The U.S. FDA has given its nod to Novalung, a heart and lung support system from Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure. The Waltham, Mass.-based company noted that Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use. Read More
NATIONAL HARBOR, Md. – Berlin-based Biotronik SE & Co. reported new data from the BIOFLOW-V trial showing that its Orsiro ultrathin strut drug-eluting stent (DES) continued to outperform Abbott Laboratories’ Xience DES through three years’ follow-up. Read More
Liquid biopsy has long been seen as key to the future of cancer diagnostics, treatment and even potentially prevention. But now, startup Karius Inc. has staked out its claim as the first to bring cell-free DNA analysis, which is often used in oncology and prenatal liquid biopsy applications, into the clinic for infectious disease detection, identification and treatment guidance. Read More
Developers of artificial intelligence (AI) algorithms have their own nightmares to deal with, but the FDA is charged with employing a regulatory touch that steers clear of rocky shoals on one side and inescapable whirlpools on the other. The FDA’s Bakul Patel said during a Feb. 25 workshop that the FDA would quickly be swamped if the agency took a traditional regulatory approach to managing the super-iterative digital health space, but that the agency will keep a keen eye on the potential impact on patients as AI begins to move into clinical practice. Read More
PARIS – The Syndicat National de l'Industrie des Technologies Médicales (SNITEM), the French national association of medical technology manufacturers, has just released a study looking at the development of this industrial sector in that country. This snapshot, produced every two years by the firm D&Consultants SAS on behalf of Courbevoie, France-based SNITEM and the bank Bpifrance SA, is based on a dual quantitative and qualitative approach. Read More
“The FDA is keenly aware that the outbreak will likely affect the medical product supply chain, including potential disruption to supplier shortages of critical medical products in the U.S.,” FDA Commissioner Stephen Hahn said Tuesday, Feb. 25, during a Department of Health and Human Services (HHS) briefing on the COVID-19 outbreak. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akili, Avinger, One Drop, Physiq, Proscia. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adchim, Advion, American Brivision, Analog Devices, Artizan Biosciences, Beijing Bohui Innovation Biotechnology, Biomatrix, Bwx Technologies Certara, Cove, Ekso Bionics, Gerpang Healthcare Group, Gn Hearing, In Silico Biosciences, Interchim, International Health Technologies, Kindred Healthcare, Masimo, Miroculus, Milestone Scientific, Mologic, Ms Westfalia, Natus, Nemaura Medical, Pinpoint Science, Red One Medical, Redox, Resound, Siemens Healthineers, Theranica Bioelectronics, Trianni, Twist Bioscience, Welldoc. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altair Medical, Asuragen, Avanos Medical, Cynosure, Emagine Solutions Technology, Emcyte, Fujifilm, Kurin, Zynex. Read More
Keeping you up to date on recent developments in oncology, including: Study demonstrates time travel possible for pancreatic cancer; Angle’s Parsotix fares well in new study; New technique boosts utility of organoids; Smart microwaves take on breast cancer. Read More
