FDA clears new medical watch, considers empagliflozin for CKD and much more

The US Food and Drug Administration (FDA) started 2023 with a tumultuous January. The agency has approved new transcatheter aortic valve replacement from Abbott, among others, and announced two major recalls.

However, those news programs are only the beginning. Here’s a review of other key FDA-related stories that have affected heart disease since the regulatory release last Dec. 22:

1. FDA Issues Three Indications for CardiacSense Medical Watches

CardiacSense, an Israel-based healthcare technology company It has received FDA approval for the CSF-3 medical watch. and measurements of oxygen saturation of arterial hemoglobin.

Eldad Shemesh, founder and CEO of CardiacSense, said in a prepared statement: “We have developed proprietary hardware. This includes a new motion object sensor. which identifies and cancels animated objects This results in us having a pure biometric signal for accurate monitoring of vital signs.”

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CardiacSense also plans to submit more information to the FDA related to the CSF-3 watch’s ability to detect arrhythmias and track users’ breathing rate and blood pressure.

The CSF-3 watch previously received CE mark approval in Europe for four indications, including continuous monitoring of atrial fibrillation (AFib) and B2B-beat pulse rate using phototherapy. Topplethysmography

According to the statement, CardiacSense hopes to conclude an agreement with a commercial partner in the US and launch it in the US by the end of 2023.

2. FDA Allows MedAlliance to Approval for a Fourth Investigation Device Exemption This time for the study of coronary artery lesions.

MedAlliance, a Swiss-based healthcare technology recently acquired by Cordis, has received FDA-approved Investigative Device Exemption (IDE) approval to kick off its review. New Clinical Trial Focusing on SELUTION SLR’s Drug Eradication Balloon (DEB) Treatment of Coronary Artery Lesions

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This is the company’s fourth IDE approval for DEB so far. Registration in this newly approved trial is expected to begin in the first few months of 2023.

Ron Waksman, cardiologist Professor of Cardiology at Georgetown University said director of cardiovascular research at MedStar Health and Vascular Institute and president. “The SELUTION SLR coronary de novo study is the first in the United States. and will provide important information on the efficacy and safety of sirolimus elimination balloons. This is an effective alternative to the use of drug-eluting stents. without leaving anything behind the coronary artery after skin puncture Intervention and elimination of stent stenosis and associated complications.”

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“Coronary artery lesions are the most likely prospect for the use of DEB’s: the data clearly show that DES does not work well in small blood vessels. Long or bifurcated lesions or in patients with diabetes or at high risk for bleeding complications,” added MedAlliance President and CEO Jeffrey B. Jump.

The SELUTION SLR DEB has received CE mark approval for the treatment of peripheral vascular and coronary artery disease.


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