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Siemens Healthineers to Acquire Varian

Siemens Healthineers AG and Varian Medical Systems Inc. have entered into an agreement, pursuant to which Siemens Healthineers shall acquire all shares of Varian for $177.50 per share in cash. This corresponds to a purchase price of approximately $16.4 billion....

MTMI Partners with Nautilus Medical Technologies

The Medical Technology Management Institute (MTMI), a division of The College of Health Care Professions, has announced a partnership with Nautilus Medical Technologies, developer of a cloud-based imaging sharing platform used by over a thousand health care providers...

Gillette Children’s Specialty Healthcare is the first U.S. hospital to image patients with EOSedge

EOS imaging, a provider of 2D/3D orthopedic medical imaging and software solutions for 3D anatomical modeling and surgical planning, has announced the first exams performed with EOSedge in the United States, at Gillette Children's Specialty Healthcare’s main campus...

Webinar on FDA’s Regulation of Face Masks and Surgical Masks during the COVID-19 Pandemic

On Tuesday, August 4, 12:00 p.m.-1:00 p.m. ET, the U.S. Food and Drug Administration (FDA) will host a webinar on the FDA’s regulation of face masks and surgical masks during the COVID-19 pandemic. This webinar will expand the scope of the respirator webinar series to...

Axonics Receives FDA Approval for 3T Full-Body MRI Scans

Axonics Modulation Technologies Inc., a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has received U.S. Food & Drug Administration (FDA) approval under a premarket approval supplement for 3T full-body magnetic resonance imaging (MRI) conditional labeling for the Axonics r-SNM System.
In September 2019, the FDA approved the Axonics r-SNM System with full-body conditional labeling for 1.5T MRI scanners. With this incremental approval for 3T scans, the Axonics device continues to be the only SNM system available in the United States that is MRI compatible for both 1.5T and 3T full-body scans.

Raymond W. Cohen, CEO of Axonics, commented, “This FDA approval allows Axonics to provide health care professionals with more choices in selecting the optimal MR scanner for their patients’ imaging needs. The 3T MRI approval came several months earlier than expected and follows a number of recent FDA approvals, including our new wireless patient remote control with SmartMRI technology and our next generation implantable neurostimulator that extends the interval between recharging to once per month.”

Cohen continued, “These approvals underscore Axonics’ commitment to providing best-in-class SNM solutions for patients, clinicians and the health care system. Since the introduction of the Axonics r-SNM System in late 2019, implanting physicians are telling us that more of their patients are saying ‘yes’ to SNM therapy than ever before. We expect SNM to become the preferred therapy for patients suffering from overactive bladder and bowel dysfunction and we remain confident that our keen focus on innovation and increasing patient awareness will significantly expand the SNM market in the years ahead.”

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