From disappointing Getinge earnings to a $2.25 billion U.S. Defense Department contract for Cardinal Health to a host of 510(k) clearances, here are seven recent medtech stories that are still worth a mention. 1. Getinge disappoints on earnings—again Getinge stock took a nearly 10% tumble last week after releasing earnings that Reuters says lagged analyst […]
FDA
FDA warns device makers over unapproved claims
U.S. FDA recently released 2 warning letters to companies that it claims are marketing products for unapproved medical uses. London-based Medical Specialties of California UK has sold its Penguin Cold Caps in the U.S. for the purpose of reducing hair loss for chemotherapy patients, according to FDA. Santa Ana, Calif.–Rapid Release Technologies has meanwhile gone […]
RTI Surgical names new CEO, parts ways with CSO Hartill | Personnel Moves | January 31, 2017
RTI Surgical (NSDQ:RTIX) named Camille Farhat as its chief executive officer, effective March 15, 2017. Previously, Farhat served as president & CEO of American Medical Systems, Inc., where he helped facilitate Boston Scientific (NYSE:BSX)’s $1.65 billion acquisition of the men’s and prostate health businesses. He has also held leadership positions with Baxter (NYSE:BAX), Medtronic (NYSE:MDT) and General Electric (NYSE:GE). “Today […]
Trump and medtech: What people in the industry think
Many MassDevice and Medical Design & Outsourcing readers think permanent medical device tax repeal should be a top priority for President Donald Trump and the Republican Congress. Many say the new administration will be good for medtech, too. Those were two of the major takeaways among nearly 100 MassDevice and MDO readers responding to an online […]
Statement from FDA Commissioner Robert Califf, M.D. announcing FDA Oncology Center of Excellence launch
Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers. The FDA is taking important steps to formalize […]
FDA Advisory Committees: Independent, Informed, Essential, and Evolving
By: Robert M. Califf, M.D. One of the most common concerns raised when I meet with medical leaders is the need to improve the function of FDA’s Advisory Committees (ACs). ACs play a key role in FDA’s decision-making process by providing independent expert advice on extraordinarily complex issues. Just as importantly, they offer a forum […]
Introducing IMEDS, a public-private resource for evidence generation
By: Robert M. Califf, M.D. FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities, including regulated industry, to conduct large scale evaluations of safety issues in an environment that is secure and protects patient privacy. These evaluations include epidemiologic studies of medical […]
FDA’s CDRH reveals guidance plans for FY2017
Heather Thompson, MDO senior editor CDRH is setting its goals along with the rest of us for the new year. The agency has published and prioritized its intentions for FY2017, starting with a list of new documents it intends to release in FY2017 (A-list). It has also shared a B-list of previously-issued final guidances for […]
Managing medical device cybersecurity in the postmarket: At the crossroads of cyber-safety and advancing technology
By: Suzanne B. Schwartz, M.D., M.B.A. Protecting medical devices from ever-shifting cybersecurity threats requires an all-out, lifecycle approach that begins with early product development and extends throughout the product’s lifespan. Today, we’re pleased to announce that industry now has advice from FDA across this product continuum with the release of a final guidance on the […]
21st Century Cures Act: Making progress on shared goals for patients
By: Robert M. Califf, M.D. Today, President Obama signed into law the 21st Century Cures Act, which, I am pleased to report, builds on FDA’s ongoing efforts to advance medical product innovation and ensure that patients get access to treatments as quickly as possible, with continued assurance from high quality evidence that they are safe […]
Better tool to help assess LASIK Patients
By: Malvina Eydelman, MD LASIK (laser-assisted in situ keratomileusis) eye surgery is an alternative for patients who need glasses or contacts to see well. Some 600,000 to 800,000 patients undergo LASIK in the U.S. each year, and a very high number of those patients are satisfied with their surgical outcomes. However, some patients develop unwanted […]