The Prevena Duo incision management system has been launched by Acelity in the US. The single-use negative-pressure wound therapy system lessens postoperative complications during bilateral procedures by helping clinicians manage two closed surgical incisions simultaneously.
The FDA has granted Bio-Rad Laboratories 510(k) clearance for enhanced options with its IH-Com patient results management software, a data-management tool designed for use with the IH-1000 automated blood-typing platform. The software provides overall interpretation and crosscheck using a combination of current and previous patient results, aids in the transfer of data to lab information systems and enables linking of instruments inside and across laboratories.
The scientific review of Philip Morris' marketing application for its electronically heated tobacco product, the iQOS Tobacco Heating System, has been started by the FDA's Center for Tobacco Products and is anticipated to take about a year.
Orexigen Therapeutics' Contrave DTC ad received the FDA's Office of Prescription Drug Promotion's first untitled letter of 2017, which cites a failure to include all pertinent risk information. The "Your Brain" ad, according to the FDA, advises avoiding opioid use while on the drug but does not list all conditions for which the treatment is contraindicated.
A private placement of 6.625 million units of common stock and stock purchase warrants could bring in $13.3 million for MRI Interventions. The proceeds will be used to support transfer of the company's stock listing from the OTCQB market to a major stock exchange.
Illumina is planning to expand operations in China, its biggest market outside of the US, following double-digit growth in the company's revenue there in the past two years. The plan, which comes as the company eyes expansion of its global footprint, will include collaboration with Chinese genome sequencing service companies, particularly startups, said Illumina CEO Francis deSouza.
Suwanee, Ga.-based Sanuwave Health has granted Lithomed a contract with a minimum order value of $500,000 to distribute its orthopedic products in Taiwan. Lithomed is the first of up to five distribution partners Sanuwave plans to tap in the second quarter, and the company aims to have as many as 10 partners by year-end.
A Global Market Insights report predicts the worldwide market for orthopedic devices will reach $53 billion by 2024 because of the growing incidence of arthritis and osteoporosis, an expanding aging population, the adoption of biodegradable implants and the shift toward minimally invasive surgical procedures. Among the key market players are Medtronic, Zimmer Biomet, Stryker, DJO Global, DePuy Synthes, ConforMIS and Smith & Nephew.
Medtronic saw 4.6% year-over-year revenue growth during its fiscal fourth quarter ending April 28, generating over $7.9 billion, with the fastest growth coming from its minimally invasive therapies unit. CEO Omar Ishrak said the company is making "distinct competitive advantages and capitalizing on the long-term trends in health care, namely the desire to improve outcomes; the growing demand for expanded access to care; and the optimization of cost and efficiency within health care systems."
A study of 545 women ages 25 to 50 years showed that the use of Provista Diagnostics' Videssa Breast assay in breast cancer detection may lower biopsy use by up to 67%. The multiprotein biomarker blood test was found to have 87.5% sensitivity, 83.8% specificity, 99.1% negative predictive value and 25.2% positive predictive value.