Approvals

CelioFlex Miniprobes Earn CE Mark for Use in Robotic-Assisted Surgery

Mauna Kea Technologies received a CE Mark for its CelioFlex UHD Confocal Miniprobes for use with Cellvizio in robotic-assisted surgery procedures.

The miniprobes provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robotic-assisted procedures.

The company has received clearance to sell a wide range of Cellvizio applications in more than 40 countries, including the United States, Europe, Japan, China, Canada, Brazil and Mexico.

FDA Clears Siemens Healthineers’ Terra 7T MRI Scanner

The FDA has signed off on Siemens Healthineer’s Magnetom Terra magnetic resonance imaging (MRI) scanner for diagnostic imaging.

The scanner is the first 7T MRI system cleared for clinical use in the country. It produces cross-sectional images of the head and knee using Siemens’ software platform as well as image reconstruction technology, allowing speeds up to 20 times more than previous scanners.

Philips Receives 510(k) Clearance for Ultrasound Device

Royal Philips received 510(k) marketing clearance for the eL18-4 transducer for ultrasound exams to detect abnormalities in the small organs close to the skin.

The transducer can be used to assess diseases and disorders of small organs such as breasts, testicles and thyroid, as well as musculoskeletal injuries like sprains.

Neuronetics’ MDD Therapy System Snags Shonin Approval

Neuronetics received Japan’s Shonin approval for a transcranial magnetic stimulation non-drug treatment option for major depressive disorder treatment.

The NeuroStar Advanced Therapy system uses MRI magnetic field pulses to non-invasively stimulate underactive areas of the brain delivering electroconvulsive therapy. It also provides real-time feedback to physicians.

The system is approved for commercial distribution in the U.S. and is CE marked.

Stryker Receives FDA Clearance for Cementless Knee Implant

Stryker’s Joint Replacement division received FDA 510(k) market clearance for its cementless Mako Total Knee with Triathlon Tritanium.

The implant combines the motion features of Stryker’s Triathlon knee implant with a highly porous biologic fixation technology. The device’s tibial baseplate and metal-backed patella components are made using proprietary manufacturing technology.

FDA Expands Use for NuVasive’s Magnetic Limb Device

NuVasive received expanded 510(k) clearance for its magnetic limb lengthening technology.

The PRECICE system was previously approved for femur and tibia limb lengthening. The new indications for use include fracture fixation, pseudoarthrosis and bone transport, which allows for bony tissue to be regenerated.

The implantable platform uses an external remote controller for non-invasive, customizable treatments on long bones using an internal gear system that can be controlled remotely with permanent magnets.

TransEnterix Scores FDA Approval for Robotically-Assisted Surgical Device

The FDA granted 510(k) marketing clearance to TransEnterix Surgical for its robotically-assisted surgical device for facilitating minimally invasive surgery.

The Senhance system enables surgeons to accurately control laparoscopic instruments with three separate robotic arms. Surgeons can also use the system for 3-D visualization of the surgical field.

The system provides force feedback for assessing the stiffness of tissue and eye-tracking for accurately controlling the robotic arms.

Instrumentation Laboratory Receives FDA Clearance for HemosIL Assay

Instrumentation Laboratory received 510(k) clearance for its HemosIL AcuStar assay for detection of antibodies associated with heparin-induced thrombocytopenia (HIT) and HemosIL AcuStar HIT Controls.

The assay is a fully automated, chemiluminescent reagent on a hemostasis testing system for the qualitative detection of platelet factor 4 (PF4)-heparin complex IgG antibodies associated with HIT. The chemiluminescent technology enables high analytical sensitivity and precision.