Critically ill infants in need of continuous renal replacement therapy (CRRT) are often treated using machines intended for adults, leading to a number of challenges and a high risk of complications and death. Now, Medtronic plc has launched a pediatric and neonatal acute dialysis machine in the U.S. that is specifically designed for patients weighing between 2.5 and 10 kilograms. The Carpediem Cardio-Renal Pediatric Dialysis Emergency Machine, the first of its kind in the U.S., received U.S. FDA clearance in April via the de novo pathway and is classified as a class II device. Read More
New investors think Brainsgate Ltd. has some valuable new ideas, including its novel treatment for ischemic stroke, so they headed up the latest investment round. BNP Joint Capital led the $14 million round as a first-time investor along with Spero and previous investors Elron, Medtronic, Agate, Pitango, and Cipio. Read More
Paige has received good news in the EU, securing a CE mark for its breast cancer detection software that highlights suspicious areas for pathologists to review further. It also received a CE mark for Paige Prostate Grading & Quantification, which offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning. Read More
LONDON – Retinai Medicine AG reported a three-year master agreement with Novartis AG to apply its artificial intelligence (AI) tools in ophthalmology clinical trials. The first project will look at how machine learning can be used to speed up and improve the interpretation of optical coherence tomography (OCT) images of patients with neovascular age-related macular degeneration (AMD). Read More
TORONTO – Ontario and British Columbia med-tech companies have received CA$1.4 million (US$1 million) from Ottawa’s Supercluster fund, making a difference they said for patients suffering the long-range effects of COVID-19, chronic disease and undergoing joint replacement surgery. Read More
The amount of money raised by the med-tech industry through public and private financings in 2020 is more than double the amounts seen in 2017 and 2018 and 37% above last year, despite massive global disruptions due to the COVID-19 pandemic. Read More
With the FDA perhaps days away from granting emergency use authorization (EUA) for the first U.S. COVID-19 vaccine, the Trump administration took a bow Dec. 8 at a summit called to celebrate what’s been accomplished and to explain what lies ahead in getting vaccines distributed throughout the country. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Metal-containing masks can cause injuries during MRIs. Read More
Med-tech firms raising money in public or private financings, including: Nanovibronix, Neovasc, Pear Therapeutics, Progenity, Rayzebio, Rewalk Robotics, Story Health. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allosource, Electrocore, Itamar Medical, Prelude. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mahana Therapeutics, Nanovibronix, Paige.AI, Solvd Health, Zebra Medical Vision. Read More
Keeping you up to date on recent developments in oncology, including: New theranostic nanoparticle design combines DNA wireframe and Sgc8c aptamer; Bolting TLR agonist to antibody converts cold tumors; Rule-based screening for degraders; How stress disrupts tumor cell sleep; Combo treatment shows efficacy in treatment of ALL. Read More
