nevro's high frequency 10,000 Hz stimulation, known as HF10, but also all other therapeutic spinal cord stimulation frequencies.
How much Senate Democrats oppose President Donald Trump's new nominee to take over the reins of the FDA could depend on whom they dislike or distrust more – Stephen Hahn, the nominee, or Brett Giroir, who just became the new acting FDA commissioner.
The new draft guidance for clinical decision support (CDS) software is in part a response to the 21st Century Cures Act, and the FDA Bakul Patel said on a Nov. 4 webinar, "we heard the feedback loud and clear" on the previous draft, and thus the agency must "get this policy to a place where it balances patient safety" and the need to avoid unnecessary roadblocks between developers and the market.
How much Senate Democrats oppose President Donald Trump's new nominee to take over the reins of the FDA could depend on whom they dislike or distrust more – Stephen Hahn, the nominee, or Brett Giroir, who just became the new acting FDA commissioner.
The U.S. FDA's breakthrough devices program continues to rack up new designations, this latest one for Shréis Scalene Sciences LLC's Cytotron device. The noninvasive whole-body system, which is intended to break down or interrupt the growth of malignant tumors, is already CE marked and available in the European Union.
Robotics has been a hot topic over the last year or so, from product unveilings to M&A. Now, Xact Robotics Ltd., which has a presence in Hingham, Mass., and Caesarea, Israel, has reported that its first robotic system gained clearance in the U.S. for use during computed tomography-guided percutaneous interventional procedures.
The FDA's guidance for uncertainty of benefit-risk provided some clarity on the benefit-risk question, but the terms of the "uncertainty" guidance could apply to the agency's Safer Technologies Program (STeP) despite that the STeP program applies to 510(k) devices, which are excluded from the scope of the uncertainty guidance.
Surmodics Inc., of Eden Prairie, Minn., said the U.S. FDA has granted a breakthrough device designation to its Sundance sirolimus-coated balloon (SCB) catheter to potentially help those suffering from critical limb ischemia (CLI) and infrapopliteal arterial disease.
The U.S. FDA has granted a breakthrough device designation for a new hemodialysis system from Fresenius Medical Care Holdings Inc. The device is designed to prevent blood blotting without the use of blood-thinning medication, such as heparin, that most dialysis patients require.
The FDA held a webinar directed toward the recent draft guidance for the accreditation scheme for conformity assessment (ASCA), but while independent labs figure to handle much of the related activity, FDA staff welcomed manufacturer's labs as well, emphasizing that the agency seeks the participation of all potentially interested parties.
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