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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

March 12, 2020

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Money-financing

Sientra reports record quarter as COVID-19 affects guidance

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
Coronavirus Covid-19 DNA

Inovio snags $5M Gates Foundation grant for COVID-19 vaccine delivery device

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

JOBS on-ramp for smaller companies just got longer

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
FDA-yellow-dice.png

FDA calls out elimination of re-review in third-party 510(k) final guidance

Medical devices are known to be iterative, but so are FDA guidances, and the 2018 draft guidance for third-party review of 510(k) applications was the second such document in two years.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
3-21-Ausculsciences-CAD-det.png

AI-powered sensors a step up on treadmill exercise test for detecting CAD

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
3-21-QUANTUM-SURGICAL-robot.png

Quantum Surgical raises $2.25M for its robotic liver cancer platform

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

Appointments and advancements for March 12, 2020

New hires and promotions in the med-tech industry, including: Iradimed, Sonendo. Read More

Financings for March 12, 2020

Med-tech firms raising money in public or private financings, including: Globus Medical. Read More

Other news to note for March 12, 2020

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advaite, Arjo, Bioness, Crscube, Genetron, Hge Health, Janssen Biotech, Johnson & Johnson, Motus GI, Philips, Precheck Health, Pulsara, Respircare, Seating Matters, Sectra, Sentinel Diagnostics, Suning International, Supercom, Techsee, Theralight, Thermo Fisher Scientific, Twist Bioscience, Viveve Medical, Zeptometrix. Read More

Regulatory actions for March 12, 2020

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

Regulatory front for March 12, 2020

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Transmedics. Read More

BioWorld MedTech’s Diagnostics Extra for March 12, 2020

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

BioWorld MedTech Patent Highlights: Week 10

BioWorld MedTech presents Patent Highlights, an excerpt of the most important med-tech patents from this week's Cortellis Patents Gazette. Read More

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