Varian Medical Systems Inc. received an investigational device exemption (IDE) from the U.S. FDA to start a clinical trial evaluating its new radiation therapy. The experimental treatment, named Flash, delivers radiation at ultra-high dose rates, typically in less than one second. The Siemens Healthineers AG company said the therapy is capable of being over 100 times faster than conventional radiation therapy. Read More
The COVID-19 pandemic completely rewrote the script for government responses to communicable diseases, and thus the Biden administration is wasting no time reacting to the emergence of the monkeypox virus. The administration announced June 28 that it has developed a plan to allocate the distribution of large volumes of vaccines, but the CDC has shipped tests to five major commercial lab companies, thus putting the U.S. on a strong footing to respond to the outbreak. Read More
Joining a growing number of diagnostics companies mobilizing to minimize the spread of monkeypox, Novacyt SA and Seegene Inc. reported they have developed new polymerase chain reaction (PCR) assays to quickly diagnose the disease this week. Roche Holding AG released three monkeypox tests for research use in late May. Abbott Laboratories and Becton Dickinson & Co. have similar plans. Stanford Medicine made its own diagnostic available to its patients last week. Read More
After three years of clinical research, Royal Philips NV said its Tack (4-F) endovascular system has shown promising results for arterial dissection repair following balloon angioplasty in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. The data was collected from a 36-month follow-up in the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee clinical trial. Read More
The U.S. FDA reported a proposed down-classification for two device types intended for detection of melanoma, a move that would ease the premarket path for similar devices. The agency noted that it has received only one PMA application each for optical diagnostic devices and electrical impedance spectrometers, which suggests the agency sees these device types as suffering for want of interest on the part of device makers. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biobridge, Bioporto, Clarius, Evolent, Fuzionaire, Gencure, Harbinger Health, Neuralace, Reflow Medical, Spinex, Terumo, Verisim. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Moleculight, Seegene. Read More
