Topic: FDA Approved

Eyenovia (Nasdaq:EYEN) announced today that the FDA approved its Mydcombi treatment for use with the Optejet […]

The FDA announced today that it approved Narcan 4 milligram (mg) naloxone hydrochloride nasal spray […]

Expanding Innovations recently announced that it has received 510(k) clearance from the US Food and […]

Nevro Corporation announced today that it has now initiated the full US market launch of […]

Vesalio has announced the successful initial use of its NeVa VS device in the USA […]

HistoSonics announced today that it received FDA approval for an investigational device exemption (IDE) trial of […]

Augmedics has announced that it has now treated more than 3,000 patients with its augmented […]

The COVID-19 pandemic has put lung health firmly in our minds. For those with chronic […]

Rafa Laboratories announced today that it received FDA approval for its 10mg Midazolam autoinjector for […]

The FDA announced today that it approved Enhertu, an IV infusion for the treatment of […]

AcuFocus announced today that it received FDA approval for its IC-8 Apthera intraocular lens for the […]

Inspire Medical Systems recently announced that FDA has approved additional MRI scan conditions for use […]

VisAR, an augmented reality surgical navigation system from healthcare technology company Novarad, has received US […]

Valencia Technologies Corporation has announced in a press release that it has completed the “world’s […]

FX Solutions has received US Food and Drug Administration (FDA) 510k approval for its new FX V135 […]

Medtronic said it has won FDA approval for the Onyx Frontier drug-eluting stent (DES). The […]

Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent […]

Abbott (NYSE:ABT) announced today that its Xience Skypoint drug-eluting stent platform is now available globally. […]

Hologic received approval from the Food and Drug Administration for an assay to quantify the viral load of […]

CVRx (Nasdaq:CVRX) announced today that the FDA approved magnetic resonance (MR) conditional labeling for its Barostim […]

Johnson & Johnson Vision announced today that it was named a winner of Fast Company’s […]

Silk Road Medical recently announced that the US Food and Drug Administration (FDA) approved expanded […]

Biotronik announced today that the FDA approved its Renamic Neo programmer for implanted cardiac rhythm management […]

Boston Scientific (NYSE:BSX) today announced it received FDA approval for its Vercise Neural Navigator with StimView […]

Bendit Technologies has received US Food and Drug Administration (FDA) 510(k) clearance of its Bendit21 […]

GE Healthcare recently announced that it received FDA premarket approval for its End-tidal (Et) Control […]

Bausch Health’s (NYSE:BHC) Bausch + Lomb and Clearside Biomedical (NSDQ:CLSD) today launched their Xipere product […]

Medtronic has received US Food and Drug Administration (FDA) approval of its Intellis rechargeable neurostimulator […]

The FDA today announced the authorization of the first laser-based device for removing IVC filters, […]

OrganOx announced today that it received FDA premarket approval (PMA) for its metra normothermic machine perfusion […]

The SoftVue system is intended to be used in addition to digital mammograms to screen for cancer among patients with dense breast tissue.

Haemonetics today said that it has received FDA approval for same-day discharge after atrial fibrillation […]

Abbott (NYSE:ABT) today announced U.S. FDA approval of its Portico with FlexNav TAVR system. The […]

TransMedics (NSDQ:TMDX) announced today that it received FDA premarket approval for its OCS Heart system. Andover, […]

The FDA improved an Impel NeuroPharma migraine treatment, a nasal spray intended to bring pain relief more quickly than drugs administered in other ways. It marks the first approval for the Seattle company, which has developed a proprietary nasal delivery technology.

MicroTransponder has announced US Food and Drug Administration (FDA) premarket approval of the Vivistim paired […]

The FDA approved its first nerve stimulation device designed to help people suffering from the […]

The latest generation of Medtronic’s self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut FX, is designed to enhance ease-of-use and predictable valve deployment.

The regulatory decision clears the way for more vaccine mandates in the U.S.