Posts tagged 510(k)
Echelon starts Profound Medical at buy

Echelon Wealth Partners initiated coverage of Profound Medical (OTCQX:PRFMF; TSXV:PRN) with a “buy” rating and one-year price target of $4. The stock closed at 78 cents on March 14.

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Arch advances 510(k) filing for AC5 hemostat

Arch Therapeutics (OTCQB:ARTH) announced that the 510(k) filing for external use of the AC5 Topical Hemostatic device would be advanced to mid-2017 from the previously announced target of late 2017.

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FDA rejects TransEnterix SurgiBot submission

The FDA has advised TransEnterix (NYSE MKT:TRXC) that its SurgiBot System does not meet the criteria for substantial equivalence based on the data and information submitted by the company in its 510(k) submission.

“The FDA’s decision is extremely disappointing. We are in the process of reviewing all aspects of the FDA’s communication,” Todd Pope, president and CEO, said in a statement.

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TransEnterix updates SurgiBot FDA submission

TransEnterix (NYSE MKT:TRXC) has received an update from the FDA on the status of the 510(k) submission for its robotics SurgiBot system to improve minimally invasive surgery.

The FDA advised the company that it has not yet concluded the review of the 510(k) submission and provided an update on the status of the filing.

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