[Editors' note: For sortable and searchable tables of all US and non-US approvals and clearances in 2017 and previous years, check out our Approvals Tracker.]
US Approvals Analysis: Abbott Leads Another Strong Month For Novel Approvals
Abbott Laboratories accounted for two of five original PMA approvals recorded by US FDA in August. That update and more from Medtech Insight's Approvals Tracker.
More from Approvals
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A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.
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The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.
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The US FDA's clearance of QP-Prostate CAD positions the company to support US health care providers and growing markets for fusion biopsy and focal therapy, said Quibim CEO and founder Angel Alberich-Bayarri.
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Tempering expectations on the immediate market impact for the upgraded continuous glucose monitor, Dexcom notes insurance coverage and pump integrations will take time to finalize.
More from Policy & Regulation
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A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.
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Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.
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The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.