March 2, 2021
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Top Story
Molecular diagnostic firm Diagenode has been bought by Hologic in a deal worth $159 million. "We are excited to put our strong cash flow to work to acquire Diagenode and further strengthen our diagnostics business," said Hologic President and CEO Steve MacMillan.
Full Story: MassDevice (Boston) (3/1) 
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Influence of COVID-19 and Moving Forward
COVID-19 has dramatically impacted the medical industry and has led to changes in trends that will have long-lasting repercussions. Read how the medical and public health sectors have adapted to the pandemic and how businesses should consider meeting those healthcare needs in the future. Learn more
Business & Market Trends
OraSure Technologies generated $62.9 million in revenues during its fiscal fourth quarter, up 27% from the previous year, due to demand for molecular sample collection devices.
Full Story: GenomeWeb Daily News (free registration) (3/1) 
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Science & Health
Researchers from Rice University have developed a microfluidic chip the size of a stamp that can be plugged into a cellphone and can detect COVID-19 within 55 minutes.
Full Story: Medical Device & Diagnostic Industry online (3/1) 
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The University of California at San Francisco and the University of California at Los Angeles were granted FDA approval to use the Prostate Specific Membrane Antigen PET Scan, and Dr. Peter Carroll at UCSF calls it a "game changer" that will help provide more precise treatment plans for patients with prostate cancer. Nuclear medicine physician Dr. Thomas Hope at UCSF, who helped validate the PSMA PET Scan, said it allows physicians to more accurately and easily localize the disease.
Full Story: KPIX-TV (San Francisco) (2/25) 
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A study in Physics in Medicine & Biology found the use of deep-learning noise-reduction technology led to F-18 FDG dose reduction in cardiac PET images of ischemic heart disease patients without losing diagnostic accuracy. "A reduction to one hundredth of the dose is possible with quantitative clinical metrics comparable to that obtained with a full dose," researchers wrote.
Full Story: Physics World (3/1) 
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Emerging Technologies
Vela Diagnostics has developed the ViroKey SARS-CoV-2 ID RT-PCR Test, which can detect COVID-19 variants like B.1.351 from South Africa, P.1 from Brazil and B.1.1.7 from the UK. The company has also developed the ViroKey SQ FLEX SARS-CoV-2 Genotyping Assay.
Full Story: Verdict Medical Devices (UK) (3/1) 
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Government & Regulatory
The FDA has given emergency use authorization to Quidel for its QuickVue At-Home COVID-19 test.
Full Story: MassDevice (Boston) (3/1) 
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The FDA has given emergency use authorization to the University of Illinois for its covidSHIELD, a saliva-based COVID-19 test.
Full Story: Chicago Tribune (tiered subscription model) (3/1) 
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Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay has been reissued emergency use authorization by the FDA, allowing it to be used with the Azova COVID-19 Test Collection Kit.
Full Story: GenomeWeb Daily News (free registration) (3/1) 
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Memic Innovative Surgery has received De Novo approval for its Hominis Surgical System, a minimally invasive robotically assisted surgical device used during transvaginal hysterectomy.
Full Story: FDAnews (3/2) 
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AdvaMed Events and Education
Registration for The Digital MedTech Conference is open! Taking place virtually on May 6, The Digital MedTech Conference is a great opportunity to gain insights from leading industry experts and partake in discussion about current and future challenges, opportunities and trends in the digital health and medical device sectors. Learn more.
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This four-part virtual program will help you and your team mitigate the burden of compliance. These sessions will provide you with a thorough understanding of the compliance framework, as well as practical approaches for addressing challenges and effectively managing compliance. Register for two or more sessions and receive 20% off with the code BUNDLEIT. See more details.
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