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Canon Medical’s AI-Powered, Premium Large Bore CT Receives FDA Clearance

Canon Medical Systems USA, Inc. has received FDA clearance for the Aquilion Exceed LB CT system, giving clinicians the opportunity to see more during radiation therapy planning for accuracy, precision and speed.

FDA Clears MULTIX Impact C Ceiling-Mounted DR System

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the MULTIX Impact C ceiling-mounted digital radiography (DR) system as well as the MULTIX Impact VA20, a new version of the established floor-mounted parent DR system.

FDA Approves Seno Medical’s Breast Cancer Diagnostic Technology

The Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments Inc.

Philips to Acquire Capsule Technologies Inc.

Royal Philips has signed an agreement to acquire Capsule Technologies Inc., a provider of medical device integration and data technologies for hospitals and healthcare organizations.

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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