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Exploring Market Drivers in the Latin America Digital Dentistry Sector
nicolas.clary . May 15, 2024
The digital dentistry landscape in Latin America is evolving, spurred by significant market drivers across Brazil, Colombia, and Mexico. This…
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MDCG 2024-6, 7, 8 and 9 – Preliminary (re-)assessment review form templates
nicolas.clary . May 15, 2024
MDCG 2024-6 Preliminary assessment review (PAR) form template (MDR) May 2024 MDCG 2024-7 Preliminary assessment review (PAR) form template (IVDR) …
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Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff
nicolas.clary . May 15, 2024
The HeartMate 3 Left Ventricular Assist System may allow blood to leak out or air to enter the system during…
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Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff
nicolas.clary . May 15, 2024
The HeartMate 3 Left Ventricular Assist System may allow blood to leak out or air to enter the system during…
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Top Procedure Performed Within the US Urological Devices Market in 2023
nicolas.clary . May 13, 2024
Throughout 2023, the MedTech space has seen significant activity in the realm of urological procedures, driven predominantly by an aging…
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Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication
nicolas.clary . May 13, 2024
The FDA issues alert about risk of false results with Cue Health’s COVID-19 Tests due to modifications made without FDA…
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Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction
nicolas.clary . May 13, 2024
Philips Respironics is recalling their Trilogy Evo ventilators due to a software-related possible power malfunction, leading to a sudden loss…
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Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band
nicolas.clary . May 10, 2024
Route 92 Medical is recalling certain products that include Tenzing 7 Delivery Catheters due to instances of the catheter tip…
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MEGADYNE™ Initiates Global Discontinuation and Voluntary Recall of MEGA SOFT™ Pediatric Patient Return Electrode
nicolas.clary . May 10, 2024
MEGADYNE™ is initiating a voluntary recall of all MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes. The product is being removed…
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Safety and Quality Concerns with Getinge Cardiovascular Devices – Letter to Health Care Providers
nicolas.clary . May 8, 2024
Health care providers and facilities should begin to transition away from these devices and seek alternatives.
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