Dear colleagues, hello! 👋
For the past few months, I have been curating a comprehensive list of medical device approvals, clearances and De Novos on a monthly basis.
I am simply amazed by the continued pace of innovation in our industry.
I would like to take a moment to celebrate this and thank everyone who works so hard in our industry.
✅ Just look at the number of number of devices approved/cleared by the FDA during the month of December 2023:
1️⃣ An external mechanical stimulator to relive nasal congestion (De Novo).
2️⃣ A software to analyze GI capsule images obtained during endoscopy (De Novo).
3️⃣ An app to measure body temperature using a smartphone (De Novo).
4️⃣ A software to predict liver tissue response after an ablation procedure for post-treatment (De Novo)
5️⃣ A pulse field ablation system for treatment of atrial fibrillation (PMA, Original, P230017).
6️⃣ A DNA-based assay and sample collection kit for detection of opioid use disorder (PMA, Original, P230032).
7️⃣ A portfolio of stents for customized treatment of chronic venous insufficiency (CVI) (PMA, Original, P230021).
8️⃣ An occluder implant for closure of secundum type atrial septum defect (PMA, Original, P200032).
9️⃣ A total of 312 devices were cleared through the 510(k) process during December 2023. Days to FDA decision ranged from 1 to 649 with a median of 128 days. Top 5 medical specialties were Radiology (RA), Orthopedic (OR), Cardiovascular (CV), General & Plastic Surgery (SU), and Dental (DE) accounting for 60% (186/312) of devices cleared.
If you would like to learn more, including warning letters and recall announcements, click on the graphic below
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Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
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