Approvals
Quidel Receives FDA Clearance for Solana Assay
Quidel received marketing clearance from the FDA for the Solana respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) assay.
The assay uses Quidel’s novel reverse-transcriptase amplification technology, generating results for 12 samples in approximately 45 minutes.
Solana received a CE Mark in August.
FDA Approves New Nebulizer for Tyvaso Inhalation System
United Therapeutics received FDA approval for its TD-300/A inhalation device for use with its Tyvaso (treprostinil) inhalation solution.
Tyvaso is a vasodilator indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.
Tyvaso was originally approved by the FDA for the treatment of PAH in 2009, under a new drug application covering a drug-device combination consisting of the drug, an ultrasonic nebulizer and accessories.
Renishaw Wins FDA Approval for Neurosurgery Planning Software
The FDA granted 510(k) clearance for Renishaw’s neuroinspire software that blends MRI and CT datasets into a 3D format, enabling neurosurgeons to identify regions deep within the brain tissue.
The device is designed to minimize the chance of hitting key anatomy during the procedure.
Neurosurgeons can use the software to create plans based on procedure type with tools tailored to the procedure.
Medineering Wins CE Mark for Its Positioning Arm
Munich, Germany-based Medineering received a CE Mark from the European Commission for its Positioning Arm to position passive adapters and robots in ear, nose and throat surgery, neurosurgery and spinal surgery.
The company describes the product as the basis of “a completely new concept of robotic assistance.”
The technology is designed to assist surgeons in complex anatomical areas.
Ortek Wins Marketing Clearance for Cavity Detection Device
Ortek Therapeutics received 510(k) clearance for its electronic dental cavity detection device. The tabletop unit allows dental professionals to diagnose and monitor cavities in the biting surfaces of molars and premolars.
The device detects tiny lesions in the tooth enamel before a cavity is formed, and measures the amount of dentinal fluid in the pits and fissures of molars and premolars.
Tooth enamel is electrically non-conductive unless breached by a fracture or demineralization. The more fluid the device detects, the greater the severity of the lesion.
Acutus Gets FDA Clearance for Advanced Cardiac Mapping Technology
Acutus Medical received FDA clearance for its AcQMap high resolution imaging and mapping system and the AcQMap 3D imaging and mapping catheter.
The system combines ultrasound anatomy construction with the ability to map the electrical-conduction of each heartbeat to identify complex arrhythmias.
Medacta Receives FDA Clearance for Anatomic and Reverse Shoulder Systems
Medacta received marketing clearance from the FDA for the Anatomic Shoulder and Reverse Shoulder components of its modular Medacta Shoulder System.
The device’s instrumentation and implants allow for anatomic restoration, resulting in an efficient surgery. The modular system features wide-ranging sizes, adjustable offset, and innovative configurations.
Nitiloop Wins FDA 510(k) Clearance for Microcatheters
Nitiloop received FDA marketing clearance for its new Nova Cross Extreme and Nova Cross BTK.
The microcatheters combine low profile technology with enhanced guidewire and catheter support for safer and more effective lesion crossing.
Alcyone Wins CE Mark for Alivio Ventricular Catheter and Flusher System
Alcyone Lifesciences received a CE Mark for its Alivio ventricular catheter and flusher system for the treatment of Hydrocephalus.
The shunts are implantable devices inserted by neurosurgeons to treat hydrocephalus, a condition in which an excess of cerebrospinal fluid accumulates in the ventricles and can increase intracranial pressure in the brain, creating a potentially life-threatening condition.
The system, used in conjunction with any CSF shunt, is designed to unblock ventricular catheters.