Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
- Optasia Medical wins FDA 510(k) clearance for SpineAnalyzer
Sudbury, Mass.-based Optasia Medical Inc., a leading image analysis software applications provider announced that it has received 510(k) clearance from the Food & Drug Administration for SpineAnalyzer, a workflow tool for the quantitative assessment of vertebral deformities in patients at risk of osteoporosis. The output of the device may be used by physicians to assist in the diagnosis of vertebral fractures, a key factor to determine if therapeutic intervention is indicated.
- PCI receives FDA 510(k) clearance for on-site oxygen generators
PCI, a designer and manufacturer of on-site gas separation systems, received FDA 510(k) clearance to market their oxygen generators (known as deployable oxygen concentrator systems, or DOCS) as medical devices. These medical devices generate and deliver USP grade 93 percent ± 3 percent oxygen.
- HemCon Medical Technologies wins Japanese clearance for bandage products
HemCon Medical Technologies Inc. is pleased to announce that its partner in Japan, Zeria Pharmaceutical Co. Ltd. obtained regulatory clearance from the Ministry of Health Labor and Welfare for the HemCon Bandage, GuardaCare and ChitoGauze product lines and will begin sales through Zeria’s subsidiary, Zeria Shoji Co. Ltd. In accordance with the agreement signed between HemCon and Zeria in April of last year, other products in the HemCon family will be added to Zeria’s offerings in the coming months, with various distribution and sales mechanisms to be employed.
- Ornim Inc. lands FDA clearance for non-invasive brain oximetry and blood flow monitoring
Ornim Inc. is pleased to announce the receipt of 510(k) clearance from the FDA to market the CerOx 3210F monitor. Additionally to its previous clearance for non-invasive monitoring of regional hemoglobin oxygen saturation in the brain or skeletal muscle, the CerOx 3210F is now also intended for use as a non-invasive monitor of blood flow in tissue of adults. The CerOx 3210F is currently the only device to use a single, non-invasive probe for simultaneously and independently measuring both oximetry and blood flow parameters, together providing a clear indication of tissue perfusion.
- MIT China receives Chinese approval for MED-JET products
Medical International Technology Inc. (OTC:MDLH) is pleased to announce its progress in China. Based on the results obtained in two separate pivotal clinical trials over the past six months, the Chinese SFDA authorities have approved and issued to our Joint Venture Corp. the official licence to sell MED-JET products.