An underwritten public offering of common stock has been launched by Merit Medical Systems in hopes of obtaining $125 million. Net proceeds from the offering, which includes a 30-day option for underwriters to purchase up to $18.75 million worth of shares of common stock, will be used for repaying debt under the company's existing credit facility.
Common Mistakes When Automating Your QMS Automating your quality management system can transform your path to compliance with FDA, ISO, and GxP. This white paper with companion checklist explores the benefits of a centralized QMS, common pitfalls and best practices when expanding or transitioning to automated quality management. DOWNLOAD NOW.
Symetis, a Swiss company that develops devices for transcatheter aortic valve replacement, has started an initial public offering of shares on Euronext Paris in hopes of raising up to approximately $69.4 million. The proceeds will be used for internal product development, expansion of manufacturing capacity, working capital and licensing or acquisition activity.
A round of equity financing involving 16 unnamed investors has brought in $10.5 million for Boulder, Colo.-based EndoShape, according to a filing with the SEC. The company, which makes minimally invasive plugs and coils for vascular occlusion, did not disclose how it intends to use the proceeds.
An agreement has been announced by MDxHealth allowing Lab21 to become a nonexclusive distributor of its SelectMDx prostate cancer test in the UK. The deal calls for Lab21 to deliver liquid biopsy samples for testing to MDxHealth's clinical diagnostic lab in the Netherlands and provide the diagnostics company with reimbursement for testing services; the companies did not disclose additional terms of the deal.
Bradford Smith, chief financial officer at Ocular Therapeutix, will step down from his position at the end of the month, according to a filing with the SEC. Meanwhile, Chief Operating Officer James Fortune will take over duties as principal accounting officer and principal financial officer at the company.
The worldwide market for colonoscopy devices is expected to reach $2 billion by 2021 with a compound annual growth rate of about 5%, according to a Technavio report. Factors driving market growth include the emergence of minimally invasive surgical procedures and guidelines issued by health care organizations.
Reimagine the life science patient experience The life science industry is undergoing rapid transformation, driven by consumer empowerment, clinical innovation and outcomes-driven health care policy. In this changing landscape, medical device and pharmaceutical companies are striving to connect with patients and deliver the best possible experience before, during and after therapy. Learn more.
InVivo Therapeutics said its nonclinical studies module, the first of three modules required to complete a humanitarian device exemption submission, has been submitted to the FDA for its neuro-spinal scaffold. The company anticipates acceptance of the module in the third quarter and intends to present its manufacturing module to the agency in the second half of the year and its clinical module next year.
European regulators have given Masimo CE mark approval for noninvasive blood pressure measurements for its Rad-97 Pulse CO-Oximeter and connectivity hub. The device, which offers Masimo's upgradeable rainbow noninvasive blood constituent monitoring technology and measure-through motion and low perfusion set pulse oximetry in a compact standalone monitor configuration, allows for arterial blood pressure measurement for neonatal, pediatric and adult patients.
A hearing was held Tuesday by the Senate Health, Education, Labor and Pensions Committee to discuss reauthorizing the FDA user fee programs and their importance in streamlining approvals of medical products, days after the Trump administration proposed a 2018 budget seeking higher user fees than what the industry agreed to. AdvaMed supports the MDUFA IV package because "it is good for patients, good for innovation and good for the agency," said President and CEO Scott Whitaker.
An updated guidance for lateral interbody fusion in the lumbar spine has been issued by the UK's National Institute for Health and Care Excellence supporting the clinical efficacy of NuVasive's eXtreme Lateral Interbody Fusion procedure. NuVasive said the guidance change was supported mostly by evidence gathered from peer-reviewed journal articles with 14 years of data from its XLIF procedure.
March 29-30 | Washington, D.C. During this workshop you'll establish a clear understanding of how the regulatory affairs function is pivotal to every recall and every team decision. After partaking in detailed discussions and strategies of communicating with the FDA, you'll learn to understand the points to consider when writing public recall notifications. At this interactive workshop, you will have access to network with industry leaders and FDA experts. Learn more.
The AdvaMed Purchasing Group is a new member-only benefit that helps companies purchase the very best goods and services from nationally recognized suppliers at the very best cost, using a trusted and proven vetting system and the collective purchasing power of our membership. Participation is free for AdvaMed members, and there are no minimum commitments. Get started today.