Aerin Medical Inc.’s funding nosed up to $190.5 million with its latest venture capital round, which brought in $60 million in fresh cash. The provider of noninvasive solutions for chronic nasal conditions plans to use the funds to ramp up commercialization and expand market access to its Vivaer and Rhinaer products. New investor Ally Bridge Group led the round with support from returning major investors KCK Medtech, Questa Capital and Orbimed.
Adaptive Biotechnologies Corp. launched T-Detect Lyme, a T-cell-based clinical test to detect immune response activated by Borrelia burgdorferi, the bacterial species of spirochete that causes Lyme disease. The CLIA-validated laboratory-developed test (LDT) is meant to help diagnose early Lyme disease in adults showing signs and symptoms of the tick-borne illness.
Los Angeles-based cancer diagnostics company Nonagen Bioscience Corp. obtained CE marking for its Oncuria immunoassay for bladder cancer. The multiplex urine test is designed to detect the concentration of 10 proteins that are associated with bladder cancer in urine samples. Clinical studies found the test has a 93% sensitivity and 93% specificity for detecting bladder cancer. The test is also designed to predict whether people are more likely to respond to bacillus Calmette-Guérin (BCG) therapy, a first-line treatment for bladder cancer.
Just three months after raising $10 million from its IPO on the Paris Euronext Growth market, SMAIO SA (Software Machines and Adaptive Implants in Orthopedics) obtained U.S. FDA 510(k) clearance for its Balance Analyzer 3D surgery planning software and for its patient-specific union rods. This spinal realignment planning software uses medical imaging of the patient’s spine in an upright static position.
The U.S. FDA is among the regulators that are taking account of the views of patients in medical device development and regulation, but artificial intelligence (AI) and machine learning (ML) are terra incognita for many, if not most patients. Rebekah Angove, vice president for patient experience and program evaluation at the Patient Insight Institute, told BioWorld that while some patients clearly want to know more about AI and ML, it is also clear that more than a certain amount of detail is more of a distraction than a help for most patients.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nonagen Bioscience.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apdyne Medical, Conformal, Innovia, Monaghan Medical, Nasoneb.
China will continue to ramp up volume-based procurement (VBP) policies that bring down drug and device prices for public hospitals with volume. Governmental agencies at the local and national levels coordinate drug prices via government-organized procurement programs that include VBP and pricing negotiations for inclusion on the National Reimbursable Drug List.
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