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Icentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT®

Legacy MEDSearch

announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. The FDA clearance opens the door to the world’s largest medical device market. Icentia Inc., “This approval marks a key milestone for our company.

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Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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annalise.ai appoints proven global healthcare leader as CEO, officially launches US team following FDA clearances

Legacy MEDSearch

annalise.ai, the global radiology AI company with rapidly growing presence in Asia- Pacific, Europe and the United Kingdom, today announced the appointment of accomplished healthcare technology executives Lakshmi Gudapakkam as Chief Executive Officer and clinical strategist Dr Rick Abramson as Chief Medical Officer.

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Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance

Legacy MEDSearch

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. The clearance allows the company to market and sell the device to more pharmaceutical companies, healthcare organizations, and academic institutions across the country, expanding access to a simple and virtually painless blood collection experience.

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Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging System

Legacy MEDSearch

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. The designation allows a collaborative and streamlined review pathway with FDA so the Orlucent technology can get to the market faster. Orlucent, Inc., president of Orlucent.

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Selling to Physicians from a Physician’s Perspective

MedCepts

Therefore, the first thing to consider when selling to physicians is that your product, device or service is safe. In addition, it needs to be approved either by the FDA or other respective authorizing body. Physicians Seek Evidence based information. When selling to physicians, yours answers should preferably be evidence based.

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MedWand Solutions Receives FDA 510k Clearance

Legacy MEDSearch

Food and Drug Administration (FDA) has granted 510(k) clearance to the MedWand,” shared MedWand CEO and Co-Founder, Robert Rose. “As MedWand Mobile Clinic – Designed for physician or home visits and remote patient monitoring applications. To request a demo today visit www.medwand.com. “I I am happy to share that the U.S.

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