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An early feasibility study is finding that hydrogel injected into lumbar spinal discs is safe while substantially relieving chronic low back pain caused by degenerative disc disease (DDD). Read More
The FDA issued Stand Aid of Iowa a Form 483 that listed several deficiencies seen in previous inspections, including inadequate procedures for nonconforming products and for assigning serial numbers to finished devices. Read More
A user of SoClean’s device for cleaning continuous positive airway pressure (CPAP) devices is seeking a federal class action lawsuit against the company, claiming that the cleaning machine leaks toxic ozone gas. Read More
The test is intended to monitor diabetes patients and as an aid in screening and identifying patients who may be at risk for developing diabetes. Read More
The FDA’s Special 510(k) application review can offer devicemakers the path of least resistance to market clearance, an official from the FDA’s Center for Devices and Radiological Health (CDRH) said, as long as the device meets specific criteria. Read More