Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nanjing Changcheng Medical Equipment, Guardant Health, Gendius, Icecure Medical, Medimaps Group, Rapid Medical, Techsomed.
The U.S. FDA recently posted another round of recalls for the Cardiosave line of intra-aortic balloon pumps (IABPs) by Datascope Corp., advising users to make sure they have a backup unit at the ready in the case of device failure. However, the agency noted that “alternative treatments are limited,” a clear sign that this market lacks competition, most likely due to a lack of incentives for the private sector to invest in this class of devices.
Amber Therapeutics Ltd. has acquired Bioinduction Ltd. as well as its neuromodulation therapy platform, Picostim Dyneumo. Amber is currently using the platform, an implantable system to deliver its closed-loop therapy for mixed urinary incontinence, Amber-UI, in a first-in-human study. With early indications confirming the safety and feasibility of the surgical procedure and adaptive therapy, it made sense to acquire the hardware which allows for the therapy to work, CEO Aidan Crawley, CEO and co-founder of Amber told BioWorld.
The proposed U.S. Medicare framework titled Transitional Coverage for Emerging Technologies (TCET) promises to expand on existing mechanisms for Medicare device coverage, but industry has serious misgivings about the proposal.
When the data and safety monitoring board (DSMB) for Biocardia Inc.’s phase III pivotal trial of its Cardiamp cell therapy for heart failure advised pausing the study in July to analyze the interim results, the company expressed confusion as there were no reported treatment-emergent safety issues and aggregated blinded data showed better than expected outcomes. With the recommended external analysis now complete, the company confirmed the study is unlikely to achieve its primary endpoint at one year. The trial has now been unblinded.
Stimlabs LLC has taken a new view of wound healing by developing a fenestrated dehydrated complete human placental membrane allograft for chronic and acute wounds. The fenestration in the Release product allows fluids to drain away from the wound, promoting faster healing, while the tissue provides protection.
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