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. Read More
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. Read More
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. Read More
The U.S. FDA has released a draft guidance for the use of data monitoring committees (DMCs) for clinical trials for devices and drugs, which would overwrite a similar guidance from 2006. This new draft guidance explicitly states that clinical studies more commonly employ DMCs than was the case 18 years ago and would seem to suggest that the agency will more routinely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. Read More
In 2023, med-tech firms garnered a total of $17.68 billion in funding, marking a 53.85% decline from the $38.31 billion raised in 2022 and ranking as the lowest financing year documented by BioWorld MedTech. This decrease follows a 22.3% dip from 2021’s $49.3 billion. The top-value year in med-tech financings remains 2020, recording $59.7 billion, followed by 2021’s $49.3 billion. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ascensia, Binx, Cardinal Health, Emed, Imaware, Link, Science 37, Sensome, Think Surgical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Orano Med, Radiomedix, Samsung Electronics, T2 Biosystems. Read More
