devices

FDA issues final rule removing certain software from medical device regulations
FDA issues final rule removing certain software from medical device regulations
RAPS.org
devices
21st Century Cures Act
FDA
software
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When is a drug really a device? Court knocks down FDA appeal in trying to sort that grey area
When is a drug really a device? Court knocks down FDA appeal in trying to sort that grey area
Endpoints
devices
FDA
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Virtual Surgical to Go Public Through Merger with D8 Holdings
Virtual Surgical to Go Public Through Merger with D8 Holdings
Medical Devices and Diagnostics Industry
Virtual Surgical
D8 Holdings
M&A
devices
robotic surgery
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FDA updates on ASCA pilot, lists accredited test labs
FDA updates on ASCA pilot, lists accredited test labs
RAPS.org
FDA
ASCA
devices
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6 medtechs to watch when earnings kick off next week
6 medtechs to watch when earnings kick off next week
Medtech Dive
earnings
devices
Abbott Labs
Edwards Lifesciences
Intuitive Surgical
JNJ
Roche
Quest Diagnostics
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Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance
Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance
Medtech Dive
Medtronic
Colonoscopy
devices
FDA
artificial intelligence
Cosmo Pharmaceuticals
GI Genius
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Orthopaedic surgeons see slow volume recovery from COVID-19, tip Stryker to gain in poll
Orthopaedic surgeons see slow volume recovery from COVID-19, tip Stryker to gain in poll
Medtech Dive
Orthopedic
Smith & Nephew
Stryker
COVID-19
pandemic
devices
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Hologic Locks Down 4th M&A Target This Year
Hologic Locks Down 4th M&A Target This Year
Medical Devices and Diagnostics Industry
Hologic
devices
M&A
Mobidiag Oy
molecular diagostics
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J&J Vision and Menicon Tackle Myopia with Contact Lens Collaboration
J&J Vision and Menicon Tackle Myopia with Contact Lens Collaboration
Medical Devices and Diagnostics Industry
JNJ
Menicon
myopia
contact lens
Japan
devices
Medtech
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Suit alleging Medtronic misled FDA over spine fusion can proceed, appeals court says
Suit alleging Medtronic misled FDA over spine fusion can proceed, appeals court says
Medtech Dive
Medtronic
devices
spinal fusion
FDA
whistleblower lawsuits
False Claims Act
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Medical device firms’ payments to doctors far outstripped those from pharma, study shows
Medical device firms’ payments to doctors far outstripped those from pharma, study shows
Stat
devices
physicians
physician payments
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First Non-Surgical Heart Valve Wins FDA Approval for Severe Pulmonary Valve Regurgitation
First Non-Surgical Heart Valve Wins FDA Approval for Severe Pulmonary Valve Regurgitation
Xtalks
devices
FDA
Medtronic
Harmony Transcatheter Pulmonary Valve
pulmonary valve regurgitation
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Nevro touts data supporting use of Senza system to treat diabetic neuropathy pain
Nevro touts data supporting use of Senza system to treat diabetic neuropathy pain
Mass Device
devices
Nevro
Senza
diabetic neuropathy
chronic pain
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Helius Medical’s device gets FDA all clear to stimulate the brain via the tongue
Helius Medical’s device gets FDA all clear to stimulate the brain via the tongue
MedCity News
Helius
devices
FDA
brain stimulation
multiple sclerosis
MS
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FDA links certain breast reconstruction devices to risk of complications
FDA links certain breast reconstruction devices to risk of complications
Medtech Dive
devices
FDA
breast implants
breast reconstruction
Becton Dickinson
MTF Biologics
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How a Near-Death Experience Influenced a Medtech CEO's Career Path
How a Near-Death Experience Influenced a Medtech CEO's Career Path
Medical Devices and Diagnostics Industry
devices
Medtech
sepsis
John Sperzel
T2 Biosystems
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Merck sets up $240M Alydia Health buyout to beef up its future Organon women's health spinout
Merck sets up $240M Alydia Health buyout to beef up its future Organon women's health spinout
Fierce Biotech
Merck
Alydia Health
Organon
devices
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Analysts tip surgeries to rebound. Rising COVID-19 cases threaten those forecasts
Analysts tip surgeries to rebound. Rising COVID-19 cases threaten those forecasts
Medtech Dive
elective surgery
devices
Medtech
pandemic
COVID-19
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Medtronic's Harmony pulmonary valve wins FDA approval
Medtronic's Harmony pulmonary valve wins FDA approval
Medtech Dive
Medtronic
devices
pulmonary valves
FDA
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New Medtronic Implant a 'World First' for Congenital Heart Disease
New Medtronic Implant a 'World First' for Congenital Heart Disease
Medical Devices and Diagnostics Industry
Medtronic
devices
FDA
pulmonary valve reguritation
cogenital heart disease
cardiac implants
pediatric
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