Portable dialysis machine manufacturer Outset Medical Inc. saw its shares soar after the opening of its Nasdaq IPO. The stock rose as high as $61.60 before closing at $60.68, finishing the day with a market cap of nearly $2.5 billion. Trading under the ticker symbol OM, the company priced 8.95 million of its shares at $27 apiece, upsizing its previously reported plans to offer 7.6 million shares between $22 and $24. The offering is set to close Sept. 17. Read More
Sinusitis implant company Intersect ENT Inc. has agreed to acquire Fiagon AB Medical Technologies, a manufacturer of electromagnetic surgical navigation systems, for €60 million (US$71.1 million). Under the terms of the agreement, Intersect ENT will pay €15 million at the time of the closing and €15 million annually for the ensuing three years. Read More
Siemens Healthineers AG snagged a key role in the mystery playing out across the world's pandemic stage – what do antibody test results mean in terms of immunity to SARS-CoV-2 and how do different tests assessing different proteins compare? The U.S. CDC and the Joint Research Centre (JRC) of the European Commission tapped the Erlanger, Germany-based company to take the lead in developing a process to standardize antibody assays. Read More
The U.S. FDA has been easing gently down the road of real-world evidence (RWE) in regulatory decision-making, and the case of the Watchman left atrial appendage device is instructive in this regard. Robert Shipley, of Boston Scientific Corp. (BSX), said on webinar hosted by the Advanced Medical Technology Association that the FDA changed gears and agreed to a registry for a post-approval study for the first generation Watchman, but added that the use of registry data and other RWE for approval of a next-generation device is as yet more aspirational than practicable. Read More
What’s the plan? The U.S. CDC is being asked that question a lot these days – not just about COVID-19, but also about preparing for what could be a tough influenza season as flu bugs circulate with the coronavirus. Read More
The FDA has granted Plus Therapeutics Inc. fast track designation for its lead candidate, Rhenium Nanoliposomes (RNL), for treating recurrent glioblastoma, propelling it into the sixth cohort of a phase I dose-finding trial. Read More
Raising more money in the first three quarters of 2020 than in each of the last three full years, the med-tech industry is mirroring that of the biopharma industry, showing an unprecedented amount of financing during what is arguably the most economically disruptive pandemic in a lifetime. Read More
New hires and promotions in the med-tech industry, including: Apiject, Clearpoint Neuro, Element Science, Experity, Microbix, Orthofix, Prolucent, Rapid Micro Biosystems, Satellite Healthcare, Varian. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerapedics, Controlrad, Eurobio Scientific, Fibralign, GE Healthcare, Genmark Diagnostics. Read More
Keeping you up to date on recent developments in oncology, including: New algorithm prioritizes breast cancer patients for surgery, chemotherapy; Oxygen grows tumors but shrinks metastasis chances; ‘Fight or flight’ nervous system helps fight tumors, too; Proton beam therapy available in South Florida. Read More
