Meril Life Sciences Pvt Ltd. recently launched its next generation transcatheter heart valve (THV), the Myval Octapro THV, which it says allows for better operator control for precise positioning and improved predictability in implantation. The new valve comes however, as the company battles with Edwards Lifesciences Corp. in a European court over patent infringement of its technology.
The FDA’s August 2024 draft guidance for predetermined change control plans (PCCPs) for all device types has provoked some misgivings among industry, with both the Medical Device Manufacturers Association and the Advanced Medical Technology Association blasting the draft’s limitations on the scope of the changes that could be included in a PCCP.
The FDA announced a new pilot program for communication of medical device recalls, but industry may be wary of a program that seems to be driven toward early notification of what the agency believes “are likely to be high-risk recalls.” The agency’s device center states that this latest effort is designed to “improve the timeliness of communications” of corrective actions undertaken by device manufacturers. This would apply when the corrective action is as significant as a device removal and when the corrective action constitutes nothing more than an update to a product’s instructions for use.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Femasys, Helio Genomics, Merit Medical, Nexalin, Viz.ai.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Qiagen, Roche.
In what represents just the company’s second PCT filing, Aderet, Israel-based Averrto Medical Ltd. continues to build protection for its system for early stroke intervention that monitors blood flow to the brain, detects changes and provides real-time alerts to enable timely, efficient treatment.
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