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Delayed Twice, FDA Now Says It Won’t Release Its Harmonized QSR/ISO 13485 Draft Rule Until April 2020

First it was April 2019, then September 2019 – but both of those deadlines were missed. Now, the US agency has set a target date of April 2020 to release a draft regulation that will harmonize its Quality System Regulation (QSR) with international standard ISO 13485.

Regulation Standards Quality

AHA 2019: Conservative Approach Works As Well As Intervention For Stable Coronary Disease In ISCHEMIA Trial

The long-awaited results of the ISCHEMIA trial showed that patients with asymptomatic stable coronary disease get no apparent benefit from coronary intervention compared to a more conservative strategy with optimal medical management.

CMS Hospital Price Transparency Rule To Begin Public Reveal Of Device-Related Procedure Prices, Test Costs In 2021

The US Medicare agency on 15 November released a final cost transparency rule calling on hospitals to detail their standard “shoppable services” charges for X-rays, advanced imaging, laboratory tests and an array of other device-related procedures, beginning on 1 January 2021. Meanwhile, an accompanying proposed rule released by the CMS on the same day would require insurance health plans to provide to participants and beneficiaries the insurers’ negotiated rates for all covered health-care items and services.

Medicare Pricing Strategies Reimbursement

BSI’s Gary Slack Explains Why MDR Take-Up Is So Slow

There is not much demand currently for testing against the EU's Medical Devices Regulation (MDR). But demand for certificate renewal under the current medical device directives is very high. What does all this mean as the EU attempts to introduce tighter requirements for medical devices?

Europe EU Medical Device

Spotlight On Exec Chats

Exec Chat: XMed2019: How IBM Watson Health's CTO Uses Blockchain To Eliminate 'Friction Points' In Health Care

Ted Tanner, the new chief technology officer and chief architect of IBM Watson Health, recently sat down with Medtech Insight to discuss his plans for the company. In 2020, IBM will start testing the first use cases of its blockchain-based data information exchange network, a partnership with several health-care organizations, aimed at reducing administrative errors and costs. Tanner refers to blockchain as an "enablement platform" that augments computing power.

Exec Chat Artificial Intelligence

Execs On The Move: J&J And C-RAD Land Talent From Bayer And GE Healthcare; Abbott Eyes A Leadership Change In 2020

J&J chooses a former Bayer exec as chief information officer; C-RAD brings aboard as COO a GE Healthcare software director; Abbott Laboratories announces its longtime CEO will step down in 2020; and more.

Appointments Companies Medical Device

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Medtech IT: How To Stay Ahead As Technology Accelerates

Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found. Read this whitepaper to view more survey results and discusses how tech is changing Medtech.

Read the Whitepaper

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Close-Out Meetings With FDA Investigators: What Manufacturers Need To Know Before Their Next Inspection

When the US agency comes to inspect a manufacturer’s facility, one of the more important activities that occur is a close-out meeting. Consultant and former FDA investigations branch director Ricki Chase explains why these meetings, held daily or at the end of an audit – or both – can help make or break an inspection.

Compliance FDA Enforcement

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

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

Warning Letter Roundup & Recap – 19 November 2019

A manufacturer of in vitro diagnostic reagents was cited for premarket violations in the only device-related warning letter released by the US FDA this week.

Device Warning Letters FDA

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

FDA Advisory Panel Debates Science On Human Adverse Biological Reactions To Metal-Containing Devices

US FDA scientists and immunological experts discussed the latest science regarding patients’ biological reactions to metal implants and mercury in dental amalgam at a 13-14 November agency advisory committee meeting. The get-together was held to determine what additional actions the FDA can take to make sure certain patients are protected from immunological risks of the implants. The panel ultimately backed a transition away from mercury amalgam dental fillings and pushed for more research into risks associated with metal implants.

Safety FDA

Process Validation Can Be Problematic For Device-Makers. Here’s Why – And What Companies Can Do About It

Medical device manufacturers often stumble when conducting process validation activities. In this Q&A, former US FDA investigations branch director Ricki Chase explains what those hurdles are and offers tips to firms to make sure they’re on the road to compliance.

Quality Compliance

A Softer, Gentler FDA Inspectorate? It’s Possible With QSR/ISO 13485 Harmonization, Auditing Expert Says

Let’s be blunt: Device-makers aren’t particularly fond of facility inspections by the US FDA. From audits that can sometimes drag on for weeks to nightmarish inspections well-documented by industry experts, there’s no shortage of tales of investigators that were difficult to handle. But the agency’s ongoing rewrite of its Quality System Regulation to harmonize it with international standard ISO 13485 could “soften FDA’s inspectorate,” NSF International’s Brian Ludovico says. Also: How might the FDA’s Quality System Inspection Technique (QSIT) change, post-harmonization?

FDA Enforcement

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Warning Letter Roundup & Recap – 19 November 2019

A manufacturer of in vitro diagnostic reagents was cited for premarket violations in the only device-related warning letter released by the US FDA this week.

Device Warning Letters FDA

Process Validation Can Be Problematic For Device-Makers. Here’s Why – And What Companies Can Do About It

Medical device manufacturers often stumble when conducting process validation activities. In this Q&A, former US FDA investigations branch director Ricki Chase explains what those hurdles are and offers tips to firms to make sure they’re on the road to compliance.

Quality Compliance

A Softer, Gentler FDA Inspectorate? It’s Possible With QSR/ISO 13485 Harmonization, Auditing Expert Says

Let’s be blunt: Device-makers aren’t particularly fond of facility inspections by the US FDA. From audits that can sometimes drag on for weeks to nightmarish inspections well-documented by industry experts, there’s no shortage of tales of investigators that were difficult to handle. But the agency’s ongoing rewrite of its Quality System Regulation to harmonize it with international standard ISO 13485 could “soften FDA’s inspectorate,” NSF International’s Brian Ludovico says. Also: How might the FDA’s Quality System Inspection Technique (QSIT) change, post-harmonization?

FDA Enforcement

Commercial Explore this Topic

Set Alert for Commercial

Terumo Buys Vascular Therapy Biz Aortica

Terumo is acquiring the vascular therapy company to boost its AAA graft business.

M & A Deals Commercial

Recipharm Boosts Inhalation And Injectables Manufacturing By Acquiring UK’s Consort Medical

Sweden's Recipharm has agreed to buy UK-based Consort Medical for £505m ($652m) to become a leading inhalation-device company and top five global CDMO. 

Deals Manufacturing

Roundup: XMed2019: 7 Innovators To Watch

Medtech Insight features its shortlist of top innovators who showcased their products at the recent Exponential Medicine conference in San Diego.

Artificial Intelligence Digital Health

Nypro Experts: Adaptability And Agility Are More Critical Than Ever In Medtech

Nypro, a Jabil Company, offers design, engineering, supply chain and manufacturing services for the medical device, diagnostics, pharmaceutical and consumer health markets. In a contributed analysis, Jabil/Nypro's Joe McBeth, Erich Stein, Brad Womble and Doug Bond suggest the medical device industry has been relatively slow to adopt connected technologies, and must be ready to adapt more quickly in the future.

Analysis Business Strategies

Device Week, 14 November 2019 – Medtech Leaders Look To The Future At XMed 2019; Abbott Names New CEO

In this week's podcast, Medtech Insight managing editor Marion Webb summarizes her recent interviews with Ted Tanner, CTO of IBM Watson Health, and Catherine Mohr, president of the Intuitive Foundation, during the Exponential Medicine conference in San Diego. And deputy editor Reed Miller discusses the appointment of Robert Ford as the new CEO of Abbott Laboratories, the latest in a recent series of high-profile CEO appointments in medtech.

Device Week Artificial Intelligence

QUOTED. 14 November 2019. William Osborn.

Abbott's CEO Miles White will step down at the end of March 2020 after 21 years on the job. Robert Ford, Abbott's president and COO, will succeed White as Abbott's CEO. See what William Osborn, chair of Abbott's board of directors' nominations and governance committee, said about it here.

Quoted Appointments

Medtech Veteran Robert Ford Will Take Over As Abbott CEO From Miles White

Abbott’s current COO Robert Ford will become the company’s new CEO on 31 March, 2020. Miles White is stepping down after 21 years leading the diversified health-care products company.

Appointments Commercial

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

AHA 2019: Cardiawave Sees Positive Early Results For Non-Invasive Valve Disease Treatment

The French start-up claims first-in-man success for heart valve “softening” treatment and plans further trials for an EU launch.

Clinical Trials Innovation Research & Development

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

QUOTED. 19 November 2019. Benjamin Bertrand.

Cardiawave's non-invasive ultrasound therapy is feasible and safe in patients with severe symptomatic aortic stenosis, according to early trial results presented at the annual American Heart Association meeting. See what Cardiawave's CEO, Benjamin Bertrand, said about it here.

Quoted Research & Development

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

FDA Expands Indication For Axonics’ Incontinence System; Medtronic Claims Patent Infringement

The US FDA approved Axonics’ r-SNM sacral neuromodulation system for treating overactive bladder and urinary retention on 14 November. The agency approved the same device for treating chronic fecal incontinence on 9 September. Axonics expects r-SNM to rival Medtronic's InterStim II non-rechargeable sacral neuromodulation system, but Medtronic claims the r-SNM technology infringes on Medtronic’s intellectual property.

Approvals Legal Issues

QUOTED. 15 November 2019. Krishna Rocha-Singh.

Ongoing scrutiny has not explained an apparent link between paclitaxel-coated cardiac devices and an increased mortality rate, speakers said at the Vascular Interventional Advances (VIVA) 2019 conference in Las Vegas. See what Krishna Rocha-Singh, a VIVA board member, said about it here.

Quoted Research & Development
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