Last year, herd immunity seemed like a comforting promise as researchers worked on dozens of COVID-19 vaccine candidates and a silver-lining to the rampant spread of the virus — the more people who got infected, the more natural immunity that would develop over time. There are now dissenting opinions about how the term relates to […]
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Acutus Medical names new chief financial officer
Acutus Medical (Nasdaq: AFIB) today announced that it appointed David Roman as its CFO, effective March 1. Founded in 2011, Carlsbad, Calif.–based Acutus Medical boasts a portfolio of electrophysiology products that includes catheter-based treatments for cardiac arrhythmias. Roman has more than 15 years of experience in the medical technology industry. Prior to joining the company, […]
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 […]
Authorities investigating death of California recipient of COVID-19 vaccine
Last week, Norwegian officials raised eyebrows when they announced that they were investigating the deaths of 23 elderly patients who had recently received COVID-19 vaccine doses. Now, California authorities are investigating the death of a Placer County-based patient who received a COVID-19 vaccine dose on Jan. 21. The patient died hours afterward. Placer County officials […]
How continuous glucose monitors have transformed the diabetes landscape
Continuous glucose monitors (CGMs) are among the most potent diabetes management tools to emerge in recent decades. FDA approved the first professional CGM in 1999, and the technology has evolved swiftly since then. Current models beam data via Bluetooth to smartphones (plus the Apple Watch) and the cloud, enabling patients to explore their blood glucose […]
FDA takes ‘STeP’ toward safer devices
The FDA has released final guidance for a new, voluntary review process that would streamline its review of devices and device-led products designed to treat non-life-threatening diseases and make available medical treatments safer. Modeled on the agency’s breakthrough devices program, the Safer Technologies Program (STeP) would cover devices that could improve the safety of treatments […]
New Croatian notified body designated to European MDR
By Ronald Boumans, Emergo Group UDEM Adriatic d.o.o., based in Zagreb, Croatia, is a new name in the EU Notified Body community. They have been officially listed in the European database for Notified Bodies, NANDO, designated for the upcoming Medical Devices Regulation (EU) 2017/745 (MDR). Their Notified Body number is 2696. UDEM is not listed […]
Ensuring safe and effective distribution of COVID-19 vaccines
By Stewart Eisenhart, Emergo Group As governments, industry and other entities begin COVID-19 vaccine distribution efforts worldwide, cold chain management has emerged as a crucial factor for ensuring vaccine safety and effectiveness. 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 […]
Clinical study sponsors may become non-EU post-Brexit
By Ronald Boumans, Emergo Group The departure of the United Kingdom from the European Union on January 1, 2021, has many consequences. Clinical investigations with medical devices as well as clinical performance studies with in vitro diagnostic devices are impacted, as are clinical studies with medicinal products. In this respect, Brexit means that sponsors and […]
Key steps for medical device manufacturers effective CAPA management
By Sarah Fitzgerald and Stewart Eisenhart, Emergo Group Ensuring adequate processes for corrective and preventative action (CAPA) management is a critical step for medical device manufacturers implementing ISO 13485:2016 or other quality management systems. However, effective CAPA management can prove a perennial challenge even to larger, more mature manufacturers. Get the full story here at […]
How UKNI will mark medical devices placed on the market in Northern Ireland after Brexit
By Ronald Boumans, Emergo Group Based on the current course of the UK’s planned withdrawal from the European Union by the end of 2020, an examination of how medical device market entry in Northern Ireland will be impacted is due. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
