Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Dexcom, HFWL, Myra, SC Johnson, Sentientlight.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BTL Industrires, Subtle Medical.
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.
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.
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.
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