Orthobond received on April 5th de novo approval for the company’s spinal fusion device with quaternary ammonium compound coating. Orthobond’s antibacterial treatment, Ostaguard™, covalently bonds its antimicrobial,...more
The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more
On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...more
The U.S. Food and Drug Administration recently announced approval for Bose to market their Bose Hearing Aid. According to the press release, the Bose Hearing Aid, which was approved through the FDA’s De Novo premarket review...more
On September 12, 2018, Apple released its new Apple Watch Series 4 with a new ECG app that can take an electrocardiogram (ECG). Apple’s new Apple Watch Series 4 has been granted De Novo classification by the FDA, which allows...more
Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the...more
The Central District of California recently dismissed, for the second time, a putative class action filed by two plaintiffs who claimed to have purchased Zeltiq Aesthetics, Inc.’s “CoolSculpting” fat-reduction treatments...more
According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform is the...more