One in five breast cancer conserving surgeries leaves behind some of the tumor. That means patients must schedule a second surgery and then endure additional pain, infection risk, recovery time and cost. Cairnsurgical Inc.'s Breast Cancer Locator system may change that by providing 3D tools that enable surgeons to precisely tailor resection to the shape, size and location of each tumor. Read More
Boston Scientific Corp. has received a thumbs up from the U.S. FDA for its fourth-generation Vercise Genus deep brain stimulation (DBS) system. The neuromodulation device, which comes in both rechargeable and nonrechargeable versions, is intended to treat the symptoms of Parkinson’s disease. Vercise Genus is indicated for use in the bilateral stimulation of subthalamic nucleus as an adjunctive therapy in alleviating some of the symptoms of moderate to advanced lepodova-responsive Parkinson’s disease that are not adequately controlled by medication. It also has indications for bilateral stimulation of the globus pallidus. Read More
The portable hemodialysis market is heating up. For example, Quanta Dialysis Technologies Ltd. recently made a splash by receiving clearance from the U.S. FDA to market its portable hemodialysis system SC+. According to the Alcester, U.K.-based company, SC+ can deliver the higher dialysate flow rates typically used to provide conventional three-times-a-week prescriptions, while also offering the flexibility for more frequent, longer and gentler treatments tailored to patients’ needs. Read More
The storm of controversy over the use of paclitaxel in devices for the peripheral vasculature had a dramatic effect on utilization, but a new study coming out of Sweden seems to have helped further ease concerns about purported mortality associated with this antiproliferative. While this unplanned interim analysis lends yet more support to the view that the mortality signal in the so-called Katsanos paper did not reflect a true biological finding, the net effect of the controversy has prompted a call for a registry that might eliminate some statistical noise that had a significant and harmful impact on patients. Read More
PERTH, Australia – Following consultation with medical device stakeholders in 2019 and 2020, the Therapeutic Goods (Medical Devices) Regulations 2002 were amended to clarify some existing requirements and to introduce new requirements for software-based medical devices. The new rules that go into effect on Feb. 25, 2021, clarify the boundary of regulated software products, introduce new classification rules, and provide updates to the essential principles for software-based medical devices. Read More
Med-tech firms raising money in public or private financings, including: Advanced Oncotherapy, Cloudbreak Health, Gigcapital2, Uphealth Holdings. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alung Technologies, Calcula, Conformis, Elekta, Exagen, Crescita, Orthopediatrics, Ready, Sartorius, Sites Medical, Stedim Biotech, Viewray, Worldwide Clinical Trials. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Fluidigm. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed urges administration to communicate on DPA; FDA posts third-party report for Q1, FY 2021. Read More
Keeping you up to date on recent developments in neurology, including: Personalized neuromodulation technique developed for obsessive-compulsive behavior; Improving pain research with new sensory neuron model; Tau end run prevents memory deficits, but not inflammation; Presenilin mutations affect neuronal stem cells. Read More
