Medtronic (NYSE:MDT) today said it would acquire insulin pen manufacturer Companion Medical for an undisclosed amount. Companion Medical’s product portfolio includes the InPen FDA-cleared smart insulin pen system that is paired with an integrated diabetes management app on the market. It is designed to help calculate insulin doses, track active insulin and send reports to caregivers […]
How COVID-19 impacts FDA interactions with medical device manufacturers
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed […]
Xeris Pharmaceuticals launches autoinjector for severe hypoglycemia
Xeris Pharmaceuticals today said it has launched its Gvoke HypoPen glucagon injection to treat severe hypoglycemia. The autoinjector is designed to treat severe hypoglycemia in adults and children with diabetes that are ages two years and older. The premixed autoinjector has no visible needle and has a reliable delivery method. According to the company, 99% […]
Inivata launches lung cancer liquid biopsy test
Inivata today announced it has launched its InVisionFirst Lung liquid biopsy in the U.S. through a commercial partnership with NeoGenomics. The device is a ctDNA next-generation sequencing liquid biopsy assay testing 37 genes that are relevant to the care of advanced non-small-cell lung cancer. The results are delivered within seven days and the test is […]
This wearable patch could treat skin cancers
Researchers at Purdue University have developed a wearable patch that could bring an improved treatment experience to people with melanoma. Conventional melanoma therapies leave patients suffering from the toxicity and side effects of repeated treatments because of aggressive and the recurrent nature of melanoma cells, according to the researchers. The Purdue University wearable patch features […]
China issues new procedures for medical device registration
By Timothy Herr, Emergo Group China’s Center for Medical Device Evaluation (CMDE) issued two announcements recently outlining revised procedures relating to medical device registration. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or its […]
How EU MDR and human factors affect design user-friendly software user interfaces
By Kimmy Ansems and Linda Giesselink, Emergo Group Emergo by UL’s Human Factors Research and Design team has extensive experience developing software user interfaces and instructional materials for various medical devices. In the fourth blog post in our series on the European Medical Devices Regulation (MDR) and human factors engineering, we reference various MDR General […]
MDR delay impact extends beyond European Union
By Timothy Herr, Emergo Group While we have reported on the one-year delay of Europe’s Medical Devices Regulation (MDR) due to the COVID-19 pandemic, we have not yet touched on the ramifications that this decision has on countries outside the European Union. The United Kingdom and the nations of the European Free Trade Association (EFTA) […]
Insulet resumes next-gen Omnipod pivotal study following software issues
Insulet (NSDQ:PODD) today said it has resumed its pivotal study of its next-generation Omnipod Insulin Management System after pausing the study in March due to a software anomaly. The company paused the study about halfway through completion to correct an issue that could result in the system using an incorrect glucose value that had the potential to impact […]
IMDRF recommends UL 2900 compliance for medical device cybersecurity
By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
