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Approvals

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FDA Clears Pentax’s Easier-To-Disinfect Duodenoscope

The US FDA cleared Pentax Medical’s new duodenoscope as the first in the US with a disposable elevator part that reduces the number of parts needed to be disinfected compared to earlier designs.

Approvals Regulation Research & Development

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Global Approvals Snapshot: November 2019

November’s approvals include the US FDA approval of Medtronic’s In.Pact AV paclitaxel-coated balloon, for the treatment of arteriovenous access in patients with end-stage renal disease, and a CE mark that expands the indication for Edwards’ Sapien 3 TAVR device to include patients at low-risk during surgery.

Approvals Clinical Trials

QUOTED. 28 November 2019. Jeff Shuren.

Tusker Medical won US FDA approval for its Tubes Under Local Anesthesia (Tula) System, the first device allowing ear tubes to treat recurrent ear infections in children to be installed in the physician's office under local anesthesia. See what Jeff Shuren, director of the agency's device center, said about it here.

Quoted Approvals

Ear-Tube Insertion Moves To Physician Offices With Breakthrough Device

A device newly approved by the US FDA will allow physicians to insert ear tubes to treat recurrent ear infections in the office, eliminating the risks of general anesthesia. The Tubes Under Local Anesthesia (Tula) System was reviewed via the agency’s breakthrough device pathway.

Approvals FDA

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.

Regulation Approvals

QUOTED. 22 November 2019. Daniel McBride.

The US FDA has approved CooperVision Inc.’s MiSight, the first contact lens that can help slow the progression of nearsightedness (myopia) in children. See what CooperVision president Daniel McBride said about it here.

Quoted Approvals

QUOTED. 20 November 2019. Jeff Shuren.

The US FDA has cleared the Pentax Medical Video ED34-i10T2, the first duodenoscope for the US market with a sterile, disposable elevator component designed to reduce the number of parts that need to be disinfected between uses. See what Jeff Shuren, director of the agency’s device center, said about it here.

Quoted Approvals

CooperVision Nabs Approval On Pediatric Contact Lens

A newly approved contact lens from CooperVision promises to slow the progression of nearsightedness when prescribed to children aged 8 to 12.

Approvals Ophthalmology

FDA Clears Pentax’s Easier-To-Disinfect Duodenoscope

The US FDA cleared Pentax Medical’s new duodenoscope as the first in the US with a disposable elevator part that reduces the number of parts needed to be disinfected compared to earlier designs.

Approvals Regulation

QUOTED. 18 November 2019. Raymond Cohen.

Medtech giant Medtronic filed a patent infringement suit against Axonics, alleging Axonics' sacral neuromodulation technology infringes four of Medtronic's patents for implantable electrical stimulation lead fixation methods and transcutaneous inductive charging for implantable medical devices. See what Axonics CEO, Raymond Cohen, said about it here.

Quoted Approvals
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