FDA Approved

FDA approves Philips’ low-dose Stellarex balloons

Released on October 16, 2019

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

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FDA Approved Oncology

Aethlon Medical Announces FDA Approval Of IDE For Oncology Indications

Released on October 7, 2019

Will allow initiation of Early Feasibility Study in Head and Neck Cancer SAN DIEGO, Oct. 7, 2019 /PRNewswire/ — Aethlon Medical, Inc. (Nasdaq: AEMD), […]

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FDA Approved Robotics

FDA clears new drill for Neocis Yomi robot-assisted dental surgery device

Released on October 1, 2019

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

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FDA Approved Orthopedic Spine

Medtronic announces Infuse spine trial

Released on September 27, 2019

Medtronic (NYSE:MDT) said today that it won FDA approval for a clinical trial of its Infuse bone graft in transforaminal lumbar interbody […]

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Digital Health FDA Approved Neuro

FDA approves Abbott’s recharge-free spinal cord stimulator

Released on September 26, 2019

Abbott (NYSE:ABT) announced today that the FDA has approved its low-dose, recharge-free spinal cord stimulation system with up to 10-year battery life for […]

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Cardiology FDA Approved

Abiomed wins FDA approval for latest Impella heart pump

Released on September 25, 2019

Abiomed (NSDQ:ABMD) said today that it won pre-market approval from the FDA for the latest version of its Impella heart pump. The […]

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Biotech FDA Approved

FDA OKS Avita Medical trial for Recell in soft tissue reconstruction

Released on September 18, 2019

Avita Medical (ASX:AVH) said yesterday that the FDA approved an investigational device exemption for a pivotal trial of its Recell autologous cell […]

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FDA Approved Structural Heart

FDA approves Sapien 3 Ultra, Sapien 3, and CoreValve for low-risk TAVI

Released on September 17, 2019

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

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FDA Approved Neuro

Axonics nets FDA approval for its rechargeable sacral neuromodulation implant

Released on September 10, 2019

Former FierceMedTech Fierce 15 winner Axonics Modulation Technologies has received FDA approval for its rechargeable neuromodulation implant to treat bowel dysfunction. […]

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FDA Approved Spine Surgery

WONTECH’s Holmium laser ‘Holinwon Prima’ Received FDA approval

Released on September 6, 2019

SEOUL, South Korea, Sept. 6, 2019 /PRNewswire/ — WONTECH, a leading Korean medical device company, announced that its Holmium laser device, Holinwon Prima, […]

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FDA Approved Ophthalmology

FDA approves Alcon’s AcrySof IQ PanOptix trifocal IOL

Released on August 27, 2019

Alcon (NYSE:ALC) said today that it won FDA approval for its AcrySof IQ PanOptix trifocal intraocular lens and is preparing…

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FDA Approved Neuro

Barostim Neo Neuromodulation Device for Heart Failure Wins FDA Approval

Released on August 27, 2019

CVRx, a Minneapolis, Minnesota company, won FDA approval for the first neuromodulation device designed to address heart failure…

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