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FDA Tracks Critical Device Supply During Puerto Rico Hurricane Recovery

Continuing recovery efforts in Puerto Rico have US FDA focused on life-sustaining devices or those only made on the island. Meanwhile, manufacturers including Baxter, Zimmer, J&J and Abbott report varying impacts from the storms.

Medical Device Puerto Rico Commercial

Why Low-Risk And Upclassified Devices Must Heed EU Timeline Warnings

EU compliance deadlines for low-risk devices may be earlier than companies realize. Meanwhile, deadlines for device-types that are being upclassified under the new regulations may mean time pressures, too, for different reasons. Notified body VP Bassil Akra explains in an interview with Medtech Insight.

Europe Medical Device Regulation

Medovex Plans US IDE Trial For Its DenerveX Spine Surgery Device

DenerveX is a unique surgical tool used to ablate the nerve and capsular tissue on the posterior surface of the facet joint. preventing the nerve from reattaching with the goal of creating lasting relief from back pain that otherwise might require spinal fusion and/or treatment with opiate drugs.

Companies Innovation Surgery

Device Week, October 19, 2017 – IVD Updates, And Watchman Scrutiny

On this week's podcast, we highlighted progress by several startups in the molecular diagnostics space, and discussed growing scrutiny in the cardiology community of Boston Scientific's Watchman stroke device.

Clinical Trials Innovation Device Week

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Policy & Regulation Explore this Topic

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FDA Final Guidance On Drug/Device Classifications Misses The Mark, Attorneys Say

The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.

Regulation Combination Products United States

AdvaMed CEO Supports Potential HHS Secretary Nominee Azar

AdvaMed CEO Scott Whitaker says Alex Azar, who is reportedly the top candidate to be nominee for US Health and Human Services secretary, would be ideal for the job with his extensive experience at the department.

Policy Medical Device United States

Industry Asks CMS To Allow More Medtech Input, Longer-Term Metrics In Bundled Pay Models

Industry groups told the US Medicare agency it should seek the input of a broader array of stakeholders – including medtech companies – in developing future episode-of-care pay models. They also argued that participation in the programs should be voluntary, and that the pay models should account for patient outcomes longer than 90 days following initial care. The responses came in comments to CMS following its proposal to scale back its joint replacement bundled payments program and eliminate a cardiac-care version.

Reimbursement Market Access

Latest On EU's MDR/IVDR Implementation Road Map

October 19 came and went without release of the EU's official road map, which will act as a catalyst for work intended to support implementation of the new EU medtech regulations. So how much longer before it is public?

Medical Device Europe

Minnesota Lobby Group Hires Top State House Staffer

The Medical Alley Association hired the former Minnesota House Speaker's legislative director Bobby Patrick to lead lobbying efforts in the state.

Policy Medical Device

EU Commission May Open Floodgates By Inviting Input On Editorial Errors

The European Commission is planning to invite comments on editorial mistakes within the EU's new medtech regulations. But will it get more than it is bargaining for?

Europe Medical Device

Crucial EU Meeting Oct. 18 To Set Out MDR/IVDR Implementation Work

Implementation of the EU's new highly-detailed Medical Device and IVD Regulations will greatly challenge EU regulatory groups. The work plan signposts the direction ahead, but it will be resource-hungry.

Medical Device Europe

FDA Calling: US Agency Again Asks Companies To Open Doors For Educational Purposes

In its continuing bid to better understand how industry and other stakeholders operate in the real world and learn to improve its own practices, FDA is again asking volunteers to let staffers come observe organizations for a day or two as part of the device center's Experiential Learning Program.

Regulation FDA

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Many Firms Use Old-Fashioned Complaint Handling Tactics, Survey Finds

A recent study by Sparta Systems revealed that more than four in 10 companies, including device-makers, still primarily handle customer complaints on paper, or via a decentralized system like Microsoft Excel or Access. Two quality assurance experts weigh in.

Quality Control Compliance

FDA Looks For Diverse CMMI 'Maturity' Pilot Enrollees; Device-Makers Expect Big Savings

The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program – designed to gauge the manufacturing maturity of device-makers – to smaller firms, officials said at a recent industry meeting. Medtronic and Edwards Lifesciences, in particular, noted that using the Capability Maturity Model Integration (CMMI) appraisal framework could allow them to save hundreds of thousands of dollars in FDA submissions and 30-day notice fees, among other expenses.

Quality Control Compliance

'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover

CDRH Director Jeff Shuren told industry that the device center is moving quickly to establish a "super office" to tackle the full spectrum of pre- and post-market issues to reduce inefficiencies to replace the more siloed approach. Chief Scientist Bill Maisel has already been named a director.

Regulation FDA

Commercial Explore this Topic

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Will AAA's Nuclear Med Offerings Turn M&A Buzz Into A Deal?

Advanced Accelerator Applications (AAA) has hit the headlines with recent rumors of a potential acquisition deal from Novartis. Now that the radiopharmaceutical company has its first therapeutic product approved and ready for commercialization, is AAA really ready to sign the dotted line?

Cancer Companies Commercial

Latest From Commercial

NuVasive, Alphatec At Odds Over Exec Job Change

NuVasive has sued a former executive and board member for breach of contract after his move to competitor Alphatec. The smaller company says the basis of the lawsuit is “fictional.”

Medical Device Legal Issues

Novacyt Raises €9.7M, Ahead Of UK IPO

Clinical diagnostics firm Novacyt has raised €9.7M from UK and French investors ahead of plans to dual list on the London Stock Exchange Alternative Investment Market (AIM). The Cambridge, UK-based company is currently listed on the Euronext Growth Paris exchange.

Diagnostics In Vitro Diagnostics

Teamsters Ask Stockholders To Replace Cardinal Health Chairman

The International Brotherhood of Teamsters say that Cardinal Health CEO George Barrett failed to set the correct "tone at the top" while the firm became embroiled in the opioid epidemic and allegedly overpaid its chief compliance officer for illicit sales. The group is asking shareholders to appoint an independent board chairman, stripping Barrett of the role.

Commercial Appointments

Change At Helm As Tissue Regenix Enters Next Growth Phase

Regenerative medicine firm Tissue Regenix is now seeking a new CEO following the departure of Anthony Odell. The change in leadership comes two months after the company made its maiden M&A deal, acquiring CellRight Technologies.

Regenerative Medicine Companies

genedrive Signs Sysmex To Distribute Decentralized-Setting HCV Test

Molecular diagnostics company genedrive has signed a distribution agreement with Sysmex Corporation to distribute its CE-marked HepC (HCV) ID kit and Genedrive platform in the Europe, Middle East and Africa. The Japanese group is the first commercial partner for genedrive's hepatitis C test for decentralized resource-limited settings.

Commercial Medical Device

Device Designed To Improve Spine-Surgery Outcomes Gets FDA Panel Date

US FDA says its Orthopaedic and Rehabilitation Devices Panel will convene Dec. 12 to weigh issues surrounding ongoing review of Intrinsic Therapeutics' PMA for its Barricaid anular closure device, intended to close a hole created by a spine discectomy procedure to prevent negative outcomes.

Advisory Committees Approvals

Clinical R&D Explore this Topic

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Start-Up Spotlight: Indi, Liquid Biopsy To Rule Out Lung Cancer

Having secured Medicare reimbursement, Seattle, Washington-based Indi Diagnostics, Inc. is getting ready to bring its liquid biopsy molecular test to pulmonologists in the US starting Q1 2018. The company said it will be first to introduce a liquid biopsy molecular diagnostic test in the country designed to help pulmonologists identify lung nodules that have a high probability of being benign, saving patients unnecessary invasive procedures.

Cancer In Vitro Diagnostics StartUps and SMEs

Latest From Research & Development

Start-Up Spotlight: Lumicell, Shining The Light On Real-Time, Intraoperative Tumor Detection

With its coffers topped up and a new CEO in place, Lumicell is forging ahead with clinical trials of its LUM real-time, cancer imaging system, designed to improve the outcomes of surgical resection of tumors. The company's first target indication is for breast cancer and it is aiming for a US premarket approval in late Q1 of 2019.

Cancer Diagnostic Imaging

Big Promise For TransEnterix Robotic-Surgery Device, But Probably Won't Undermine Intuitive's Market

FDA's recent clearance of TransEnterix's Senhance System signals broad potential for robotically-assisted surgeries but the device is more likely to grow its own space than compete directly with Intuitive Surgical's daVinci products in many cases, analysts suggest.

Approvals Gynecology & Urology

NIH/Industry Oncology Partnership Aims For Immunotherapy Biomarkers

The US National Institutes of Health will team up with 11 different drug-makers to explore new biomarkers with a vision of precision oncology medicine.

Research & Development Personalized Medicine

OUS Approvals Analysis: Abbott Announces Three Glucose Control CE Marks; iVascular Earns Five Approvals In India

Cardiovascular and diabetes device dominated September's list of medical device approvals from outside the US on Medtech Insight's Approvals Tracker. The 24 non-US approvals in September is below average for 2017, but one more than September of 2016 and keeps 2017 on a track to have about 40% more non-US approvals than 2016.

Approvals Innovation

US Approvals Analysis: Cook Churns Out 510(k)s In Q3

The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the third quarter, and pulling neck-and-neck with perennial leader Medtronic for 2017. Overall, FDA remains relatively steady on 510(k) volumes and is maintaining its accelerated pace of novel-device approvals.

Approvals Innovation

OBD's Epigenetic Biomarker Tech Shows Ethnicity Issue-Free Dx Potential

Recent studies completed by epigenetic biomarker company Oxford BioDynamics have shown the company's platform technology EpiSwitch can diagnose and stage breast cancer and Amyotrophic Lateral Sclerosis (ALS). The Oxford spinout is the developer of a blood-based platform test for detecting chromosome confirmation signatures (CCSs), which overcome any ethinicity issues.

Clinical Trials Companies