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Approvals

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Novel Medical-Imaging Isotope Platform Nabs US FDA Approval

The RadioGenix System from NorthStar Medical Radioisotopes will be the first system to make the most common radioactive isotope used in imaging in the US in 30 years, using an innovative process that avoids the need for enriched uranium.

Medical Device BioPharmaceutical Approvals
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First Concussion Blood Test Leverages De Novo, Breakthrough Pathways

The Banyan Brain Trauma Indicator is the first blood test for detecting concussions in adults to reach the US market and the second device to emerge from US FDA's Breakthrough Devices Program. While test-maker Banyan Biomarkers originally flirted with the PMA pathway, FDA swayed it to the de novo process, which the firm ultimately leveraged to gain the market go-ahead.
Approvals In Vitro Diagnostics

QUOTED. Feb. 15, 2018. Michael Minogue.

Check out what Abiomed CEO Michael Minogue said about his firm's launching of the Women's Initiative for Heart Recovery, which will create a new physician and patient advisory board to make heart recovery the standard of care for women suffering from cardiogenic shock.

Quoted Approvals

FDA Lowers Barrier To Market Penetration For Abiomed's Impella With Expanded Indication

FDA has removed "depressed ejection fraction" from the approved indication for Abiomed's Impella 2.5 and Impella CP based on results from the cVAD registry. The registry data support expanding the FDA-approved indication for the heart pumps during elective and urgent high-risk percutaneous coronary interventions, as well as for patients with cardiomyopathy leading to cardiogenic shock.
Approvals Clinical Trials

Stroke Decision-Support Software Gets US Approval

While US FDA works on a new guidance for clinical decision support software, the agency has OK'd the de novo application for Viz.AI Contact, a software tool to help detect early signs of strokes.
Approvals Digital Health

Novel Medical-Imaging Isotope Platform Nabs US FDA Approval

The RadioGenix System from NorthStar Medical Radioisotopes will be the first system to make the most common radioactive isotope used in imaging in the US in 30 years, using an innovative process that avoids the need for enriched uranium.

Medical Device BioPharmaceutical

US-First Reg Strategy Pays Off For Non-Drug Hemorrhoids Treatment

Singapore start-up Privi Medical has gained 510(k) clearance from the US FDA for its non-drug treatment for hemorrhoids. The clearance comes earlier than the company had expected and vindicates the firm's "US-first, CE mark later" strategy which was decided amidst tightening European regulations, according to Privi's CEO.

Approvals Innovation

ISC 2018: ARISE II Supports J&J's EmboTrap Stent-Retriever

The International Stroke Conference in Los Angeles featured new data that will support an FDA submission for J&J/Cerenovous' EmboTrap revascularization device. The findings showed a high rate of "first-pass" effectiveness and EmboTrap was successful in creating final substantial reperfusion in 90% of the treated patients.

Approvals Clinical Trials

Medrobotics' Flex Robot Gets US FDA All-Clear For New Indications

The Flex system, originally cleared in 2015 for transoral applications, is now available for robot-assisted visualization in general surgical, gynecological and thoracic procedures.

Gynecology & Urology Diagnostic Imaging

Device Week, Jan. 18, 2018 – Approvals And M&A: Looking At The Past and Into The Future

In this edition of Device Week, Medtech Insight’s Reed Miller, David Filmore and Catherine Longworth look back at the past year and the key trends in US and international product approvals, as well as in M&A activity. They also give their perspectives on what to look forward to in 2018.

Approvals M & A
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