Topic: regulatory approvals
Fierce 15 winner MaxQ AI received an FDA clearance for its artificial intelligence software that rapidly detects brain bleeds in CT scans.
The FDA approved Ortho’s Vitros fourth-generation HIV combination test, which detects HIV-1 and HIV-2 antibodies and the p24 antigen.
Medtronic received FDA approval for its Valiant Navion thoracic stent graft for minimally invasive repair of lesions of the descending thoracic aorta.
The FDA approved a molecular diagnostic test that can match blood donors using patient DNA.
The FDA broadened its premarket approval of Carl Zeiss Meditec’s laser eye treatment to include nearsighted patients with astigmatism.
The FDA cleared a direct-to-consumer hearing aid developed by Bose, opening the door for other consumer electronics companies.
Illumina received its first official approval in China for its MiSeqDx benchtop sequencer, allowing it to directly market NGS testing in the country.
The FDA approved Endomag’s nonradioactive, magnetic, liquid tracer for mapping lymph nodes in breast cancer patients undergoing mastectomy.
Medtronic and United Therapeutics received approval for a fully implantable infusion pump filled with Remodulin for pulmonary arterial hypertension.
Gottlieb thinks revisions are needed to give the FDA authorities that are a better fit for modern diagnostics than the current 510(k) pathway.