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Trump Signs 2019 US Federal Funding Bill, Stopping Another FDA Shutdown; CDRH Sees $69M Boost

US FDA’s device center gained a total of $471.4m in budget authority, plus more than $200m that Congress authorized in user-fee funding for the current fiscal year, in a 2019 federal agency spending package signed into law Feb. 15 by the president that prevented a second agency shutdown. The $471.4m budget is roughly $69m more than was given to CDRH for FY 2018.

United States FDA Legislation

Breast Surgeons Advise All Breast Cancer Patients Be Offered Genetic Testing

The American Society of Breast Surgeons published new guidelines, recommending that genetic testing should be made available to all patients with a history of breast cancer. The new recommendations are not in line with existing guidelines made by the National Comprehensive Cancer Network.

Cancer In Vitro Diagnostics Health Technology Assessment

Vagus Nerve Stim Gets New Chance To Prove Its Worth For Depression

The US Centers for Medicare and Medicaid Services loosened its long-running noncoverage policy for vagus nerve stimulation for treatment-resistant depression a little bit, with a tightly controlled coverage-with-evidence-development policy. Device-maker LivaNova hopes to launch a Medicare-covered study later this year.

Market Access Reimbursement Policy

Trade Group Suggests New Guidelines On Imaging Device Servicing, Remanufacturing

A new white paper from the Medical Imaging & Technology Alliance suggests ways US FDA could better distinguish between imaging device servicing and remanufacturing. The agency has previously announced plans to clarify the difference.

Manufacturing Safety FDA

QUOTED. Feb. 15, 2019. Larry Biegelsen.

Johnson & Johnson announced it will acquire robotic startup Auris Health for $3.4bn in cash, plus up to $2.4bn in milestones. See what Wells Fargo analyst Larry Biegelsen wrote about it here.

Quoted Deals Surgery

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Pulse Of The Industry 2018: How Medtechs Will Create Value In The New Health Ecosystem

In the 12th edition of EY’s medtech report, The Pulse of the Industry, they examine the annual performance of the medical device industry in the context of the technological advances and rising customer expectations associated with the Fourth Industrial Revolution. To thrive in this transformative age, medtechs must adapt their business models to meet the increased expectations of consumers and other health care stakeholders.

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Policy & Regulation Explore this Topic

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FDA Draft Guidance Outlines Agency's Plan To Offer Nonbinding Feedback On Form-483 Observation Resolutions

Device manufacturers would be able to get nonbinding feedback on their plans for how to resolve some Form-483 inspectional observations from US FDA officials under a new draft guidance released Feb. 15.

Guidance Documents FDA Enforcement

US FDA Advisory Committee Recommends 3-Year Benefit-Risk Reviews For Pelvic Mesh

An FDA advisory committee recommended Feb. 12 that US FDA take up to three years to assess the benefits and risks of pelvic mesh, and that product labels call for experienced surgeons only for implantations, if any new mesh products for transvaginal repair of pelvic organ prolapse (POP) are approved. Meanwhile, public-health groups said ongoing PMA applications for current mesh products should be rejected, given the large number of reoperations and adverse events associated with the use of mesh.

Advisory Committees Safety Regulation

Canada Lays Out Rules On Device Importation

Health Canada has published a guide for manufacturers planning to import medical devices into the country. New procedures and advance notice are required under the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), which Canada ratified in 2018.

Canada Medical Device

Software: Australia Plans Reforms While Canada Consults On Guidance

Australia is proposing to introduce new medical device software rules that would result in a number of changes for industry. Health Canada, meanwhile, has developed a draft guidance for software as a medical device to better define the regulatory compliance requirements for emerging technologies.

Canada Australia

New Device Tax Repeal Bills Are Coming, With Candidate Klobuchar's Help

Despite a recent report that Sen. Amy Klobuchar, D-Minn., is backing away from leading efforts to repeal the medical device tax due to her presidential ambitions, sources say she is working with Sen. Pat Toomey, R-Pa., to cosponsor a repeal bill this year. Similarly, on the US House-side, Rep. Ron Kind, D-Wisc., is calling on his colleagues to support a full repeal bill as well.

Legislation Lobbying

One In Three Medtech Innovators Will Be 'Driven Out Of Business' By EU MDR, German Business Survey Finds

The EU Medical Device Regulation is 15 months away from being implemented in full, and a new German survey about its potential impact on the medtech innovation and patient-care landscape makes for sobering reading.

Germany EU

QUOTED. Feb. 13, 2019. Pavan Choudary.

India is now allowing medical device companies to submit their instructions for use (IFU) in electronic format. See what Pavan Choudary from the Medical Technology Association of India said about it here.

Quoted Policy & Regulation

Warning Letter Roundup & Recap – Feb. 12, 2019

No device-related warning letters were released by US FDA the week of Feb. 12.

Device Warning Letters FDA

Quality Control & Compliance Explore this Topic

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Medtech Tips: First-Rate Problem Statement Key To Failure Investigations, Cardinal Health Quality VP Says

A clear, succinct problem statement is the backbone of a winning device failure investigation, Karl Vahey says. He notes that a well-developed statement is also useful to have on hand when regulators conduct a facility audit and review corrective and preventive action (CAPA) activities.

Medtech Tips Quality

Implant-Makers Can Get A Leg-Up On Safety With New Standard From ASTM International

The upcoming voluntary global standard F3306 aims to improve the safety of surgically implanted medical devices. F3306 describes a novel test method that assesses metal and other ions released from single-use, metallic, implantable devices, and their components.

International Standards

Q4 Recalls Snapshot: Recalled Device Units Soar 449%; Bad Software Leading Recall Cause For 11th Quarter In A Row

While the number of recalled products fell 1% in the fourth quarter of 2018, the number of recalled device units spiked dramatically. Machine failure was the top recall cause based on units, while software was blamed for causing the most recalled products for the 11th consecutive quarter. Check out our Q4 recalls infographic.

Recalls Safety

Commercial Explore this Topic

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MDx Health Signs Exclusive Canadian Agreement

MDx Health has signed an exclusive distribution deal to make its liquid biopsy prostate cancer test available in Canada.

Canada Cancer Commercial

QUOTED. Feb. 14, 2019. Trish Costello.

Frost & Sullivan expects the "Femtech" market to reach $50bn by 2025. Reproductive health and menstrual health trackers rank among the fastest-growing sectors. See what Portfolia's Trish Costello said about it here.

Quoted Market Intelligence

Abbott Unit Aims To Settle Investor Suit

Thoratec has agreed with plaintiffs to pay $12m to settle a lawsuit alleging the company hid negative information about the company’s heart pump, thus keeping share prices artificially high. A hearing is scheduled on the settlement for next month.

Legal Issues Commercial

Start-Up Spotlight: Cognoa Seeks Breakthrough In Early Diagnosis Of Autism And ADD

US FDA recently granted Cognoa’s autism diagnostic device a Breakthrough Device designation to accelerate its efforts to get the first FDA-cleared medical device for the early diagnosis of autistic spectrum disorder (ASD) to market. The average age of ASD diagnosis is about four years old, but extensive clinical research has shown that earlier diagnosis of ASD can improve outcomes over the child’s lifetime. Cognoa’s system is intended to allow primary care physicians to diagnosis ASD in the children as young as 18 months.

Starts & Stops Diagnostics

Execs On The Move: C-Suite Changes at Nuvectra, Biogennix, Microbot

An experienced board member steps up to fill the CEO slot at neurostim firm Nuvectra; a new CFO is taken on board at osteobiological products company Biogennix; and Microbot Medical's chief operating officer resigns.

Appointments Commercial

Market Intel: Let's Talk About It — The Rising Tide Of 'Femtech' Companies

Femtech, which describes digital technologies that aim to improve women's health, is expected to reach $50bn in market size by 2025, according to Frost & Sullivan. Reproductive health and menstrual health trackers are two of the fastest-growing sectors in femtech. We've highlighted some of the biggest players in both segments, their innovative business models, plans and also looked at barriers such as privacy issues, accuracy of mobile applications and funding challenges.

Market Intelligence Commercial

Edwards Lifesciences Buys CAS For $100M

Edwards Lifesciences has made its first acquisition since 2017, inking a $100m deal to buy monitoring technology company CAS Medical Systems.

M & A Deals

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Device Week, Feb. 13, 2019 –  Femtech Draws Investment; Smith & Nephew/Nuvasive Merger Rumors Emerge

In this edition of Device Week, Medtech Insight’s Reed Miller talks to managing editor Marion Webb about the growing interest among investors in "femtech," technology that specifically addresses women's health issues that have been frequently overlooked in the past. And London-based reporter Catherine Longworth addresses the recent media reports that Smith & Nephew may make a bid for spine-device company Nuvasive.

Device Week Business Strategies Clinical Trials

Global Device Approvals, Weekly Snapshot: Spine Device Duo

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, two spine device approvals from US FDA, and a CE mark for a new drug-eluting stent.

Approvals Research & Development

Results Recap: Personal KinetiGraph Provides Useful Information On Parkinson’s; Leviticus’ Wireless LVAD Power System Shows Promise In First Patients

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering Feb. 1 through Feb. 10, includes published results from trials of Global Kinetics’ Personal KinetiGraph movement recording system for Parkinson’s disease patients, Milestone Scientific’s CompuFlo Epidural System for epidural-block anesthesia, and Leviticus Cardio’s wireless Coplanar Energy Transfer system for left-ventricular assist devices.

Tracking Trials Research & Development

Impella Fails To Improve Mortality In Non-Randomized STOP-SHOCK

Results of a study published in December found that left-side circulatory support with an Impella pump was not associated with lower 30-day mortality compared with matched cardiogenic shock patients treated with an intraaortic balloon pump (IABP) or medical therapy.

Clinical Trials Research & Development

Abiomed, FDA Attribute High Mortality In Impella RP Post-Market Data To Patient Selection

FDA sent a letter to physicians alerting them to interim results from the post-approval study of Abiomed’s Impella RP right-heart pump system that suggest a higher mortality rate for patients than what was observed in pre-market studies. FDA believes the benefits of the Impella RP system continue to outweigh the risks for patients covered by the currently approved indication; it emphasizes to physicians the importance of early placement of Impella RP, and the importance of following proper inclusion and exclusion criteria when selecting patients. The results cited by FDA were announced about two months after results of a non-randomized study in Germany cast doubt on the benefits of Impella for left-sided support in cardiogenic shock patients.

Clinical Trials FDA

US FDA Panel Meeting Set For Alzheimer’s Device Treatment

An Alzheimer’s treatment device from Israeli firm Neuronix Ltd has landed a date with US FDA’s Neurological Devices Panel. The committee will discuss the neuroAD Therapy System on March 21.

Advisory Committees Research & Development

Results Recap: RESCUE Shows Medtronic Valiant Captivia Stent Graft Treats Blunt Thoracic Injury

This week's edition of Medtech Insight's Results Recap, the weekly roundup of major device trial results from MedDeviceTracker, includes medical device trial results announced from Jan. 25 through Jan. 31. After a flood of data last week from the Leipzig Interventional Course (LINC), this week’s list has just two entries: Medtronic announced new results supporting the long-term durability, safety, and efficacy of its Valiant Captivia thoracic stent graft system for the treatment of blunt thoracic aortic injury and Levita Magnetics announced the publication of a retrospective review of 73 bariatric procedures with its Levita magnetic surgical system.

Tracking Trials Research & Development