Longeviti Neuro Solutions LLC has received the U.S. FDA’s nod for use of its Clearfit cranial implant with postoperative ultrasound imaging. The expanded 510(k) clearance could help in reducing radiation exposure linked to other post-neurosurgical imaging modalities. Research has shown that current methods of post-neurosurgical imaging put patients at risk of radiation exposure, and that an estimated 29,000 future cancers could be linked to CT scan used in the U.S. each year. Comprised of polymethyl-methacrylate (PMMA), Clearfit is a neuro-reconstructive implant that surgeons use to reconstruct a patient’s cranium following brain surgery. Read More
Orthospin Ltd.'s outlook was braced by the U.S. FDA's 510(k) clearance of its next-generation digitally enabled, robotic external fixation system. The Autostrut G2 system allows preprogramming of external fixation devices used for orthopedic issues such as lengthening bones, setting complex fractures and correcting deformities. Read More
Health care professionals (HCPs) might prefer a new respirator for each shift, but the ongoing shortage has left clinical sites with a need to employ dry heat for filtering facepiece respirator reuse. The U.S. FDA said on a Jan. 26 town hall that it will stick to an established policy that these devices can be processed with dry heat no more than five times, a practice that is likely to stick for the foreseeable future despite that administrators are required to provide fresh units when possible. Read More
IBM Research and Boston Scientific Corp. are harnessing artificial intelligence (AI) to create an objective pain measurement tool that could someday replace standard patient-reported pain scales in the assessment of chronic pain. Read More
PERTH, Australia – Sydney-based Cyclopharm Ltd. raised AU$30 million (US$23.19 million) in a private placement that will enable the company to launch its Technegas combination product in the U.S. Read More
In signing an executive order (EO) on strengthening American manufacturing Jan. 25, President Joe Biden made it clear that the order is aimed at more than infrastructure. While Biden’s Build Back Better Recovery Plan calls for investing hundreds of billions of dollars in buying American products and materials to modernize the nation’s infrastructure and increase its competitiveness, “it also means replenishing our stockpiles to enhance our national security,” the president said. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Asieris, Bc Platforms, Chronomics, Curadigm, Dante Labs, Digbi Health, Echosens, Electrocore, Emocha, Fuzionaire Radioisotope Technologies, Gastrologix, Genedx, Nanobiotix, Nihon Medi-Physics, Nova Mentis Life Science, Orasure, Opko Health, Perkinelmer, Photocure, Qualigen, Sanofi, Soliton, Soundbite, Yi Xin. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aktiia, Alleviant, Inspired Spine, Longeviti, Spinal Elements. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Epigenomics out in Medicare NCD for CRC screening; TGA tweaks registration process for class I goods; Global initiative to take on Alzheimer’s; More on EMA cyberattack. Read More
Keeping you up to date on recent developments in oncology, including: Hypoxia a potential marker for recurrent glioblastoma; SCLC subtypes have specific vulnerabilities; Few-shot learning may speed up drug development; New research may move up breast cancer diagnosis. Read More
