Approvals
Philips’ Ventilator System Gains CE Mark
Philips received CE Mark approval for its V60 Plus ventilator system, used for early interventions into respiratory failure.
The system features both noninvasive ventilation and high flow therapy, which allows it to be used with changing patient conditions without having to switch devices.
The device allows for quick therapy and interface transitions and lessens the time physicians need to use for equipment set up.
Implanet Receives CE Mark for Jazz Cap System
Implanet received the CE Mark for its Jazz Cap System, a device for securing screws in poor-quality bone.
The single-use, sterile implants were developed for the main purpose of supporting the treatment of degenerative conditions in adult patients.
The system includes a set of implants consisting of a screw, a band and the company’s patented locking mechanism.
PerkinElmer Earns CE-IVD Mark for Prenatal Testing Device
PerkinElmer earned a CE-IVD mark for its Vanadis non-invasive prenatal testing (NIPT) platform.
The test allows patients to screen for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome) and trisomy 13 (Patau syndrome).
The device measures maternal plasma via targeted fluorescent labeling and the counting of specific cfDNA fragments, removing data-intensive steps required by gene sequencing or microarray testing.
Millar Gains CE Mark Expansion for Pressure Catheter
Millar received an expansion of its Mikro-Cath pressure catheter CE mark to include airway and intra-compartmental pressure measurements.
The pressure catheter previously received European approval for making cardiovascular pressure measurements, and it received FDA clearance in March 2017 for the expanded indications.
The expansion allows physicians to continuously monitor patient compartment pressure and accurately diagnose acute compartment syndrome, a medical emergency usually caused by internal bleeding or swelling tissue that can lead to permanent muscle damage.
Mesa Biotech Gains 510(k) Clearance for RSV Test
The FDA granted Mesa Biotech 510(k) clearance for its Accula respiratory syncytial virus (RSV) molecular point-of-care test. The test received the CE Mark in Europe earlier this month.
The test diagnoses RSV, which is highly contagious and frequently affects young children and elderly adults, who experience more serious complications from the virus.
The test is designed for use with the company’s polymerase chain reaction testing platform, which was specifically made for point-of-care infectious disease diagnosis.
FDA Clears Astura Medical’s Spinal Fixation System
Astura Medical’s Olympic posterior spinal fixation system has been granted 510(k) clearance by the FDA.
The top loading thoracolumbar, sacral and iliac fixation system offers surgeons a range of posterior spinal fixation instruments and implants to provide fixation during spinal fusion.
The device is made up of preassembled polyaxial and monoaxial screws, rods, rod connectors and crosslinks.
E-Motion Earns CE Mark for Stimulation Therapy System
E-Motion Medical received the CE Mark for its stimulation therapy system, a device intended to treat patients with acute gastrointestinal dysmotility.
The digestive systems of patients with acute gastrointestinal dysmotility have muscles that do not function properly in terms of strength, speed or coordination.
The device gives off “unique patterns” of electrical stimulation to the patient’s esophagus using a tube. The stimulation delivered by the system causes the esophagus to contract, restoring the digestive system’s natural function and promoting gastrointestinal functioning.
OrthoXel Cleared for Femoral Nailing System in Europe
OrthoXel received the CE Mark for its Apex femoral nailing system, marking another clearance for the device after it recently received a nod from the FDA.
The device, used for fixating femoral fractures, gives physicians numerous locking options, such as the company’s patented micromotion for controlled axial movement that encourages callus formation.
Varian’s Cancer Treatment System Receives Chinese Approval
Varian’s Halcyon system has been given the go-ahead from the China National Medical Product Administration (NMPA), allowing the company to market the cancer treatment system.
The device has already received approvals in the U.S., EU, Japan, India and Brazil.
The image-guided radiotherapy offers advanced treatments for lung, breast, prostate, head, neck and other forms of cancer.
Medical Device Supplier Initiates Recall of Bipolar Pacing Leads
Florida-based medical device company Oscar issued a Class I recall for certain lots of its temporary bipolar pacing leads.
The TB Unshrouded Bipolar Pacing Leads are used to stimulate or pace the heart to increase a patient’s heart rate. They are placed into a vein and advanced until the tip touches the inside of the heart.
The company said that in certain lots of the pacing leads, the connector cap housing may shift and expose the internal wire, risking loss of connectivity or breakage during cable movement that could prevent the external pulse generator from pacing, which could be fatal.