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NZ To Replace 'Outdated And Piecemeal' Device Rules

There are significant changes in store for New Zealand’s medical device sector, including a new regulator and a set of pre- and post-market regulatory controls.

New Zealand Policy & Regulation Clinical Trials

About Three Months' Worth Of Carryover Device Fees Remaining, FDA's Gottlieb Says

US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.

FDA Regulation United States

Pre-Cert Program Will Start Off Slow With De Novo Framing, But Big Questions Remain

Several experts suggest FDA is toeing the line in keeping the first stage of its pre-certification program for software-as-a-medical-device products legally permissible, but it may be limited in scope for the time being. Meanwhile, one attorney says the agency is sending mixed messages about whether the current program will sit comfortably within FDA's current authorities.

Digital Health Regulation Medical Device

2018 Global Approvals Analysis: Emerging-Market Regulators And Companies Make Their Presence Felt

The list of medical device approvals outside the US captured by Medtech Insight's Approvals Tracker in 2018 was shorter than in 2017, but it includes approvals from 14 different territories – more than one-fifth of the approvals came from emerging markets – covering more than 50 different indication categories.

Approvals Emerging Markets Research & Development

QUOTED. Jan. 15, 2019. Namal Nawana.

The new CEO of Smith & Nephew, Namal Nawana, sat down with Medtech Insight during the JP Morgan Healthcare Conference to discuss his plans for putting the British medical giant on track for growth. See what he had to say here about the company's M&A strategy.

Commercial Exec Chat M & A

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Optimizing Product Lifecycle Management With Real-World Evidence

An increasingly data-rich healthcare sector presents both opportunities and challenges for the MedTech industry, just as it does for the health systems and patients served by MedTech products. Used intelligently and appropriately, the vast quantities of real-world data emanating from multiple healthcare sources provide the raw material for real-world evidence (RWE) that can inform strategy and decision-making throughout the MedTech-product lifecycle.

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Policy & Regulation Explore this Topic

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Device Week, Jan. 11, 2019 – A New Plan From NHS In A Period Of UK Uncertainty

On this week's podcast, Ashley Yeo talks about the "Long Term Plan" published by the UK's National Health Service this week, and the implications of Brexit.

Device Week United Kingdom Market Access

Benefit-Risk Is Front-And-Center In Latest Revision Of International Risk Management Standard ISO 14971

The International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest redo of ISO 14971, the voluntary standard that instructs device-makers on how to best put together a risk management program. Regulators – including US FDA – are increasingly considering benefit-risk when weighing product availability and regulatory compliance issues. And Jos Van Vroonhoven, convener of a joint working group that revised the standard, says a more global regulatory emphasis on risk management and a desire to clarify the document in general led ISO to revise the standard. Also: Van Vroonhoven identifies four updated clauses in the revamped standard that firms should keep a sharp eye on.

Risk Management Standards International

QUOTED. Jan. 16, 2019. Bradley Thompson.

US FDA is taking a cautious approach to rolling out the test phase of its pre-certification program for digital health products to keep it within legal limits. See what Bradley Merrill Thompson, an attorney at Epstein Becker & Green, had to say about the limited scope of the current plan here.

Quoted Digital Health

Warning Letter Roundup & Recap – Jan. 15, 2019

No device-related warning letters were released by US FDA the week of Jan. 15.

Device Warning Letters FDA

New Finance Chair Grassley Will Push Device Tax Repeal, Try To Lower Health-Care Costs

In setting his agenda for the US Senate Finance Committee in 2019, incoming Chairman Chuck Grassley, R-Iowa, says he will continue to cosponsor bills to end the device tax, focus on lowering prescription drugs and other medical product health-care costs, expand tax breaks for business, and make sure Congress has a strong hand in negotiating trade and tariff talks.

Legislation Regulation

Lawsuit Seeks Expanded Medicare Reimbursement For CGM

A law firm has filed a class action suit against the US Department of Health and Human Services trying to force broader Medicare reimbursement of continuous glucose monitors. Currently, federal health programs will only cover specific types and uses of the diabetes treatment technology.

Legal Issues Reimbursement

Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations

Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.

Europe Medical Device

Manufacturers Support Health Canada Device Safety Plan, But Clinics May Adjust More Slowly

Device companies in Canada and foreign firms selling to the market likely will be able to adjust to Health Canada’s stepped-up device safety “action plan,” but small health-care facilities and some clinics may face challenges in adjusting to new reporting rules, says the agency and Canadian device industry group MEDEC.

Safety Regulation

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

The Path Forward: Retooled Technical Doc TR 24971 Guides Device Firms On Risk Management Standard ISO 14971

When ISO TR 24971 – a Technical Report that offers device-makers guidance on international risk management standard ISO 14971 – was first published in 2013, not many people knew it existed. But now that the TR is being updated in tandem with ISO 14971, it's a must-have document that includes valuable instruction related to a host of risk-related issues. In particular, TR 24971:20XX includes informative new annexes that tackle device cybersecurity and how firms should handle risk management for products designed before ISO 14971 existed.

Risk Management Standards

Crosswalk: ISO 14971:2007 Vs. ISO 14971:20XX

Here's a table cross-referencing the current 2007 version of international risk management standard ISO 14971 and its revised draft version, which will likely be published by the International Organization for Standardization (ISO) later this year.

Risk Management Standards

'Implant Files': New Device-Failure Database Benefits Companies And Savvy Consumers, But May Befuddle Others, Experts Say

The International Medical Devices Database from the International Consortium of Investigative Journalists – an output of ICIJ's recent string of "Implant Files" stories that were critical of industry – offers information on more than 700,000 device recalls, field safety notices and safety alerts documented in 11 countries. While device-makers and shrewd consumers will discover a bevy of useful data in the public repository, it could prove confusing for laypeople. A recalls expert and an ex-FDA official weigh in.

Implant Files International

Commercial Explore this Topic

Set Alert for Commercial

20-Year Sentence Upheld For ArthroCare Exec

The Fifth Circuit Court of Appeals has rejected former ArthroCare CEO Michael Baker’s appeal of a 20-year sentence. Baker was convicted on charges related to a $750m fraud case.

Medical Device Commercial Legal Issues

Execs On The Move: Shockwave, Natera Updates

Prenatal testing firm Natera appoints a new chief operating officer and interventional cardiovascular device firm Shockwave Medical seats a new board chairman, among recent medtech and biotech personnel moves.

Appointments Commercial

Medtech Money Flow: M&A & VC Deals, Jan. 7-13, 2019

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Jan. 7-13, 2019.

M & A Financing

Exec Chat: New Smith & Nephew CEO Namal Nawana Outlines Growth Strategy At JP Morgan

About eight months into his role as CEO of Smith & Nephew, Namal Nawana has revamped the firm's leadership team and created strategic imperatives to put the British medical device giant on the growth track. Medtech Insight sat down with Nawana at this year's JP Morgan Healthcare Conference in San Francisco to learn more about his plans for growing Smith & Nephew.

Commercial Exec Chat

Execs On The Move: C-Suite Developments At Beltone, ImaginAb And Ra Medical

This week, a new president at otolaryngology device firm Beltone, plus a chief business officer comes on board at immune and oncology imaging company ImaginAb. And Ra Medical Systems, maker of laser-based therapy devices, welcomes a chief commercial officer.

Appointments Commercial

GE Healthcare Forges Five-Year Precision Medicine Partnership With Vanderbilt

GE Healthcare is making a bid to become the leader in precision medicine by collaborating with Vanderbilt University Medical Center to develop AI-powered diagnostic tools for cancer care.

Artificial Intelligence Personalized Medicine

Ascensia Inks Distribution Deal To Enter CGM Market

Ascensia Diabetes Care plans to start selling its first continuous glucose monitoring devices this year based on a distribution deal with Zhejiang POCTech Co. Ltd, announced Jan. 7 at the JP Morgan Healthcare Conference. The partnership will also include product development.

Deals Commercial

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

2018 US Device Approvals: The Year Of De Novos And Digital Health

It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.

Approvals FDA Digital Health

Results Recap: Pulse Biosciences Announces Results Of Sebaceous Hyperplasia Study

This week's edition of Medtech Insight's Results Recap, the weekly roundup of major device trial-results from Meddevicetracker.com, includes just one entry as the 2019 is off to a slow start for trial results announcements. Pulse Biosciences announced encouraging results from the clinical efficacy study of its Nano-Pulse Stimulation technology to treat patients with sebaceous hyperplasia.

Tracking Trials Research & Development

Bruin Lands De Novo On Pressure Ulcer Assessment Tool

US FDA has granted a de novo clearance to Bruin Biometrics’ SEM Scanner, which is the first device cleared to assess parts of a patient’s body that may be at risk for pressure ulcers.

Approvals Wound Management

Global Device Approvals, Weekly Snapshot: Endovascular Entries

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. Terumo and Cook each nabbed US FDA approvals for endovascular devices.

Approvals Research & Development

Starts & Stops: Abbott Stops Two-Clip Trial Of MitraClip; PROMISE Trial of Eversense XL CGM Begins

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 30 to Jan. 7, including announcements from Abbott, Roche, Insightec, and Terumo.

Starts & Stops Tracking Trials

Starts & Stops: Vectorious Launches First-In-Human Trial Of V-LAP Left-Atrial Monitor

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 24-30, so there is just one entry this week - Vectorious' announcement of the first-in-human trial of the V-LAP left-atrial monitor.

Starts & Stops Tracking Trials

Global Device Approvals, Weekly Snapshot: FoundationOne CDx In Japan

A snapshot of global medical device approvals captured during the past two weeks by Medtech Insight's Approvals Tracker. Among the noteworthy approvals in the closing days of 2018, Roche/Foundation Medicine captured Japanese approval for its comprehensive companion diagnostic.

Approvals Innovation
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