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.
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.
Magassist Co. Ltd. has been granted a breakthrough device designation by the U.S. FDA for its interventional ventricular assist device (VAD), which is expected to accelerate the development and approval of the product.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rapid Medical.
The German med-tech associations Bvmed and VDGH have hit out at the shortcomings of the EU medical device regulations and are calling for action to improve implementation, predictability and transparency of the system.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femasys, Livanova.
Aion Biosystems Inc. may be operating at a fever pitch right now, with FDA 510(k) clearance in hand for the company’s Itempshield device, which provides continuous measurement of body temperature. The company is targeting use of the quarter-sized device for patients with cancer and individuals in long-term care.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aion Biosystems, Bionicm.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ICU Medical.
India is taking steps to separate how it regulates medical devices and pharmaceuticals, as it works to reduce its dependency on imports of devices and turn itself into a global hub for med-tech innovation and manufacturing.
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