Topic: FDA Approved

PhotoniCare received FDA 510(k) clearance for its hand-held, noninvasive imaging scope that allows physicians to […]

Ear infections are notoriously common in children, but the usual treatment is relatively straightforward. An […]

Faced with growing competition in the market for diabetes devices, Tandem Diabetes Care’s stock shot […]

  The FDA today gave De Novo authorization for a Tandem Diabetes Care (NSDQ:TNDM) glycemic controller […]

AptarGroup today said it won FDA approval for its Unidose Liquid System that treats acute […]

End-stage renal disease (ESRD) patients experiencing kidney failure typically require hemodialysis in order to artificially […]

Johnson & Johnson (NYSE:JNJ) Vision announced that, after winning FDA approval, it launched the Tecnis Toric […]

Hologic has won FDA approval to introduce its 3DQuorum imaging technology to the U.S. market. […]

Dive Brief: FDA said Monday it approved a breakthrough-designated device used to deliver a treatment […]

Dive Brief: Medtronic has won FDA approval for its IN.PACT AV drug-coated balloon (DCB) in […]

Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for manufacturers and physicians this year, […]

Children with nearsightedness (myopia) may now benefit from the first contact lens approved by FDA […]

For 22 years, the world’s largest pure-play medical device company was the only player in […]

Hologic today said it received FDA approval for its 3DQuorum Imaging Technology that is powered […]

Nevro, a firm based in Silicon Valley, won FDA approval for its Senza Omnia spinal […]

Nevro (NYSE:NVRO) said today that it won FDA approval for and launched its Senza Omnia spinal […]

Nevro today announced it has received approval from the US Food and Drug Administration (FDA) […]

Flowonix Medical has won FDA approval for its Prometra II 40 ml programmable pump and […]

Royal Philips (NYSE:PHG) said today that two of the company’s new Stellarex drug-coated balloons received FDA […]

Will allow initiation of Early Feasibility Study in Head and Neck Cancer SAN DIEGO, Oct. 7, […]

Neocis said yesterday that it received FDA 510(k) clearance for a new robot-assisted drill to be […]

Medtronic (NYSE:MDT) said today that it won FDA approval for a clinical trial of its Infuse […]

Abbott (NYSE:ABT) announced today that the FDA has approved its low-dose, recharge-free spinal cord stimulation system with […]

Abiomed (NSDQ:ABMD) said today that it won pre-market approval from the FDA for the latest version […]

Avita Medical (ASX:AVH) said yesterday that the FDA approved an investigational device exemption for a pivotal […]

On 16 August, the US Food and Drug Administration (FDA) approved Edwards Lifesciences’ Sapien 3 […]

Former FierceMedTech Fierce 15 winner Axonics Modulation Technologies has received FDA approval for its rechargeable […]