Vergent Bioscience Inc. raised $21.5 million in a series B financing round to advance development of VGT-309, its targeted fluorescent imaging agent that illuminates tumors during open, minimally invasive and robotic-assisted surgeries. The company plans to use the funds to support a phase II trial at the University of Pennsylvania that focuses on lung cancer and a multicenter study that will examine the agent’s use in other indications. Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) has given Intuitive Surgical Inc. the green light for its Da Vinci SP surgical system. The surgical system has been cleared for use in general surgeries, thoracic surgeries (excluding cardiac procedures and intercostal approaches), urologic surgeries, gynecological surgeries, and trans-oral head and neck surgeries. Read More
The U.S. FDA’s finalized guidance for clinical decision support (CDS) software was not an entirely isolated policy change inasmuch as there were several other guidances that were edited and reissued two days after the CDS final was published. One of these is the guidance for device software functions and mobile medical apps, which now encodes a transparency requirement as seen in the CDS guidance, a change that may represent a hazard for the unwary medical software developer. Read More
At first glance, Cellarity Inc. might appear as one more company harnessing the computational power of AI and machine learning to boost drug discovery efforts. A closer look, however, reveals a different approach, one that looks at cells and cellular behavior to address disease rather than the traditional method of seeking out molecular targets. Read More
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) announced recently that it is considering an increase in the fees it levies on industry for a variety of services and actions, such as premarket applications. One of these is a 10% indexation increase in all statutory fees, but there are also some proposed increases in cost recovery charges and an additional 22 new fees for cost recovery that would be new to applicants seeking access to the U.K. market. Read More
Teva Pharmaceuticals USA Inc.’s quest to get the U.S. Supreme Court to overturn the Federal Circuit and preserve label carveouts, or so-called skinny labels, continued Oct. 3 with the high court asking the solicitor general to weigh in. Read More
New hires and promotions in the med-tech industry, including: Exactech, Exagen, Haemonetics, Intervenn Biosciences, Quantum-Si, Saluda Medical, Visibly. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Azenta, B Medical, Esaote, Hanger, Hearusa, Immucor, Pirche, Reddress, Vapotherm. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Multi Radiance Medical, QT Medical. Read More
