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Category: FDA

BiVacor Earns FDA Breakthrough Status for Total Artificial Heart
Hyperfine’s AI-Powered Portable MRI System Gains FDA Clearance
AnX Robotica Secures FDA Clearance for Next-Gen GI Motility Capsule
Olympus Wins FDA Nod for Advanced Endoscopes
Medtronic’s Nellcor Pulse Oximetry Joins FDA STeP
Distalmotion Wins FDA Nod for Gallbladder Surgery
FDA Grants Breakthrough Status to Prevencio’s AI CAD Blood Test
FDA Seeks Stronger Heart Risk Warnings for COVID-19 Vaccines
FDA Clears Trax Surgical’s Linkt Nitinol Compression Staple System
Stryker Gains FDA Clearance for OptaBlate Basivertebral Nerve Ablation System
BiVacor Earns FDA Breakthrough Status for Total Artificial Heart
BiVacor Earns FDA Breakthrough Status for Total Artificial Heart
BiVacor has received FDA breakthrough device designation for its Total Artificial Heart (TAH) system, designed for adults with severe biventricular or univentricular heart failure where traditional treatments fall short. Key features of the BiVacor...
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Hyperfine’s AI-Powered Portable MRI System Gains FDA Clearance
AnX Robotica Secures FDA Clearance for Next-Gen GI Motility Capsule
Olympus Wins FDA Nod for Advanced Endoscopes
Medtronic’s Nellcor Pulse Oximetry Joins FDA STeP
Distalmotion Wins FDA Nod for Gallbladder Surgery
FDA Grants Breakthrough Status to Prevencio’s AI CAD Blood Test
FDA Seeks Stronger Heart Risk Warnings for COVID-19 Vaccines
FDA Clears Trax Surgical’s Linkt Nitinol Compression Staple System
Stryker Gains FDA Clearance for OptaBlate Basivertebral Nerve Ablation System

More on the topic you are reading

BiVacor Earns FDA Breakthrough Status for Total Artificial Heart
BiVacor Earns FDA Breakthrough Status for Total Artificial Heart
BiVacor has received FDA breakthrough device designation for its...
Hyperfine’s AI-Powered Portable MRI System Gains FDA Clearance
Hyperfine’s AI-Powered Portable MRI System Gains FDA Clearance
Hyperfine has secured FDA clearance for its next-generation Swoop...
AnX Robotica Secures FDA Clearance for Next-Gen GI Motility Capsule
AnX Robotica Secures FDA Clearance for Next-Gen GI Motility Capsule
AnX Robotica announced FDA 510(k) clearance for its MotiliCap...
Olympus Wins FDA Nod for Advanced Endoscopes
Olympus Wins FDA Nod for Advanced Endoscopes
Olympus has received FDA 510(k) clearance for its EZ1500...
Medtronic’s Nellcor Pulse Oximetry Joins FDA STeP
Medtronic’s Nellcor Pulse Oximetry Joins FDA STeP
Medtronic’s next-generation Nellcor pulse oximetry technology has been accepted...
Distalmotion Wins FDA Nod for Gallbladder Surgery
Distalmotion Wins FDA Nod for Gallbladder Surgery
Distalmotion has received FDA 510(k) clearance for using its...
FDA Grants Breakthrough Status to Prevencio’s AI CAD Blood Test
FDA Grants Breakthrough Status to Prevencio’s AI CAD Blood Test
Prevencio, a Washington-based healthcare company, has received the FDA...
FDA Seeks Stronger Heart Risk Warnings for COVID-19 Vaccines
FDA Seeks Stronger Heart Risk Warnings for COVID-19 Vaccines
The FDA is requesting Pfizer and Moderna update warning...
FDA Clears Trax Surgical’s Linkt Nitinol Compression Staple System
FDA Clears Trax Surgical’s Linkt Nitinol Compression Staple System
Trax Surgical announced FDA 510(k) clearance for its Linkt...
Stryker Gains FDA Clearance for OptaBlate Basivertebral Nerve Ablation System
Stryker Gains FDA Clearance for OptaBlate Basivertebral Nerve Ablation System
Stryker announced FDA 510(k) clearance for its OptaBlate BVN...
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