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QUOTED.

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QUOTED. Jan. 18, 2017. Jeff Shuren.

Check out what FDA device director Jeff Shuren had to say about his center's path to simplicity, one part of CDRH's three-year strategic priorities.
Quoted Regulation

QUOTED. Jan. 17, 2018. Ariel Weinstein.

Check out what OCON Medical CEO Ariel Weinstein had to say about his company's efforts to leverage its "intrauterine ball" hormone-free contraceptive platform for future pipeline projects.
Quoted Commercial

QUOTED. Jan. 16, 2018. Kelly Londy.

Check out what Lumicell CEO Kelly Londy had to say about why the device-maker is developing its LUM system to treat prostate, colorectal, esophageal and pancreatic cancers.
Quoted Clinical Trials

QUOTED. Jan. 15, 2018. Oliver Bisazza.

Check out what MedTech Europe's Oliver Bisazza had to say about how long it will take for notified bodies to become approved under the EU's Medical Device and IVD Regulations.
Quoted Europe

QUOTED. Jan. 12, 2018. Raymond Cohen.

Check out who Axonics Modulation Technologies CEO Raymond Cohen says would make up his dream team to take the company’s technology from bench to market.
Quoted Business Strategies

QUOTED. Jan. 11, 2018. Patrick Hope.

Check out what Patrick Hope, executive director of the Medical Imaging & Technology Alliance (MITA), had to say about why his organization created a new director-level post targeting cybersecurity.
Quoted Cybersecurity

QUOTED. Jan. 10, 2018. Ian Gilham.

Check out what Ian Gilham, an IVD industry veteran and former CEO of Axis-Shield, had to say about how medical device firms can pick themselves back up after product or manufacturing problems strike.
Quoted Business Strategies

QUOTED. Jan. 9, 2018. Mark Durivage.

Check out what QA/RA expert Mark Durivage had to say about device-makers that are "afraid" to perform process validation activities.
Quoted Compliance

QUOTED. Jan. 8, 2018. Susan Stimson.

Check out what Intersect ENT's Susan Stimson had to say about efforts the manufacturer is making to evolve from a medical device company to a combination products company.
Quoted Ear, Nose & Throat

QUOTED. Jan. 5, 2018. Jon H. Hoem.

Check out what CorFlow CEO Jon H. Hoem had to say about device-makers that try to save money by hiring staff who aren't necessarily the most qualified.
Quoted Business Strategies

QUOTED. Jan. 4, 2018. Justin Barad.

Check out what Osso VR CEO – and pediatric orthopedic surgeon – Justin Barad had to say about how patient preference could boost interest in minimally invasive knee and hip arthroplasties.
Quoted Orthopedics

QUOTED. Jan. 3, 2018. Orrin Hatch.

Check out what Republican Orrin Hatch a staunch medtech supporter  had to say about his impending retirement from the US Senate.
Quoted Leadership

QUOTED. Jan. 2, 2018. Vito Pirrera & John Jordon.

Check out what Vantage Consulting Group's Vito Pirrera and John Jordon had to say about companies using machine vision for inspecting high-throughput medical device parts.
Quoted Manufacturing

QUOTED. Dec. 29, 2017. Thomas Burns.

Check out what Glaukos Corp. president and CEO Thomas Burns has to say about his firm's minimally invasive glaucoma surgery (MIGS) iStent inject device used for treating glaucoma. Glaukos has submitted a pre-market approval application to US FDA for the product.
Quoted Commercial

QUOTED. Dec. 28, 2017. Jeff Shuren.

Check out what Jeff Shuren, director of US FDA's device center, has to say about a new proposed program from the agency that looks to streamline the Medical Device Reporting (MDR) process through the use of summary adverse event reports.
Quoted Safety
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