Home testing company Everlywell said today that it will launch a home test kit with telehealth diagnosis for COVID-19 on Monday. The Austin, Texas-based company said it will release 30,000 tests immediately and is working with multiple labs to have testing and diagnosis capacity for a quarter of a million people weekly. Consumers who have […]
Access Vascular wins FDA clearance for HydroPICC catheter
Access Vascular this week received FDA clearance for its second-generation HydroPICC peripherally inserted central catheter. The HydroPICC has demonstrated thrombus accumulation rate 30 times less than traditional peripherally inserted central catheters (PICC), according to the company. PICCs can help reduce the risk of catheter occlusions have become a popular choice over traditional central venous lines […]
TransEnterix leases robotic surgery system to hospital in Japan
TransEnterix (NYSE:TRXC) said today that it has leased one of its Senhance robotic surgery systems to a hospital in Japan. The announcement comes nearly two months after the Research Triangle, N.C.-based company predicted lower earnings for the fourth quarter and full year of 2019 due to sluggish sales of the system. TransEnterix touts Senhance as a more […]
China CMDE publishes generic medical device names guidance
By Timothy Herr, Emergo Group China’s Center for Medical Device Evaluation (CMDE) published Announcement No. 99 of 2019, a guidance document intended to clarify the principles employed by the National Medical Products Administration (NMPA) for determining medical device generic names. This expands upon the rules previously outlined in CFDA Order No. 19. (The China Food […]
Singapore HSA revises guidance and technical reference documents
By Timothy Herr, Emergo Group On February 17, Singapore’s Health Sciences Authority (HSA) published a number of revised guidance and technical reference documents. 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 MassDevice.com or its employees.
Health Canada implements electronic medical device clinical trial data submission
By Stewart Eisenhart, Emergo Group Health Canada, Canada’s medical device market regulator, has begun accepting some clinical trial-related information from sponsors via electronic submissions. 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 MassDevice.com or its […]
Building the Engineering Team You Need
A key challenge facing business and engineering leaders today is talent acquisition and retention. Unemployment is at a nearly 50-year low at 3.7 percent, and if you focus on engineering specifically, the rate is a meager 1.8 percent. In a recent Congressional Research Service report, it was estimated that science and engineering jobs will increase […]
Supporting regulatory affairs departments to address clinical requirements under new MDR
By Dietmar Falke and Jaap Laufer, Emergo Group The May 25, 2020 MDR deadline is approaching rapidly, and by now many medical device manufacturers are aware that the MDR requires the proactive collection of post-marketing clinical follow-up (PMCF) data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
ResMed settles kickback allegations for $37.5 million
This article has been updated with comments from ResMed. ResMed (NYSE:RMD) has agreed to pay more than $37.5 million to settle five whistleblower lawsuits claiming the company paid kickbacks to doctors, sleep labs and medical equipment suppliers to obtain customer referrals, according to the U.S. Department of Justice. Federal prosecutors alleged that San Diego-based ResMed: […]
FDA recognizes latest ISO 14971 as medical device consensus standard
By Mark Leimbeck and Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14071 risk management standard for medical devices and IVD products. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
Senate confirms Dr. Stephen Hahn to lead FDA
The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer […]
