Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenda, Bodyport, Bot Image, Cerevasc, Imspex Diagnostics, Medalliance, Neuroone.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 908 Devices, BD, Brainscope, Labcorp, New England Donor Services, Rockley Photonics, Specialist Direct, Trace Analytics.
When medical device manufacturers think of U.S. federal government enforcement, the Sarbanes-Oxley Act (SOX) of 2002 might not be the first element of the statute to come to mind. However, the Securities and Exchange Commission (SEC) used SOX to snare Suralign Holdings Inc. for pushing orders to customers ahead of schedule to draw the related revenue forward, an allegation that led to restitutions and penalties amounting to nearly $3 million.
Sengine Precision Medicine Inc. boosted its total fundraising to $19 million with the recent closing of a $10 million series A2 led by the Washington Research Foundation with support from Alethea Fulcrum Fund, Vincere Capital Biotech LLC, Bangarang Group and others. The A2 follows on an earlier $5 million raised in the original series A. Sengine’s Paris Test predicts drug responses using a patient’s cancer cells to grow a tumor organoid that replicates the functionality and genomic characteristics of the original tumor, enabling hyper-personalization of cancer treatment.
Data on C2N Diagnostic LLC’s new blood test combining a proprietary p-tau217 measurement with the amyloid beta (a-beta) 42/40 ratio, a component of C2N’s commercially available PrecivityAD blood test, could help to predict people at risk for Alzheimer’s disease (AD) – even at the earliest stages.
The U.S. FDA has updated its data on the number of fatalities across globe associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has now reach 59 fatalities. That number is up from 33 reported in July 2019 but is also a number the agency continues to assert may be a significant undercount.
Epigenetic test company Volitionrx Ltd. appointed contract research organization (CRO) Diagnostic Oncology CRO LLC (DXOCRO) to conduct development and clinical validation studies for its Nu.Q product portfolio in the U.S. DXOCRO will carry out large-scale finding studies across the U.S. using Henderson, Nev.-based Volition's cancer tests to determine clinical utility in sepsis and cancer. The trials are aimed at U.S. FDA approval of the products.
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