ICU Medical (NSDQ:ICUI) this week said it appointed Brian Bonnell as chief financial officer, effective March 3. Bonnell replaces Scott Lamb who announced his intent to retire after filing the company’s annual report. Lamb will continue to serve as an advisor to the company during a transition period ending April 3. Bonnell has served as ICU […]
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 […]
iRhythm Technologies beats on revenue, misses on earnings in Q4 results
iRhythm Technologies (NSDQ:IRTC) posted fourth-quarter results today that beat the revenue consensus on Wall Street but missed on earnings. The San Francisco-based company reported losses of $17.3 million, or -65¢ per share, on sales of $59.1 million for the three months ended Dec. 31, 2019, for a bottom-line sales growth of 41.5% compared with Q4 2018. […]
ICU Medical posts wider-than-forecast losses in Q4 results
ICU Medical (NSDQ:ICUI) posted fourth-quarter results today that beat the revenue consensus on Wall Street but missed on earnings. The San Clemente, Calif.-based company reported profits of $20.6 million, or 96¢ per share, on sales of $315.5 million for the three months ended Dec. 31, 2019, for a bottom-line sales loss of -7.3% compared with Q4 […]
Alphatec to purchase EOS Imaging
Alphatec (NSDQ:ATEC) today said it would acquire EOS Imaging for $88 million, plus debt retirement of $33.9 million. EOS Imaging develops rapid, low dose, biplanar, full-body imaging and 3D modeling capabilities. It captures a calibrated, full-body image in a standing position, offering precise measurement of anatomical angles and dimensions. “This is a monumental transaction for ATEC,” […]
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.
Cantel Medical appoints chief growth officer
Cantel Medical (NYSE:CMD) today said it appointed Seth Yellin as executive VP and chief growth officer. In the newly created role, Yellin will be responsible for identifying and supporting both organic and inorganic initiatives to drive the company’s growth objectives. He will lead the development of the overall corporate strategy, as well as Cantel Medical’s acquisition […]
Iradimed appoints new VP of regulatory affairs and quality assurance
Iradimed (NSDQ:IRMD) this week said it appointed Steven Kachelmeyer as VP of regulatory affairs and quality assurance, effective March 10. Kachelmeyer will report directly to president and CEO Leslie McDonnell. He replaces Francis Casey who announced his intention to retire, effective June 30. “Under Fran’s leadership, Iradimed gained regulatory approvals in the U.S., Europe and many […]
Staar Surgical beats on earnings, meets revenue in Q4 results
Staar Surgical (NSDQ:STAA) posted fourth-quarter results that beat the consensus forecast on Wall Street. The Monrovia, Calif.-based company reported profits of $6.4 million, or 14¢ per share, on sales of $38.9 million for the three months ended Jan. 3, 2020, for a bottom-line gain of 482% sales growth of 24.7% compared with Q4 2018. Adjusted to […]
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 […]
Nevro shares rise with Street-beating Q4 results
Nevro (NYSE:NVRO) reported fourth-quarter results today that beat the consensus forecast on Wall Street. The Redwood City, Calif.-based company reported losses of -$13.7 million, or -44¢ per share, on sales of $114.3 million for the three months ended Dec. 31, 2019, for sales growth of 5.9% compared with Q4 2018. Earnings per share were -44¢, 19¢ […]