Sientra Inc., of Santa Barbara, Calif., reported gains in both its breast products and Miradry segments during its fourth-quarter earnings call after the close of the market March 11. For his part, CEO Jeff Nugent noted that the company had experienced record total net sales in the fourth quarter of $23.2 million, representing growth of 22% year-on-year. However, the company provided full-year 2020 guidance for 12% to 17% growth, which William Blair’s Margaret Kaczor said was below her organization’s 22% estimate, “though the shortfall is largely a result of negative impacts from COVID-19.” Read More
As the COVID-19 strain of coronavirus continues to spread around the globe, companies are scrambling to develop effective diagnostics and vaccines to contain the outbreak and reduce future threats. Among those is Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., which has been awarded a $5 million grant from the Bill & Melinda Gates Foundation to speed testing and scale of smart delivery device for its COVID-19 vaccine candidate. Read More
The U.S. Securities and Exchange Commission (SEC) Thursday extended the public on-ramp for small companies that take longer than five years to generate $100 million in annual revenue, as well as some of the business development companies that invest in them. Read More
Medical devices are known to be iterative, but so are FDA guidances, and the 2018 draft guidance for third-party review of 510(k) applications was the second such document in two years. The 2020 final guidance made another adjustment or two based on feedback from industry, including a specific note that the intent of the guidance is to eliminate any need for routine FDA re-review of 510(k)s reviewed by third parties. Read More
TORONTO – Complain to your doctor about shortness of breath, chest pain or a rapid or irregular heartbeat and chances are you’ll end up on a treadmill to check for the presence of coronary artery disease or CAD. The conventional treadmill stress test is a time-consuming process that could change with patented, AI-driven sensor technology developed by Ottawa, Ontario-based Ausculsciences Inc. and bankrolled by US$10 million from investors anxious to see the CAD-det System approved for sale by the end of the year. Read More
PARIS – Quantum Surgical SAS, of Montpellier, France, has been awarded development aid amounting to $2.25 million in grants and repayable loans from Bpifrance bank, as part of the French Deeptech program. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Behold.ai, Conextions, Fluidda, Ossio, Sumitomo Heavy Industries. Read More
Keeping you up to date on recent developments in diagnostics, including: Preventing birth defects; Full-waveform inversion for brain imaging; From junk to noncoding to coding; An efficient strategy for Legionella detection. Read More
