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QUOTED.

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QUOTED. 23 August 2019. Rod Cotton.

Roche Diagnostics Corp. is moving closer to realizing its vision of personalized health care through partnerships and applying machine learning and data sourcing. See what Rod Cotton, Roche Diagnostics' senior VP of commercial operations, said about it here.

Quoted Personalized Medicine

QUOTED. 22 August 2019. Omar Ishrak.

While Medtronic PLC's Brain Therapies business was by far the fastest-growing unit in the first quarter of fiscal 2020, sales of spine surgery products grew faster in the first quarter than they have in nine quarters. See what Medtronic's CEO Omar Ishrak said about it here.

Quoted Sales & Earnings

QUOTED. 21 August 2019. David Smith.

The largest diagnostics companies, including Roche Diagnostics Corp., showcased their latest products at the recent American Association for Clinical Chemistry's (AACC) conference in Anaheim. See what David Smith, regional business manager for Roche's Navify decision-support portfolio, said about it here.

Quoted Market Intelligence

QUOTED. 20 August 2019. Suzanne Winter.

Medtronic and the nonprofit health plan Capital District Physicians' Health Plan Inc. (CDPHP) announced they'll be collaborating on an outcomes-based agreement for diabetes patients using Medtronic's insulin pumps. See what Suzanne Winter, VP of Medtronic's Diabetes Group said about it here.

Quoted Healthcare Systems

QUOTED. 19 August 2019. Michael Carrel.

AtriCure Inc. has closed a $300m structured deal to acquire SentreHEART Inc., the privately held developer of the Lariat percutaneous left atrial appendage (LAA) closure device. See what AtriCure CEO Michael Carrel said about it here.

Quoted Deals

QUOTED. 16 August 2019. Melissa Michurski.

Over the past few years, the US FDA has been pulling enforcement punches, relying more on holding face-to-face regulatory meetings than firing off warning letters. See what FDA Compliance Branch director Melissa Michurski said about the meetings here.

Quoted FDA

QUOTED. 15 August 2019. Amy Abernethy.

Here's what Amy Abernethy, the second-highest ranking official at the US FDA, thinks about the use of wearable devices to collect accurate patient data for clinical trials and remote monitoring.

Quoted Digital Health

QUOTED. 14 August 2019. Bradley Merrill Thompson.

Long-delayed changes to the US FDA's approach to postmarketing safety reporting for combination products are set to come into effect in 2020, following the agency’s recent release of a final guidance document on the issue. See what Combination Products Coalition general counsel Bradley Merrill Thompson said about the guidance here.

Quoted Post Market Regulation & Studies

QUOTED. 13 August 2019. Judge Andre Birotte Jr.

Product liability lawsuits involving breast implants made by Johnson & Johnson's unit Mentor Worldwide have been dismissed by a California federal judge. See what Judge Andre Birotte Jr. said about it here.

Quoted Legal Issues

QUOTED. 12 August 2019. Deepak Nath.

At this year's AACC conference, Medtech Insight caught up with Siemens Healthineers' president of laboratory diagnostics Deepak Nath. See what Healthineers' Nath said about plans for their flagship Atellica solution here.

Quoted Exec Chat

QUOTED. 9 August 2019. Julie Khani.

A lawsuit attempting to change how lab test fees can be determined under Medicare recently got the go-ahead from the US Court of Appeals. The suit was filed by trade group the American Clinical Laboratory Association. See what ACLA president Julie Khani said about it here.

Quoted Medicare

QUOTED. 8 August 2019. Phil Pontikos.

US FDA investigator and national device expert Phil Pontikos says he's concerned about the large number of medical device recalls because of troubles with sterilization activities. Check out his comments here.

Quoted Compliance

QUOTED. 7 August 2019. Andrew Newland.

UK-based liquid biopsy company Angle PLC is expecting to make a landmark regulatory submission to the US Food and Drug Administration early in the fourth quarter of 2019 for Parsortix, which aims to detect and capture circulating tumor cells in cancer patients. See what Angle's CEO, Andrew Newland, said about it here.

Quoted Clinical Trials

QUOTED. 6 August 2019. Katherine Owen.

In the second quarter of 2019, Stryker reported a 6% growth in sales of orthopedic devices, led by the Mako robotic surgery platform. See what Katherine Owen, Stryker's VP of strategy and investor relations, said about it here.

Quoted Sales & Earnings

QUOTED. 5 August 2019. John Milad.

The latest salvo to improve kidney care in the US is a recent executive order from the Trump administration, with one of the key goals being to raise the percentage of dialysis patients on home dialysis to 80% by 2025 from 12% today. See what John Milad, CEO of UK-based Quanta Dialysis Technologies, said about it here.

Quoted Innovation
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