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A No-Predicate 510(k) Future? Pending US FDA Policy Might Forge A Path

510(k) clearances are the US market on-ramp for most devices, and proving the device is similar enough to an already-marketed product is the entry toll. But a policy in development at FDA's device center offers an optional approach that avoids predicate comparisons. Center director Jeffrey Shuren says in an interview that he expects the new approach will become the "pathway of choice" for many companies, potentially upending what has been a defining characteristic of the device regulatory landscape for decades.

Regulation FDA United States

MDR And IVDR Fail Risk-Benefit Assessment, EU Reg Expert Says

"I fail to see any merit in this piece of dismally bad legislation. It is absolutely in no one’s interest," says consultant and regulatory expert Jaap Laufer, who predicts disastrous impact on many companies and the end of notified bodies as we know them.

Europe Regulation Medical Device

Siemens Adds Infectious Disease Tests With Luxembourg's Fast-Track Diagnostics

Siemens Healthineers has signed an agreement to acquire Luxembourg-based Fast Track Diagnostics (FTD) the developer of diagnostics that can distinguish between viral, bacterial, or other infections in one test. The deal comes as Siemens is shaping up to float Healthineers, as an independently publicly-listed company.

M & A Deals In Vitro Diagnostics

QUOTED. Dec 15, 2017. Jaap Laufer.

Emergo's Jaap Laufer says the oncoming Medical Device and IVD Regulations have serious flaws that could lead to the demise of the EU notified body system. Check out what he says might result.
Europe Regulation Medical Device

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Policy & Regulation Explore this Topic

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Retroactive Device-Tax Suspension Won't Work, Industry Says, Pressing For Urgent Action

AdvaMed told Republican leaders of the House and Senate that they should rethink any plans to wait until next year to pass a retroactive suspension of the device tax, after the tax has already been reinstituted. The tax needs to be addressed by Dec. 31 to avoid a costly, bureaucratic nightmare, the industry group argues.

Policy Legislation United States

European Commission Sorts Medtech Working Groups And Creates New One

The current European Commission medtech working group structure has evolved over the last 25 years. Now some changes are needed.

Europe Medical Device Regulation

Power Morcellator Use Increases Cancer Risk, FDA Verifies

There is a 1-in-225 to 1-in-580 risk that women getting fibroid removal surgery through hysterectomies or myomectomies may have hidden uterine sarcomas, US FDA said Dec. 14, and verified that power morcellation use during the surgeries will result in higher rates of cancer recurrence.

Gynecology & Urology Regulation

US GAO: Veterans Affairs Falls Short In Med-Supply Purchase Revamp

An attempt by the US Department of Veterans Affairs to institute a new system for ordering medical supplies has gotten off to a rough start, with staffing issues, problems in formulary design and non-competitive contracts all muting the impact, according to the Government Accountability Office.

Medical Device Policy

'Least Burdensome' Supersized? Draft Guidance Outlines An Expanded View Of The US FDA Concept

The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.

Regulation Medical Device

Quoted. Dec 14, 2017. JC Scott.

Check out what top AdvaMed lobbyist JC Scott has to say about the  effort to fit an extended five-year moratorium on the device excise tax into Congress' end-of-year rush.
Legislation Business Strategies

Protecting Against Individual Prosecutions: Execs Remain A Focus, But There Are Ways To Reduce Risks

As the US Justice Department continues its focus on individual liability in device industry enforcement, it’s more important than ever that manufacturers bring executives in early on problems to limit liability.

Regulation Legal Issues

FDA Authorizes Emergency Use Of Devices In War Time, Bill Signed By The President Clarifies

President Trump signed off on legislation allowing US FDA to authorize additional emergency uses for medical products to reduce deaths and impacts of injuries caused by "agents of war." The signature ends a turf battle between FDA and the Department of Defense over authorizing products needed quickly under the emergency conditions of war.

Policy Legislation

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Device Week, Dec. 6, 2017 – How Investigator Familiarity Breeds Recalls, Poor Quality

On this week’s podcast, we highlight an eye-opening study that shows that the chummier a device-maker is with US FDA investigators, the more likely it is that those firms will experience quality system troubles and face costly product recalls.

Device Week Quality Control

BFFs With FDA? Repeat Visits From Investigators Can Lead To Poor Device Quality, Recalls, Study Suggests

When a US FDA investigator is overly familiar with a company and its people, it can lead to a weaker facility inspection that might not uncover quality system problems – which in turn could lead to troublesome devices and recalls. So says a study conducted by professors at the University of Wisconsin, Indiana University and the University of Minnesota, which found that a device-maker's recall hazard increases 21% when it's inspected a second time by the same investigator. Even more concerning: The recall hazard shoots up 57% after an investigator's third audit of a firm. Might rotating investigator assignments help? And how might the agency's new "program alignment" inspectional scheme affect how often an investigator visits a particular firm?

Quality Control Recalls

5 Ongoing US FDA Device Center Pilot Programs: A Listing

Having trouble keeping track of the many pilot programs offered by US FDA's device center? Then this handy listing of ongoing pilots should help.

FDA Quality Control

Commercial Explore this Topic

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Device Week, Dec. 14, 2017 – MTI 100

On this week's podcast, we discuss our latest MTI 100 rankings, providing a view on top revenue-getters in the medtech space, and we look at issues that are driving up and down movements on the list.

Commercial Business Strategies Deals

Pain Is Biggest Market For Transdermal Drug Delivery But Not A Patch Over Neuro For Growth

The growing aging population and rising obesity rates are paving the way for patch-based drug delivery systems to treat such common age-related diseases as Alzheimer's and Parkinson's, hormonal deficiencies, heart disease, as well as for managing acute and chronic pain patients. According to a new report by Meddevicetracker, the global market for transdermal patch products will reach $8.1bn by 2021, a CAGR of 2.9% from 2016. In this feature, we'll take a closer look at the overall market and the key players in the individual segments in this overall market. We'll take a deep dive into the neurological disorders segment, which is expected to see the biggest growth in the overall segment. We'll also feature physician specialty surveys outlining the pros and cons of using patch-based systems.

Combination Products Market Intelligence

QUOTED. Dec 13, 2017. Kyparissia Sirinakis.

Check out what Kyparissia Sirinakis, managing partner of Epidarex Capital, had to say about misperceptions related to early-stage medtech venture investing.
M & A Medical Device

UK Device Manufacturers Must Contingency Plan For A Hard Brexit

The compromise tone adopted last week by the UK government on key "phase 1" issues of an EU-UK Brexit deal was welcomed by UK health-care products industries, but with uncertainty over phase 2 – the future EU trade deal – still hampering UK business planning, local companies have no choice but to begin contingencies for a hard Brexit. Overseas stakeholders are also starting to distance themselves from a UK still unable to commit to a post-2019 relationship with the EU27.

United Kingdom Brexit

LSP Scoops $330m For New Medtech Investment Fund

Around 15 medtech companies will benefit from a new $330m fund that has just been raised by investment group LSP. This fund is said to be the biggest in Europe dedicated to medtech.

Financing StartUps and SMEs

Edwards Adds To Wide Range Of Approaches To Mitral Repair

Harpoon is a minimally invasive surgery device that complements Edwards pipeline of transcatheter mitral and septal valve repair and replacement technologies, which now includes at least six technologies at various stages of development, and is one of the company's top R&D priorities.

M & A Cardiology

Harpoon Finds Its Whale: Edwards Spends Up To $250m For Beating-Heart Mitral Repair Option

Edwards Lifesciences exercised a 2015 option to buy Harpoon, a spin-off from the University of Maryland's School of Medicine, for $100m up-front and up to $150m more in milestones, to add Harpoon's beating-heart mitral valve surgery technology to its growing pipeline of transcatheter and surgical mitral valve repair and replacement devices. The deal also validates the investing approach of Epidarex Capital, one of Harpoon's early investors, which looks for early-stage medtech opportunities in the Mid-Atlantic states.

M & A Cardiology

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Global Approvals Analysis: Eight Brain Device Approvals Mark Neurotech November

Medtech Insight's Approvals Tracker reports 22 medical device approvals from outside the United States in November, including 12 CE marks from Europe, plus approvals from Taiwan, Singapore, Japan, India, Canada, Australia and Argentina.

International Approvals Innovation

Mainstay Medical Reaches Milestone With Interim Results Of US Clinical Trial

Mainstay Medical is making steps towards the US commercialization of its neurostimulation system ReActiv8. The company announced a positive outcome from interim analysis of its US ReActiv8 B clinical trial which aims to gather data in support of an application for pre-market approval from the US FDA.

Neurology Clinical Trials

Start Up Spotlight: Thyncing Twice About Psoriasis

Bioelectronics company Thync is gearing up for more clinical trials in 2018 to demonstrate the benefits of its neuromodulation platform for treating psoriasis. The Silicon Valley startup currently sells its wearable device to treat anxiety, stress and improve sleep.

Dermatology Start-up Spotlight

New Data Validates Myriad's myRisk Hereditary Breast Cancer Test, Enhanced With riskScore

Results of a 1,617-patient trial, presented at the 2017 San Antonio Breast Cancer Symposium on Dec. 6, show Myriad Genetics' riskScore test, which combines data from the traditional Tyrer-Cuzick model with 86 single nucleotide polymorphisms can predict the five-year and lifetime risk of breast cancer compared to the Tyrer-Cuzick model alone.

In Vitro Diagnostics Cancer

Starts & Stops: Mercator Looking To Leap Into New Indications For Bullfrog Micro-Infusion Drug-Delivery

Starts & Stops is a regular feature highlighting Medtech Insight's monthly editors' picks of noteworthy medtech clinical trial announcements, initiations, completions, and suspensions. This month's edition, covering November, is led by a major milestone for Mercator Medsystems, developer of the Bullfrog micro-infusion catheter.

Clinical Trials Starts & Stops

QUOTED. Dec. 5, 2017

Check out what Dan Heller, cofounder and CEO of Two Pore Guys, had to say about the firm's digital, hand-held single-molecule biosensor that detects molecules of any type, including viruses, bacteria, antibodies and pathogens.
Quoted StartUps and SMEs

FDA Updates IDE Guidance Addressing Medicare Coverage

CMS may have an easier time determining when it should pay for an investigational device as FDA revamps its IDE device-classification scheme.

Medical Device Policy
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