Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Siemens Healthineers.
Tensive Srl 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.
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, but anyone who was expecting a clear break with the 2019 version of the guidance was almost certainly disappointed.
In a big week for W.L. Gore & Associates Inc., the company reported plans to acquire Conformal Medical Inc. and received U.S. FDA approval for its Viabahn Fortegra venous stent for use in the inferior vena cava, iliac and iliofemoral veins.
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 likely will present challenges.
Med-tech firms raising money in public or private financings, including: Brightheart, Carna Health, Catalio Capital Management, Flywheel, Vicentra, Vizgen, Volitionrx.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amra Medical, Butterfly Medical, Electrome, Genedx, Komodo, Labcorp, Materna, NAMSA, Neuralight, One Genomics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accukardia, Cmr Surgical, Reflexion Medical, Saluda Medical, Sky Labs, Xenex.
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