Deephealth Inc., a subsidiary of Radnet Inc., completed the acquisition of breast health solutions company Icad Inc. in a $110 million all-stock transaction. The company also received U.S. FDA 510(k) clearance for Techlive – a remote scanning solution enabling centralized operation and supervision of MR, CT, PET/CT and ultrasound procedures. Read More
The U.K. Medicines and Healthcare products Agency (MHRA) is calling for more research into the vaginal microbiome as a way to redress the historic under-representation of women in clinical studies, which it said has contributed to “critical shortcomings” in understanding of female-specific conditions. Read More
Nyxoah SA may now help make dreams come true here in the U.S. with its FDA approval for the Genio system for the treatment of obstructive sleep apnea. Read More
The issues facing the EU’s Medical Device Regulation and the In Vitro Diagnostic Regulation are the stuff of legend, but the EU’s notified body group, TEAM NB, has proposed a mechanism to deal with some of the administrative problems. Read More
The FDA’s warning letter to Whoop Inc. resurrects questions about the agency’s observance of the 21st Century Cures Act in that the warning letter stakes out the position that any reading of blood pressure is “inherently associated” with hypertension. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ainnova Tech, Aquedeon Medical, Caro Health, Clarimed, Fortrea, Healthcare Outcomes Performance, Ocular Therapeutix, Nanopalm, Rakovina, Renata, We Are Human. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Enable Injections. Read More
