A preliminary prospectus has been filed by Valeritas for a public offering of around 44.1 million shares of common stock and Series A and B share purchase warrants, up from about 27.8 million shares and warrants filed for previously.
A public offering of approximately 2.1 million Class A common shares has been priced by Helius Medical Technologies at $8.25 each.
Aetna has issued a positive coverage policy for Pulmonx's Zephyr endobronchial valve system, naming it as an approved bronchoscopic option for lung volume reduction. The device is designed for treating severe emphysema and chronic obstructive pulmonary disorder.
NuVasive has launched the Brigade Lateral implant for lateral anterior lumbar interbody fusion spine surgery. The implant provides a low-profile and reproducible insertion process to improve surgical workflow in the operating room.
Researchers from Loyola Medicine and Loyola University Chicago conducted a 22-patient proof-of-concept study of response-guided therapy that reduced the time and cost of hepatitis C treatment. The data were presented at the annual meeting of the American Association for the Study of Liver Diseases.
The FDA has warned StemGenex Biologic Laboratories for selling an unapproved stem cell product as part of a crackdown on sales of regenerative medicines for unapproved indications. The warning letter also noted manufacturing process violations that could create a risk of microbial contamination.
Regenxbio's RGX-181, being developed as a one-time therapy for late-infantile neuronal ceroid lipofuscinosis type 2 disease, was given orphan drug status by the FDA.
The FDA has granted Canon Medical Systems USA clearance to market its Vantage Orian 1.5 Tesla MRI scanner, which comes with a 71 cm bore, as well as Pianissimo and Pianissimo Zen technologies for quiet operation.
European regulators have given Diabeloop CE mark approval for its DBLG1 technology, a self-learning and customizable device for monitoring and maintaining glucose levels. The system, which can imitate the insulin-dispensing functions of the pancreas, connects to an insulin patch pump and a continuous blood glucose monitoring system to predict glucose levels and enable optimal pump control.
Testing by the Government Accountability Office revealed that two dietary supplements, which were sold as ginkgo-based memory boosters, do not contain the ingredient or contain a lower amount than marketed. The FDA will review the GAO report and may conduct further investigation.