Japan Approves Elekta’s Icon
Elekta’s Leksell Gamma Knife Icon has been cleared for clinical use by both the Japanese Ministry of Health, Labor and Welfare and the Nuclear Regulatory Commission in the United States.
Icon is used in radiosurgery for brain tumors and vascular malformations. The device uses integrated stereotactic cone-beam CT (CBCT) imaging technology that monitors cranial position using infrared marker tracking. The system can check a patient’s position against the treatment plan and automatically recalculate the plan to correct for movement.
The product received 510(k) clearance from the FDA in August 2015.
Nasolacrimal Compression Device Class I
The FDA is classifying the nasolacrimal compression device as Class I, effective June 10.
This classification was based off of Innovatex’s request for Class I designation for its Tear Duct Occluder (originally referred to as the Glaucoma Companion Nasolacrimal Compression Device) on June 27, 2014.
A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.
MHRA Update on QRISK 2 Investigation
MHRA issued an update on errors associated with the TPP QRISK 2 Calculator, which detects the potential risk of cardiovascular disease.
The MHRA initiated an investigation following reports of inaccurate results of the calculator that runs on the UK-based company’s SystmOne clinical software. The agency notes that the issues pose little risk to patients.
Doctors are advised to identify patients with incorrect scores in need of reassessment, and to explore different avenues to minimize the risk of heart disease, if necessary.
Oventus Releases 3D-Printed O2Vent
Australian medical device company Oventus Medical will unveil its flagship medical device, the O2Vent, for the treatment of snoring and sleep apnea in the U.S.
The 3D-printed O2Vent is custom-fitted to a patient’s mouth and directs air to the back of the mouth. It is an alternative treatment to continuous positive airway pressure (CPAP) treatment.
A recent study showed snoring was eliminated in 82 percent of patients along with improved oxygen levels during sleep.
In March 2016, the device received 510k clearance in the U.S. and is expected to be available later this year.