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Featured Stories


VC Deals Analysis: Could 2017 Smash $6bn Barrier?

November may have had the lowest deal volume of the year to date, but five hefty fundraisings pushed the total takings of the first 11 months of 2017 to more than $5.9bn. With one more month to go, will 2017 succeed in surpassing $6bn in total deal value, and claim the title of most bountiful year since 2013?

Financing StartUps and SMEs Deals

MTI 100: Medtronic Still Leads, While M&A, Strategic Moves Elevate Others

After knocking Johnson & Johnson off its long-held top position last year, Medtronic has successfully retained the lead in the global medtech market for the second year running in Medtech Insight's MTI 100 rankings. Meanwhile, movement and reshuffling in the ranks continued among other top-tier industry players as they reaped the rewards from previous M&A deals and long-term growth strategies. In this article, we take a closer look at the top-10 overall players, and see who's leapt in front of rivals and who's left eating dust in Medtech Insight's 2017 edition of its annual ranking.

Medical Device Commercial Companies

New Path For 510(k)s On US FDA's FY 2018 Guidance-Priority Plan

FDA intends to draft a guidance by March outlining a voluntary, alternative 510(k) pathway for sponsors to demonstrate the substantial equivalence of some products by relying more on objective performance criteria.

Regulation United States Medical Device

QUOTED. Dec 12, 2017. Natalie Moll.

Check out what the European Federation of Pharmaceutical Industries and Associations' Natalie Moll had to say about life-science industry alignment on Brexit.
Brexit Medical Device In Vitro Diagnostics

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Policy & Regulation Explore this Topic

Set Alert for Policy

Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need Some Work

US FDA dropped three big digital-health guidances related to medical software as part of its initiative to help to streamline a path to market for a sector that is "increasingly embraced" by the health system and needs regulatory certainty, according to agency. But initial industry reaction to perhaps the most highly anticipated of the document, on clinical-decision-support software, is somewhat critical.

Regulation Digital Health Innovation

Planned US Device-Center Reorg Will Be Organized Around Device Types

CDRH compliance official Sean Boyd described agency plans to group staff in device-specific offices that would handle products from pre-market review through inspections and enforcement. If approved, the reorganization would go forward in 2018.

Medical Device FDA Regulation

US Congress Passes Short-Term Funding, While Debt Ceiling Lingers

Congress managed to temporarily stave off a government shutdown, but a continuing resolution bill passed Dec. 7 gives lawmakers only two more weeks – until Dec. 22 – to come up with a final budget plan for 2018. Meanwhile, a deal to raise the debt ceiling, allowing more spending next year, still needs to be set.

Legislation United States

US FDA's Gottlieb Takes Digital Device Questions From Senators At Cures Hearing

The commissioner explained to senators he is trying to go beyond the 21st Century Cures Act to further encourage development of innovative digital devices.

Digital Health Policy & Regulation

Will Brexit Negotiations Move To Devices Soon?

It's been a long and painful journey, but some progress has finally been made in Brexit talks. It is looking hopeful now that a "hard Brexit," or no-deal Brexit, is unlikely. Is there more good news coming for devices?

Brexit Medical Device

Medtech-Supporter Sen. Al Franken To Resign, After Harassment Charges

Sen. Al Franken, D-Minn., who has championed key device regulatory reform changes favoring the medtech industry that are now law, will step down from his post, following newly revealed charges of sexual harassment by a former congressional staffer in 2006.

Policy & Regulation Leadership

EMA Warns Device Sector That Relocation Could Hinder Device Approvals

The EMA does not just regulate drugs. It plays a vital role with some drug/device combination products and borderline products. Just as that role is expanding, relocation threatens to cause a hiatus for device-type products.

Europe Medical Device

Shuren: More Than A Dozen MDDTs Under Review, But No More This Year

The head of US FDA's device center says there are a substantial number of medical device development tools under review by the agency that could help speed up data collection for product approvals and clearances, but they are not likely to be OK'd by the agency until next year.

Regulation Clinical Trials

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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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 Cardiovascular Cardiology

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

QUOTED. Dec. 11, 2017

Check out what MedTech Innovator CEO Paul Grand had to say about why it's important for his nonprofit group to fill the funding gap for early-stage medical device companies.
Quoted Commercial

Stryker Expands ENT Breadth With $600m-Plus Deal

The orthopedic giant is acquiring Entellus Medical for $24.00 per share, adding to its ear, nose and throat device portfolio with Entellus platforms including XprESS multi-sinus dilation system and the Latera absorbable nasal implant.

Deals Commercial

QUOTED. Dec. 8, 2017

Check out what Simon-Kucher & Partners' Joerg Kruetten had to say about companies that claim digital sales tools don't impact their business much.
Quoted Business Strategies

M&A Analysis: M&A Loses Momentum In November

M&A activity tumbled in November after October's big boom. Nine deals were recorded on Medtech Insight's M&A Deal Tracker, repeating the low deal count seen in the same period last year. However, the month saw a handful of notable deals, including Philips' eighth acquisition of the year.

M & A Deals

UK Life-Sciences Sector Deal Brings Life And Funding To Industrial Strategy

The next step in the UK government's life-science strategy, the Life Sciences Sector Deal, was issued today, setting out a blueprint of government-support mechanisms and private investment across the whole of the sector. The deal, signaled yesterday at UK HealthTech 2017, seeks to maximize the potential of medtech and pharma businesses, and exploit the value of the NHS.

United Kingdom Market Access

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

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 Research & Development

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

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

Start-Up Spotlight: Two Pore Guys, Gearing Up To Market Unique Handheld Nanopore Sensor After Inking Agreement With Monsanto

Two Pore Guys has developed a digital, hand-held single-molecule biosensor capable of detecting a wide array of molecules including viruses, bacteria, antibodies and pathogens. The company plans to market the point-of-care device in mid-2018 and already has inked agreements with human diagnostics, animal health companies and agribusiness giant Monsanto Co.

Start-up Spotlight StartUps and SMEs

US FDA Approves Device To Aid Cataract Patients

Approved by US FDA on Nov. 22, a new intraocular lens from RxSight is designed to correct residual refractive errors after cataract surgery and enable clearer vision.

Ophthalmology Approvals
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