Regulatory agencies are starting to catch up on their guidance agendas, including the European Union’s Medical Device Coordination Group (MDCG), which has posted a guidance for risk classification. Rather than provide a list of risk classes for specific device types, the guidance provides a framework by which the manufacturer does its own evaluation of the inherent risk of the device, opening the door to disagreements between the manufacturer and its notified body.

TORONTO – Radialis Medical Inc. has submitted FDA premarket notification for a positron emission tomography system (PET) that targets specific organs for low dose imaging and may be flexible enough to assess many different diseases. The Radialis PET camera is under clinical investigation at Toronto’s University Health Network and Princess Margaret Cancer Center for its ability to assess anomalies in breast cancer.

Less than two weeks after Japan’s MHLW became the first regulatory agency to clear avacopan for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, the FDA has followed suit. It cleared the oral, small-molecule C5aR antagonist for use as an adjunct therapy for adults with the two main forms of the rare autoimmune renal disease, granulomatosis with polyangiitis and microscopic polyangiitis, in combination with standard therapy.

Two innovators in the concussion assessment space have advanced their products with new funding and new clearances. Brainscope Co. Inc. secured $35 million in capital through an intellectual property-based funding arrangement with Aon plc to expand access to and develop new applications for its EEG-based product. Syncthink Inc. received a second FDA clearance for its Eye-Sync platform for mild traumatic brain injury diagnosis.

Even though the U.S. already has a National Plan to Address Alzheimer’s Disease, a bipartisan group of U.S. senators is adding its voice to that of nearly 200 national organizations and experts in calling for more. In a recent letter to Health and Human Services (HHS) Secretary Xavier Becerra, the 15 senators requested that he make reducing the prevalence of dementias a departmental priority.

If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients.