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FDA – Medwire
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Category: FDA

Dexcom Taps Jake Leach as Next CEO
FDA Approves First Neuroimmune Device for Arthritis
EvoEndo Gains FDA Nod for All-Ages Gastroscope
Medtronic Advances Toward FDA Approval for Infuse Bone Graft in...
Stereotaxis Wins FDA Clearance for Magic Sweep Robotic EP Mapping...
FDA Warns on Baxter Infusion Pump Safety
Imperative Care Gains FDA Clearance for Zoom 7X Catheter
FDA Grants IDE for UroMems’ Smart Implant Study in Male...
FDA Expands Watchman Device Use for Post-Ablation
FDA Announces Multiple Class I Recalls for Edwards Lifesciences Cardiac...
Dexcom Taps Jake Leach as Next CEO
Dexcom Taps Jake Leach as Next CEO
Dexcom has announced that President and COO Jake Leach will become CEO on January 1, 2026, succeeding longtime leader Kevin Sayer. Leach, a 21-year Dexcom veteran, has been instrumental in developing multiple generations of...
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FDA Approves First Neuroimmune Device for Arthritis
EvoEndo Gains FDA Nod for All-Ages Gastroscope
Medtronic Advances Toward FDA Approval for Infuse Bone Graft in TLIF
Stereotaxis Wins FDA Clearance for Magic Sweep Robotic EP Mapping Catheter
FDA Warns on Baxter Infusion Pump Safety
Imperative Care Gains FDA Clearance for Zoom 7X Catheter
FDA Grants IDE for UroMems’ Smart Implant Study in Male SUI
FDA Expands Watchman Device Use for Post-Ablation
FDA Announces Multiple Class I Recalls for Edwards Lifesciences Cardiac Cannulae

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Dexcom Taps Jake Leach as Next CEO
Dexcom Taps Jake Leach as Next CEO
Dexcom has announced that President and COO Jake Leach...
FDA Approves First Neuroimmune Device for Arthritis
FDA Approves First Neuroimmune Device for Arthritis
SetPoint Medical has received FDA approval for its neuroimmune...
EvoEndo Gains FDA Nod for All-Ages Gastroscope
EvoEndo Gains FDA Nod for All-Ages Gastroscope
EvoEndo has received expanded FDA clearance for its Model...
Medtronic Advances Toward FDA Approval for Infuse Bone Graft in TLIF
Medtronic Advances Toward FDA Approval for Infuse Bone Graft in...
Medtronic (NYSE: MDT) announced a key milestone in its...
Stereotaxis Wins FDA Clearance for Magic Sweep Robotic EP Mapping Catheter
Stereotaxis Wins FDA Clearance for Magic Sweep Robotic EP Mapping...
Stereotaxis (NYSE: STXS) received FDA 510(k) clearance for its...
FDA Warns on Baxter Infusion Pump Safety
FDA Warns on Baxter Infusion Pump Safety
The FDA has issued a safety alert regarding Baxter’s...
Imperative Care Gains FDA Clearance for Zoom 7X Catheter
Imperative Care Gains FDA Clearance for Zoom 7X Catheter
Imperative Care has received FDA 510(k) clearance for its...
FDA Grants IDE for UroMems’ Smart Implant Study in Male SUI
FDA Grants IDE for UroMems’ Smart Implant Study in Male...
UroMems has received FDA investigational device exemption (IDE) approval...
FDA Expands Watchman Device Use for Post-Ablation
FDA Expands Watchman Device Use for Post-Ablation
Boston Scientific has secured expanded FDA approval for its...
FDA Announces Multiple Class I Recalls for Edwards Lifesciences Cardiac Cannulae
FDA Announces Multiple Class I Recalls for Edwards Lifesciences Cardiac...
Edwards Lifesciences has recalled over 61,000 units of its...
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