April 22, 2021
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Top Story
The FDA has given its approval to Medtronic for its Pipeline Flex embolization device with Shield Technology. "In addition to addressing material thrombogenicity, Shield Technology improves device performance by reducing the force required for both delivery and resheathing of the device. We believe that Shield Technology opens up a new range of options for physicians to continue to achieve improved patient outcomes," said Dan Volz, Medtronic's neurovascular business president.
Full Story: MassDevice (Boston) (4/21) 
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One Year Later: The PREP Act and COVID-19
In this special edition webinar series, Medmarc defense panel member, Jordan Lipp, Managing Member, Childs McCune, will lead an updated discussion about the PREP Act and COVID-19 a year later and its implications on the life sciences industry. View On-Demand
Business & Market Trends
Roche generated $16.3 billion in sales during its fiscal first quarter due to demand for COVID-19 products.
Full Story: Reuters (4/21) 
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Intuitive Surgical generated $1.3 billion in sales and $435.2 million in profits during the quarter that ended March 31. "In the quarter, we saw a healthy recovery of surgery and use of our products. Strong capital placements continued in Q1 2021 and utilization of installed systems increased through the quarter, indicating a need by our customers to return to surgery," CEO Gary Guthart said.
Full Story: MassDevice (Boston) (4/21) 
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Science & Health
Data from Medtronic's study of its IN.PACT AV drug-coated balloon showed that, for two years, it had a sustained and superior effectiveness in treating arteriovenous fistulae lesions in patients with end-stage renal disease, compared with standard percutaneous transluminal angioplasty.
Full Story: Medical Device Network (UK) (4/21) 
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A study in Radiology found patients with HIV who were not known to have cardiovascular disease have an up three times greater noncalcified plaque burden compared with a control group without HIV. The findings, based on the coronary CT angiography results of 265 patients, suggested that "coronary CT angiography interpretation in people living with HIV should probably include quantification of coronary plaque by subtypes to allow better cardiovascular risk stratification," said study author Dr. Carl Chartrand-Lefebvre.
Full Story: Health Imaging (4/20),  AuntMinnie (free registration) (4/20) 
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Emerging Technologies
The WaveForm TO transforaminal lumbar interbody fusion system has been released by SeaSpine on a limited basis.
Full Story: Becker's Spine Review (4/20) 
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Government & Regulatory
An amendment to streamline the authorization process for pooled molecular coronavirus testing was issued by the FDA on Tuesday. The change applies to anterior nasal respiratory pooled specimens and tests used at least once a week within serial testing programs.
Full Story: 360Dx (tiered subscription model) (4/21) 
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The FDA has given 510(k) clearance to Johnson & Johnson Vision for its Veritas vision system, a phacoemulsification machine.
Full Story: MassDevice (Boston) (4/21) 
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European regulators have given CE mark approval to DiaSorin for its LIAISON Quick Detect COVID TrimericS Ab test, which can deliver results within 10 minutes.
Full Story: FDAnews (4/22) 
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European regulators have given CE mark approval to SenseTime for its SenseCare-Chest DR Pro, an artificial intelligence-powered program for the fast triage of chest X-ray scans.
Full Story: FDAnews (4/22) 
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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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