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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 Innovation

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 Policy & Regulation

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 Quality

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.

Leadership Medical Device Commercial
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Policy & Regulation Explore this Topic

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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 Regulation

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 Quality

AdvaMed CEO Endorses 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

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

Warning Letter Roundup & Recap – Oct. 17, 2017

US FDA issued two device-related warning letters this week detailing quality systems issues at a dialysis supply manufacturer and a facial prosthetics company.

Device Warning Letters Regulation

ASTM Forms Exoskeleton Standards Committee

The standards organization's board of directors approved the formation of a committee that will seek to establish consensus documents for the burgeoning sector.

Standards Policy

Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation

Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.

Advisory Committees Clinical Trials

Harmonization On The Mind: UK MHRA Wants Major Role In Global Regulation

Regardless of the path that the UK-EU Brexit negotiations take, the UK MHRA and the bulk of the local medtech industry are very clear on one thing: The need to retain access to the nascent EU Medical Device and IVD Regulations – and with it, EU reciprocity on device regulation. Any alternative approach is likely to engender unfathomable difficulties and disadvantage for the homegrown UK medtech industry, stakeholders say.

United Kingdom Regulation

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

'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

Quality On The Brain: FDA Maturity Pilot Aims To Shift Industry's Compliance Mentality To A 'Quality Mindset'

An upcoming voluntary pilot program from US FDA will be the perfect vehicle to help drive a compliance-to-quality culture change at medical device firms, developers of the program say. To be stood up early next year, the pilot will see manufacturers use third-party assessors to measure the maturity of their quality systems and manufacturing processes. In a survey, early users of the Capability Maturity Model Integration (CMMI) appraisal process said it helped them identify ways to increase product quality.

Quality Control Compliance

Tossed Aside? Millennials More Likely To Ignore, Throw Out Product Recall Notices, Survey Finds

The survey of more than a thousand consumers shows that manufacturers might want to change the way they interact with people between the ages of 18 and 34 when communicating information about device recalls.

Recalls Quality Control

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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

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

Trump Rollback Of ACA Birth-Control Coverage Mandate To Push Down Gains In IUD Sales

More religious-based college employers, and for-profit businesses with moral objections to contraceptive coverage, will be able to issue health plans denying intrauterine device and birth control coverage to their employees and students starting in 2018, under the administration's Oct. 6-issued "conscience rights" exemptions from Affordable Care Act (ACA) requirements. The interim final rules could dampen sales of IUDs and implants that have risen 5% in the last year at Bayer Healthcare and Allergan.

Gynecology & Urology Market Access

UK NICE’s MedTech Scan Will Give NHS Early View Of Innovation

The UK National Institute for Health and Care Excellence is working on a new database of pre-launch-phase medtech products. The aim is to give NHS providers enough time to plan for the uptake of innovative technologies and, generally, to improve the pathway between development and adoption, says NICE medtech programs director Mirella Marlow.

United Kingdom Market Access

Philips' Profit To Be Dented By FDA-Decreed AED Sales Halt

On signing a consent decree with the US FDA, Philips is halting manufacture and sales of external defibrillators produced at two facilities until the agency is satisfied the company is complying with current good manufacturing practice requirements. The suspension is expected to impact Philips' EBITA for the fourth quarter 2017 and for 2018.

Cardiology Compliance

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

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

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
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