Carthera SA raised €37.5 million (US$40 million) in a series B funding round that will allow the company to embark on the first pivotal trial of its Sonocloud technology. The Sonocloud-9 is the only implantable ultrasound device that can repeatedly open the blood-brain barrier and deliver effective treatment in patients with recurrent glioblastoma, Frédéric Sottilini, CEO of Carthera, told BioWorld. Read More
At the American Diabetes Association (ADA) Annual Meeting this weekend, Medtronic plc provided an update for investors and showcased results from its devices that all demonstrated better time in range for users. The Dublin-based company provided strong results with the U.S. FDA warning letter now behind it and the 780G Minimed pump and Guardian 4 sensor launches well underway. Read More
With a new medical device policy, India is laying the groundwork for a spurt in domestic manufacturing and to emerge as an innovative and globally competitive in the space, which is currently heavily reliant on imports. The new National Medical Devices Policy 2023, approved by the government at the end of April and notified in May, aims to place the Indian medical devices sector on an accelerated growth path. Read More
Sotera Health Holdings LLC has finalized a $408 million settlement for litigation over the company’s use of ethylene oxide (EtO) at a Sterigenics facility in Willowbrook, Ill., although litigation is still pending in connection with sites in other U.S. states. The news comes as med-tech trade associations register their disappointment with an EPA proposed rule for EtO that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (Advamed) argue would crimp availability of sterilization capacity, which would in turn create shortages of medical devices and supplies that are desperately needed by patients. Read More
The U.K. National Institute for Health and Care Excellence (NICE) has undertaken a public consultation for a series of proposed changes to its procedures for evaluating medical devices and other medical technologies that could speed up these reviews. This new process would require a less time-consuming approach to evaluating lower-risk technologies that would not only turn around such evaluations more rapidly but would also leave more resources available for higher-risk products that would also enjoy a timelier review, thus potentially accelerating adoption of all these products in the National Health System. Read More
Med-tech firms raising money in public or private financings, including: Augmedics, Flywheel, Microbot Medical, Pacific Biosciences, Presidio Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biodesix, Biosig, Cardinal Health, Cranius, Northstar Medical Radioisotopes, Nucleus Radiopharma, Owlet, Reified Labs, Thirona, Tivic. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Invo Bioscience, Roche. Read More
