Category:
FDA
Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex® Scoring Balloon
Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “We remain committed to expanding our portfolio of differentiated products that help physicians deliver improved outcomes for patients with complex coronary artery disease.
Nevro Reports FDA Approval for Expanded Labeling for Senza® Spinal Cord Stimulation System
This approval is specific to Nevro's proprietary 10 kHz Therapy and differentiates Nevro's Senza System as the only SCS system with specific labeling to treat NSRBP patients.
Endomina System, a New Suturing Tool for Use by Gastroenterologists Receives FDA Clearance
“This technology is a very meaningful addition to our armamentarium for performing procedures requiring suturing,” said Dr Ivo Boškoski from Policlinico Gemelli, Rome, Italy.
VUZE Medical Announces U.S. FDA 510(k) Clearance for Its VUZE System
VUZE Medical, a privately held medical technology company aimed at transforming image guidance and verification in minimally invasive spine surgeries, has received 510(k) clearance...
FDA Approves Cochlear Nucleus Implants for Unilateral Hearing Loss/single-sided Deafness
Cochlear implants are already FDA approved for those with moderate to profound bilateral sensorineural hearing loss. With this approval, for the first time Cochlear can expand implantable treatment options for those with UHL/SSD to include cochlear implants.
Lazurite Announces FDA 510(k) Submission for its ArthroFree™ Wireless Camera System
“This FDA submission marks an important milestone in our commitment to bring an advanced wireless surgical camera to market," said Eugene Malinskiy, chief executive officer and co-founder of Lazurite.
FDA Pre-Submission Filed for Cardio inCode-SCORE
Matthew Walls, CEO of GENinCode Plc, said: "Despite the delays driven by the pandemic, the filing of the Cardio inCode FDA Pre-Submission marks the start of the U.S. regulatory approval pathway and ongoing preparation for the launch of Cardio inCode-SCORE later this year.
BD Introduces Smart Connected Robotics to Automate Microbial Identification (BD Kiestra™)
"The BD Kiestra™ IdentifA system transforms the manual workflow into one that is standardized, automated and digitized," said Greg Miziolek, vice president and general manager of the U.S. region for BD Integrated Diagnostic Solutions.
VySpine Announces FDA Clearance of the VySpan PCT System
“The VySpan PCT System is the first of many highly differentiated systems being developed by VySpine,” said Tom McLeer, CEO of VySpine.
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