University of Michigan computer science researcher Kevin Fu has been named acting director of medical device cybersecurity at the FDA. Fu began working in the newly created 12-month post on Jan. 1, 2021, according to the university. His assignment is to bridge the gap between medicine and computer science and help manufacturers protect medical devices from digital […]
FDA labels Boston Scientific ICD electrode recall serious
The FDA today declared the recall of a Boston Scientific subcutaneous electrode used in implantable cardioverter defibrillators (ICDs) as Class 1, the most serious. The company warned physicians in December 2020 that approximately 47,000 Emblem S-ICD1 subcutaneous electrodes (model 3501) may fracture. Boston Scientific said at the time that it had received 27 reports of […]
Steris beats The Street, announces leadership change
Steris (NYSE:STE) beat The Street on both sales and profits in its fiscal third quarter and announced that CEO Walt Rosebrough will step down July 29, 2021. The Dublin, Ireland-based sterilization and surgical products company posted profits of $114.5 million or $1.33 per share, on sales of $808.9 million for the three months ended Dec. 31, […]
Sister companies team up to launch medtech design service
Intelligent Product Solutions (IPS) and Kablooe Design announced that they have joined forces to launch an end-to-end medical device design and engineering service. Both subsidiaries of Forward Industries (NSDQ:FORD), Happauge, N.Y.-based IPS and Kablooe (Minneapolis) have complementary services, including human factors engineering, verification and regulatory support along with upfront research and testing. Get the full story on our sister site, […]
FDA clears lightweight Inovytec ventilators
Inovytec has announced that the FDA has granted FDA 510(k) clearance for its Ventway Sparrow ventilators. The 2.2 lb. transport and emergency ventilators had previously won FDA emergency authorization for use during the COVID-19 public health emergency. They are already commercialized in Europe, Canada and Australia and are undergoing registration procedures in other countries, according to […]
10 medtech hazards you need to watch out for in 2021
Patient safety organization ECRI comes out with its list of health technology hazards every year, and it often contains the same issues. The COVID-19 pandemic has changed much of that. The nonprofit organization is focusing this year on the need to move from trying to cope during an emergency to building stronger and more resilient […]
ResMed beats The Street on Q2 sales, disappoints on earnings
ResMed (NYSE:RMD) beat Wall Street analysts’ estimates for sales growth in its second quarter of 2021 but fell below their earnings projections. The San Diego-based company posted profits of $179.5 million, or $1.23 per share, on sales of $800 million for the three months ended Dec. 31, 2020, for an 11.8% bottom-line gain on sales growth […]
House committee investigates $70M federal contract for AutoMedx ventilators
A Congressional committee has launched an investigation into a $70 million White House contract for ventilators that reportedly are inadequate to treat people with COVID-19. The Department of Defense signed a $16.2 million contract in spring 2020 to buy SAVe II ventilators, manufactured by AutoMedx (Addison, Tex.), from the supplier Combat Medical Systems, according to the House Committee […]
BD touts study of antigen test over molecular test for identifying infectious COVID-19 cases
Becton Dickinson (NYSE:BDX) is touting the results of a small, in-house study of its Veritor Plus antigen test over molecular (PCR) tests to indicate whether an infected person is more likely able to spread SARS-CoV-2. The peer-reviewed study compared antigen and PCR test results to positive results using a viral cell culture test. Viral growth […]
FDA clears Theranica device for adolescent migraines
Theranica announced today that the FDA has granted expanded clearance for the use of its Nerivio acute migraine treatment device by people 12 years and older. The use of the device in the treatment of adolescents is supported by a study recently published in Headache. According to the study, 28 of 39 (71%) of the adolescent participants using […]
AdvaMed wants input on Biden pandemic DPA use
AdvaMed reacted to President Joe Biden’s plan to use the Defense Production Act (DPA) to tackle the pandemic with some cautionary words. In a letter responding to Biden’s 200-page COVID-19 plan, the medtech trade group asked for collaboration and urged the president to consider the industry’s experience with DPA orders issued by former President Trump. Get the full story […]