Tensive S.r.l reported positive data from its pivotal trial confirming the safety profile of Regenera, its bioabsorbable breast implant, and its potential to transform breast reconstruction. The pivotal trial evaluating the Regenera in patients undergoing lumpectomy found it to be safe, biocompatible and feasible for volume replacement in breast-conserving surgery.
FDA’s new general wellness guidance is no dramatic overhaul
The U.S. FDA’s reissuance of the 2019 guidance for general wellness products seems to carve out new territory for makers of wearables that make modest claims regarding health. Observers who were hoping for a paradigm shift in how the agency views these devices may be disappointed, however, given that the guidance makes modest concessions at most about the regulatory status of these types of products.
Gore inks deal for Conformal Medical
W.L. Gore & Assoc. Inc. agree to acquire Conformal Medical Inc., developer of the Claas Acuform system for left atrial appendage occlusion. The deal is expected to close early this year. The companies did not disclose financial details.
High pressure areas predicted for 2026 device landscape
It doesn’t take a meteorologist to see the storm clouds of uncertainty that will continue to roll in on health care across the globe this year. While the prospects for the medical device industry may be sunnier than for other aspects of health care, some high pressure areas may present challenges. “The health care sector is entering 2026 amid a perfect storm of political, financial and operational pressures,” said Rita Numerof, president of Numerof & Associates Inc. “Across the board, organizations are being forced to adapt. To succeed, they must fundamentally rethink their business models to demonstrate value, manage risk and improve outcomes.”