Reflecting enthusiasm for a radiotherapy that can target multiple tumors simultaneously, Reflexion Medical Inc. closed an $80 million series E fundraising round to support development of its biology-guided radiotherapy (BgRT) technology for metastatic cancer. New investors included Ascension Ventures, Catalio Capital Management LP, Sixty Degree Capital Inc. and Hillenbrand Capital Partners LLC. Read More
The FDA has cleared a plasma collection device developed by Terumo Blood and Cell Technologies (Terumo BCT) and plasma collection network CSL Plasma. The companies, which are subsidiaries of Terumo Corp. and CSL Ltd., signed a collaboration deal in 2021 to develop the new Rika device for CSL Plasma collection centers. The automated technology is designed to reduce plasma collection time to 35 minutes or less. According to the Red Cross, plasma donations currently take on average about 1 hour and 15 minutes. Read More
Ceros Capital Markets completed a $15 million series D funding round for Pristine Surgical LLC, its latest major investment in the medical device space. The funds will be used to advance the commercialization of Pristine’s single-use visualization platform for surgical and diagnostic endoscopic procedures. Read More
Developed by Infrascan Inc., the FDA-cleared Infrascanner device was touted as the first hand-held device to help detect bleeding in the skull and supported financially by the U.S. military anxious to treat moderate to severe traumatic brain injury in wounded service members. The FDA has now expanded the Infrascanner’s use to traumatic intracranial hematomas or brain bleeds in pediatric patients aged 2 years and older. Read More
The list of FDA warning letters in recent months has conspicuous in its absence of letters to device makers, but that trend has reversed with three warnings posted March 8, including a warning letter to Cardioquip LLC. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Audere, Medical Diagnostech, Nexstim, Royal Philips. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Philips. Read More
