Israeli med-tech startup Forsight Robotics Ltd. has closed a $10 million seed funding round led by Eclipse Ventures and joined by Mithril Capital. The funding will help advance the company’s work on a surgical robotic platform that employs microsurgical robotics, computer visualization and machine learning to automate many of the complex elements of ophthalmic surgery. Read More
The Advanced Medical Technology Association’s (Advamed) new board chairman, Michael Minogue, president and CEO of Abiomed Inc., noted that the association’s agenda for 2021 includes considerations of several headwinds. However, Advamed President and CEO Scott Whitaker said the Medicare Coverage of Innovative Technologies (MCIT) program should commence March 15 as planned, despite the overhang of the Biden administration’s regulatory review of all orders posted in the last days of the Trump administration. Read More
The U.S. FDA has granted emergency use authorization (EUA) to Breath Direct Inc. for its BDR-19 critical care ventilator for the treatment of critical care patients with respiratory insufficiency. Initial shipments of the device are expected within weeks. The EUA marks a major milestone for the fledgling Long Beach, Calif.-based company, which was started by medical device entrepreneur Darren Saravis in the early days of the pandemic. Read More
I-O Urology Corp. launched its Carepath platform to provide remote patient monitoring for urologic conditions. The platform uses a compact portable system to capture real-time urine voiding data and a mobile app to facilitate accurate reporting and timely communication between patients and their health care providers. Read More
LONDON – New research shows it is possible to diagnose Parkinson’s disease by mass spectrometry analysis of sebum samples taken with a simple skin swab, and that the same technique has potential to be used for diagnosing COVID-19. In a paper published in Nature Communications on March 11, 2021, scientists and clinicians in the U.K. and the Netherlands describe using high resolution mass spectrometry to profile the chemical signature of lipids and other biomarkers in sebum from Parkinson’s patients and show how these exhibit subtle but fundamental changes as the disease progresses. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Alafair Biosciences, Barm Advanced Communications, Bioventus, Certara, Ibex Medical Analytics, Integrated DNA Technologies, Iridex, Ligolab, Merit Medical Systems, Mevion Medical Systems, Microbix Biosystems, Mission Bio, MVP Health Care, Nemaura Medical, Perflow Medical, Persephone Biosciences, Proscia, Rhinostics, Roche, Shanghai Focus Healthcare, Swift Biosciences, Teleflex. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Berlin Heart, Canam Scientific, Clordisys Solutions, Sd Biosensor, Zymo Research. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIH touts new polygenic risk score methodology; HHS extends comment period for HIPAA NPRM. Read More
Keeping you up to date on recent developments in diagnostics, including: Quality of smartphone-transmitted skin images; A noninvasive test for kidney transplant rejection; Fungal culprit in Crohn’s disease. Read More
