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.
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.
“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, a privately held medical technology company aimed at transforming image guidance and verification in minimally invasive spine surgeries, has received 510(k) clearance...
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.
“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.
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.
"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.