By Ronald Boumans, Emergo Group The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year. The European Commission has informed Emergo that parts of Eudamed will be made available to users before the official […]
Icon appoints new chief medical officer
Icon said it appointed Kristen Buck as chief medical officer. Prior to joining the company, Buck was senior VP and chief of clinical development at Optum Insights where she led the clinical operations and regulatory group. She has experience in multiple therapy areas, including GI, neuroscience, dermatology, ophthalmology, oncology, cardiovascular/metabolic, immunology, renal, women’s health, orphan […]
Kindeva Drug Delivery launches as independent company from 3M
Kindeva Drug Delivery recently announced that it launched as an independent company, shedding its former 3M Drug Delivery Systems name. The formation of the independent company follows its acquisition by Altaris Capital Partners in a transaction that was worth $650 million. Through the acquisition, 3M will hold a 17% minority interest in Kindeva with Altaris. […]
Tandem Diabetes Care posts wider-than-forecast losses in Q1
Tandem Diabetes Care (NSDQ:TNDM) posted first-quarter results that beat the revenue consensus on Wall Street but missed on earnings. The San Diego-based company — maker of insulin pumps and other diabetes management devices — reported losses of -$14.9 million, or -25¢ per share, on sales of $97.9 million for the three months ended March 31, for […]
How ISO 14971 will affect usability engineering
By Richard Featherstone, Emergo Group The third edition of international standard ISO 14971 (Medical devices—application of risk management to medical devices) is now available. This third version, dated December 2019, cancels and replaces the second edition (ISO 14971:2007). There are a number of changes, some of which relate directly to usability. ISO 14971:2019 is recognized […]
Dexcom shares up on Street-beating Q1 results
Dexcom (NSDQ:DXCM) posted first-quarter results today that beat the consensus forecast on Wall Street but dropped its financial guidance for the year. The San Diego-based company reported profits of $19.9 million, or 21¢ per share, on sales of $405.1 million for the three months ended March 31 on sales growth of 44.4% compared with Q1 2019. […]
West Pharmaceutical Services appoints VP, GM of Asia Pacific
West Pharmaceutical Services this week announced it appointed Stewart Campbell as VP and general manager of the Asia Pacific region. Campbell will be responsible for the company’s Asia Pacific business and will lead region teams. “I am honored to serve West in this critical growth market, as it represents significant business opportunities that will ultimately […]
Bio-Rad launches COVID-19 assay
Bio-Rad Laboratories (NYSE:BIO) today said it is launching is blood-based immunoassay kit to identify COVID-19 antibodies. The assay is currently undergoing clinical evaluation in several hospitals, but 700 samples of data have shown specificity above 99%. After being infected with SARS-CoV-2, viral antigens stimulate the immune system to produce antibodies and fight the virus. Bio-Rad suggests […]
BARDA opens research portal to fight COVID-19
By James Keller, Emergo Group The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response, is seeking information from stakeholders on available medical countermeasures in development. It is particularly interested in products and technologies that have progressed into […]
FDA approves BioStage’s esophageal device investigational new drug application
Biostage (NSDQ:BSTG) this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA approval. The Cellspan Esophageal Implant is designed to treat patients with end-stage esophageal disease that require segmental surgical resection to repair diseased tissue. Biostage announced the first patient was treated with the esophageal implant in August 2017. The device was […]
