Alpha Tau Ltd. has secured a second breakthrough device designation for its Alpha Dart radiation treatment for solid cancer tumors. The FDA has granted the Jerusalem-based company’s technology a designation for the treatment of patients with recurrent glioblastoma multiforme (GBM), an aggressive malignant brain tumor. GBM has an average five-year survival rate of less than 10% and is the most common malignant tumor of the brain or central nervous system. According to the designation, the Alpha Dart system can be used to treat recurrent GBM as an adjunct to standard medical therapies or as a standalone therapy after standard medical therapies have been exhausted.

The least burdensome principle is a critical component in industry’s understanding of the proper role of government regulation, but this principle is the subject of considerable tension between the two sides. The latest report on the FDA’s performance under the fourth device user fee agreement noted that device makers raised the least burdensome flag in less than 0.5% of 510(k) submissions filed between February 2019 and April 2021, but the report gives the agency passing grades on its handling of those potentially controversial regulatory encounters.

After nearly two years of waiting, Withings SA won FDA clearance for its Scanwatch, a smartwatch that can take an electrocardiogram and monitor for sleep disturbances indicative of sleep apnea or respiratory illnesses such as chronic obstructive pulmonary disease. The FDA action makes the watch the first cleared for both functions.

FDA preemption of state liability law has proven controversial on a number of occasions, a fact of life resurrected by a case arising out of the Supreme Court of the State of Mississippi. The court declared that the FDA must invoke the rulemaking process for its regulation of medical product labels.

The FDA’s push toward safety has included an examination of the materials used in medical devices, but a recent report sheds little useful light on whether these materials are provoking a response in patients.

The term of follow-up in clinical studies is the subject of massive speculation at FDA advisory hearings, but a recent FDA workshop suggests the agency may adjust its expectations, depending on the device. Darrell Brodke, of the University of Utah, said on a recent spinal device workshop that the two-year endpoint in some spinal device studies struck him as somewhat arbitrary, adding that a longer duration of follow-up is necessary to capture some device failures, but that two years is perhaps overly long where some other outcomes measures are concerned.

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.

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.

The FDA reported two class I recalls associated with insulin pumps made by Dublin-based Medtronic plc, albeit for two significantly different issues. The two recalls affect roughly 495,000 units combined, and may significantly affect access to some patients. One of the recalls was for Minimed 600 series insulin pumps, a recall announced in 2019 and expanded in October. The recall addresses the risk of incorrect dosing of insulin due to a faulty clear retainer ring, which is used to lock the insulin cartridge into place in the insulin pump reservoir. The second recall is for remote controllers used with Medtronic insulin pumps. In this instance, the action was undertaken due to cybersecurity concerns, although the controllers in question are no longer in distribution.