Meril Life Sciences Pvt Ltd. recently launched its next-generation transcatheter heart valve (THV), the Myval Octapro THV, which it says is unique and 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.

Industry dismayed by limits spelled out in FDA’s draft guidance for PCCPs

The U.S. FDA’s August 2024 draft guidance for predetermined change control plans (PCCPs) for all device types is in principle a groundbreaking regulatory document, but industry has many misgivings about the draft. Both the Medical Device Manufacturers Association and the Advanced Medical Technology Association blasted the draft’s limitations on the scope of the changes that could be included in a PCCP, but the agency may not agree with industry’s interpretation of the statutory underpinnings of the PCCP concept.

FDA unveils pilot program for improved device recall transparency

The U.S. FDA announced a new pilot program for communication of corrective actions and other recalls a manufacturer undertakes, but there is a catch. The focus of this program will be on recalls the agency believes “are likely to be high-risk recalls,” suggesting the FDA may be prone to overreacting to manufacturer’s corrective actions for a problem that ultimately proves to be less hazardous than the agency assumes.

Averrto’s brain blood flow monitor alerts to stroke

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 which monitors blood flow to the brain, detects changes and provides real-time alerts to enable timely, efficient treatment.

Also in the news

Amsino, AWS, Bioservo, Cascaid Health, Femasys, Foresight Diagnostics, Helio Genomics, Icad, Icometrix, Inspiremd, Kane Biotech, Lifecore Biomedical, Limb Lab, Lunit, Medxl, Merit Medical, Natera, Nexalin, Nuvo Group, Oxford Nanopore, Philips, Qiagen, Relevium Medical, Roche, Salud Digna, UK Biobank, Uromems, Viz.ai