The U.S. FDA released another series of regulations for de novo devices, but the attendant regulation is not always available for these de novo devices.
Australia’s Therapeutic Goods Administration recently reported that it has concerns about the use of digital scribes, stating that any such software that analyzes or interprets clinical conversations may qualify as a regulated medical product.
Neuroone Medical Technologies Corp. expanded into treatment of chronic pain with a new U.S. FDA clearance for use of its Onerf system to treat trigeminal nerve pain. The system uses radiofrequency ablation to disrupt pain signals from the nerve to the brain.
AI and machine learning products have proven complicated for regulatory authorities across the globe, but entities in the business of conducting health technology assessments also have their hands full according to several sources.
In a regulatory round-up, the U.K. Medicines and Healthcare Products Regulatory Agency opened a survey regarding in-house device manufacturing, the EU Notified Bodies staffed up last year and the Singapore Health Sciences Authority and the Hong Kong Department of Health agreed to share information.
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.
In less than two weeks, Setpoint Medical Inc. mastered the power serve with the first approval of a neuroimmune modulation device to manage rheumatoid arthritis, followed by a $25 million second tranche of its series C and a $115 million series D financing round.
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