The U.S. FDA has released a draft guidance for the use of data monitoring committees (DMCs) for clinical trials for devices and drugs, which would overwrite a similar guidance from 2006. This new draft guidance explicitly states that clinical studies more commonly employ DMCs than was the case 18 years ago and would seem to suggest that the agency will more routinely require the use of DMCs than was common practice in the past.

The U.S. FDA recently convened an advisory hearing to review the agency’s list of essential items for public health emergencies and led the hearing with its own list to which the advisory committee recommended numerous additions. How the FDA will respond remains to be seen, but the FDA’s list may grow significantly larger despite that industry representatives advised that existing supply chain redundancies would seem to suggest that some devices and associated items need not be subject to FDA supply chain oversight.

It’s been a good month for Illuminoss Medical Inc. In less than three weeks, the East Providence, R.I.-based company received U.S. FDA clearance of its new light-emitting diode (LED) console, achieved the 10,000th use of its bone-strengthening technology and presented promising results of research on use of its signature blue light for antimicrobial applications.

Biopsies from up to 14% of patients with non-small-cell lung cancer (NSCLC) showing resistance to epidermal growth factor receptor (EGFR) tyrosine kinase therapy ascertain histologic transformation (HT) to SCLC, which is estimated to kill around 250,000 patients globally, every year. In a study published in Science on Feb. 9, 2024, researchers from Weill Cornell Medicine have dissected that complex process using a genetically engineered mouse model of pulmonary HT.

Elemind Technologies Inc. may not (yet) be telepathic, but the new company certainly read the mood of investors well as it secured $12 million in seed funding before emerging from stealth this week. While the product has yet to be fully revealed, the company is developing a wearable neurotechnology platform that uses artificial intelligence to read and guide brainwaves using tailored sound stimulation.

In its first full year since its spin-off from parent company General Electric Co., GE Healthcare Technologies Inc. reported beating Wall Street’s expectations. For 2023, revenues of $19.6 billion grew 8% organically vs. 2022.

The International Medical Device Regulators Forum will meet in Washington in March 2024, a location which would seem to guarantee robust attendance. The meeting agenda includes an extensive amount of time for specialized regulatory pathways, an effort to promote the incentives for development of orphan and pediatric devices across the globe.

The new year kicked off with med-tech deal value in January totaling $107.75 million. By the numbers, January’s 183 deals surpassed the 2023 monthly average of approximately 142 deals per month.

A team of Johns Hopkins University researchers have filed for patent protection of a system and method to determine patient prioritization for triage during mass trauma events. The system and method may continuously monitor patient parameters to determine patient prioritization over time, which may improve the speed, quantity, and efficacy of life-saving interventions.