#fda letter

[pknoepfl]

Kimera Labs FDA letter cites exosomes for COVID-19, more issues

Kimera Labs FDA letter cites exosomes for COVID-19, more issues

A firm called Kimera labs just received an untitled letter from the FDA. The firm has been supplying non-FDA-approved exosomes to various customers including at least one stem cell clinic without sparking any obvious action from the agency, but on April 10th that changed with the letter, which in my view is quite serious. What sparked it?

My sense is that a major trigger was Kimera Labs being…

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[regulatorydoctor-blog]

FDA Sent Letters to Three Firms for Lack of Marketing Clearances

FDA Sent Letters to Three Firms for Lack of Marketing Clearances

 The United States Food and Drug Administration Center for Office of In Vitro Diagnostics and Radiological Health (OIR) | Center for Devices and Radiological Health (CDRH)

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November 3, 2015

The FDA/OIR/CDRH sent letters to three firms for lack of marketing clearances

Letter to the DNA-Cardiocheck, Inc.

It has come to our attention that you are currently marketing a…

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[medical-device-news]

FDA Dings Philips On InnerCool RTx Component Recall

The FDA issues a warning letter to Philips over its late notification for the recall of a component of its InnerCool RTx temperature control device.

The FDA dinged Philips (NYSE:PHG) for tardiness in its notification of the recall of a component for…

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[medical-device-news]

MiMedx Lands a Date With the FDA

MiMedx to meet with FDA on October 28t

MARIETTA, Ga., Oct. 17, 2013 /PRNewswire/ – MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human…

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[medical-device-news]

FDA Slams Paradigm Insulin Pump by Medtronic Over Quality Issues

FDA regulators handed Medtronic a warning letter over issues associated with its Paradigm-branded insulin infusion pumps. This comes on top of a Class I recall this past summer over a faulty part in the infusion pump system.

On September 19th, regulators…

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[medical-device-news]

Antibiotics Withdrawn From the Market 3x More Often Than Other Drugs

More than 40 percent of the antibiotics released between 1980 and 2009 were withdrawn from the market for safety concerns, lack of effectiveness compared to existing drugs, and weak sales, according to the first study to evaluate the status of 30 years of…

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[medical-device-news]

Intuitive Surgical Says Robot Surgery Complications Study is "Misleading"

Intuitive Surgical cries foul on a Johns Hopkins study that questions whether adverse events associated with robot-assisted surgical systems are properly reported to the FDA.

Robot-assisted surgical systems maker Intuitive Surgical (NSDQ:ISRG) called out…

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[medical-device-news]

Defect Leads Siemens to Recall 78,000 MicroScan Panels

(Reuters) – Germany’s Siemens recalled 78,020 microbiology testing panels in the United States as they are reporting false results, U.S. health regulators said.

The defect found in certain MicroScan panels may lead to treatment of patients with…

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