FDA Approved

J&J Vision launches Tecnis Toric II intraocular lens in U.S.

Released on December 5, 2019

Johnson & Johnson (NYSE:JNJ) Vision announced that, after winning FDA approval, it launched the Tecnis Toric II one-piece intraocular lens (IOL) to […]

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FDA Approved Radiology Women's Health

3DQuorum Mammography Tech Reduces Number of Images for Radiologists to Review

Released on December 3, 2019

Hologic has won FDA approval to introduce its 3DQuorum imaging technology to the U.S. market. Powered by the company’s Genius AI […]

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Drug-delivery FDA Approved

FDA approves J&J spinout’s device for kids with recurring ear infections

Released on November 26, 2019

Dive Brief: FDA said Monday it approved a breakthrough-designated device used to deliver a treatment for recurrent ear infections in both […]

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Drug-delivery FDA Approved

FDA approves Medtronic’s AV drug-coated balloon for ESRD patients

Released on November 22, 2019

Dive Brief: Medtronic has won FDA approval for its IN.PACT AV drug-coated balloon (DCB) in end-stage renal disease (ESRD) patients, the […]

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Drug-delivery FDA Approved Vascular

Medtronic FDA Approval Marks a Turnaround in the Paclitaxel Story

Released on November 21, 2019

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

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FDA Approved Ophthalmology

FDA Approves First Contact Lens to Slow the Progression of Nearsightedness in Kids

Released on November 18, 2019

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

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FDA Approved Neuro

Axonics Isn’t Letting Medtronic Stand in Its Way

Released on November 17, 2019

For 22 years, the world’s largest pure-play medical device company was the only player in sacral neuromodulation, a space that addresses […]

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AI FDA Approved Imaging

Hologic wins FDA approval for 3DQuorum AI imaging technology

Released on November 12, 2019

Hologic today said it received FDA approval for its 3DQuorum Imaging Technology that is powered by the company’s Genius AI. The […]

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FDA Approved Neuro Orthopedic

Senza Omnia Stimulator for Chronic Pain, with Widest Frequency Range, FDA Approved

Released on November 12, 2019

Nevro, a firm based in Silicon Valley, won FDA approval for its Senza Omnia spinal cord neurostimulation system for chronic pain […]

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FDA Approved Neuro

Nervo launches Senza Omnia spinal cord stimulation system

Released on November 6, 2019

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

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FDA Approved Neuro

Nevro announce launch of a new medical device for the treatment of chronic pain

Released on November 4, 2019

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

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Drug-delivery FDA Approved

FDA approves Flowonix’s Prometra II programmable pump

Released on October 25, 2019

Flowonix Medical has won FDA approval for its Prometra II 40 ml programmable pump and its associated software for intrathecal infusion. […]

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