The FDA has greenlighted Neuronetics Inc.’s Neurostar transcranial magnetic stimulation (TMS) system as an adjunct treatment for adults with obsessive-compulsive disorder (OCD). The noninvasive treatment, which uses repetitive, focused magnetic pulses to stimulate brain cells, is already cleared and marketed in the U.S., Japan and select other countries for major depressive disorder (MDD). Read More
As the American Urological Association (AUA) annual meeting prepares to kick off on May 12, newly published prostate cancer guidelines recommend two tests to help clinicians and patients determine the best path forward for treatment—or waiting. The latest AUA guidelines incorporated Exact Sciences Corp.’s Oncotype DX Genomic Prostate Score (GPS) test for risk-stratification of localized prostate cancer, while the National Comprehensive Cancer Network (NCCN) added Cleveland Diagnostics Inc.’s Isopsa test to help identify high-grade early prostate cancer before a biopsy or after a negative biopsy result. Read More
The legislation that would renew a number of FDA user fee programs, the Food and Drug Amendments Act (FDA Act) of 2022, has passed the first legislative hurdle in a subcommittee of the U.S. House of Representatives, but there are several issues with the bill. According to members of the subcommittee, the issues include an absence of provisions for medical device servicing, and the absence of legislation for FDA regulation of lab-developed tests (LDTs), issues that are unlikely to be resolved before the legislation is passed out of the House. Read More
With its focus on transformative high-risk, high-reward research to drive biomedical breakthroughs, the new Advanced Research Projects Agency for Health (ARPA-H) may be a good concept, but it shouldn’t come at the expense of increased investment in basic research at the NIH, according to the bipartisan leadership of U.S. House appropriators. Read More
In the post COVID world, digital transformation is at the forefront of every company’s agenda, but which innovations can fuel the next era of health care? At the ongoing Biomed Israel conference in Tel Aviv, Anat Naschitz founder and CEO of 9xchange and co-founder of Orbimed Israel, lead a digital health track exploring the technologies aiming to reconstruct the future of health care. Read More
At the ongoing Biomed Israel 2022 event, Magneto Thrombectomy Solutions Ltd. has shared successful first-in-human (FIH) results showing safety and feasibility of its Etrieve system, a novel catheter based on electric fields for removing blood clots, in patients with acute pulmonary embolism (PE). Read More
New hires and promotions in the med-tech industry, including: Acera Surgical, Beta Bionics, Fairtility, Physiq, Prophase Labs, Uromems, Virta Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inex Innovate, Neuronetics. Read More
