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UK Medtech Market Access: More About Mindset Than The Money

The journey from medtech concept to implementation is long and slow, and new ideas often don’t make it all the way to manufacturing and approval. But when they do, what is needed is a system that guarantees adoption and usage of those proven, innovative solutions that clear the many hurdles en route to clinical practice.

Medical Device United Kingdom Market Access

Growing Pressures In Medtech Drive Consideration Of Innovative Pricing Models

Factors including hospital consolidation and increasing price transparency bring growing pricing pressure to medtech manufacturers. In this context, more manufacturers are considering new approaches to value-based pricing to maximize opportunity while minimizing risk, according to this expert column from CRA's Matthew Majewski and Kira Gordon.

Pricing Strategies Pricing Debate Commercial

Starts & Stops: CardioFocus Studies HeartLight X3 In Persistent AF; IntraLink Spine Launches Trial Of Low-Back Device In Australia

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from March 4 through March 17, including trial announcements from CardioFocus, Innovative Cardiovascular Solutions, IntraLink-Spine, Geneveve, Acutus, and Stereotaxis.

Starts & Stops Tracking Trials Clinical Trials

Fixing Reimbursement ‘Valley Of Death’ And Repealing The Device Tax Are Top MDMA Priorities, CEO Leahey Says

In an interview about medical device lobbying priorities, the Medical Device Manufacturers Association CEO Mark Leahey talked about efforts to figure out administrative and potentially legislative solutions to gain reimbursement for products sooner after FDA approval. Leahey also argues industry groups are in a better position to permanently repeal the 2.3% medical device excise tax despite previous failures to do so.

Legislation Policy Reimbursement

QUOTED. March 18, 2019. Cisco Vicenty.

US FDA is approving 30-day change notices at a breakneck pace for device-makers enrolled in an agency program that measures manufacturing maturity and quality. See what FDA's Cisco Vicenty said about it here.

Quoted FDA Manufacturing

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Policy & Regulation Explore this Topic

Set Alert for Policy

FDA Will Hold Advisory Panel Meeting In Fall On Metal Implant Reactivity

US FDA Commissioner Scott Gottlieb and device center director Jeffrey Shuren reminded the public on March 15 that materials in devices – including metals in orthopedic products and defibrillators – can cause reactions in some patients. They said the agency needs to do "more work” on patient responses to metal implants and other biomaterials, and announced an FDA advisory panel meeting this fall on reactions to metals.

Regulation Safety Advisory Committees

Brazil Simplifies Class I Approvals To Focus On Higher-Risk Products

Brazil has passed legislation enabling class I (lowest risk) devices and diagnostics to gain market approval through a notification pathway rather than under the current review-based registration system. The move is essentially intended to help regulatory agency Anvisa refocus its efforts toward the higher-risk arena.

Brazil Medical Device Regulation

FDA Says It's Approving Change Notices 3 Weeks Faster For Firms In CMMI Maturity Model Program; 40+ Inspections Waived

The US agency is approving 30-day change notices at a breakneck pace for device-makers enrolled in an ongoing program that measures manufacturing maturity and quality using an industry-modified version of the Capability Maturity Model Integration (CMMI) framework. FDA also says it has waived 40 routine and four pre-approval inspections as part of the program – a help not only to device firms, but to the agency as it considers where best to use its scarce inspectional resources.

FDA Manufacturing

EU No-Deal Still Haunts UK Medtechs As Brexit Remains On A Knife Edge

The UK is the middle of a week of Brexit votes in Parliament, but confusion for medtechs and the wider industrial community has not been quelled at all, regardless of two days of voting already, and a third to come today.

Medical Device United Kingdom

Canada Launches Portal To Proactively Disclose Clinical Data On Approved Devices, Drugs

Following in the footsteps of the European Medicines Agency, Canada has launched a publicly-accessible portal to proactively disclose clinical trial information on approved medical devices and drugs that was hitherto considered confidential.

Canada Clinical Trials

AdvaMed Pins Hopes For Device Tax Repeal On 10 Senate Democrats, But Could Lose House Support

A coalition of 27 Senators – including 10 Democrats led by Amy Klobuchar, D-Minn. – on March 7 co-sponsored a bill to permanently repeal the device tax. AdvaMed says support of additional Democrats on this year’s bill should persuade Senate leaders to bring S. 692 to the floor for a vote, or it could be attached to other, "must pass"’ legislation. But the bill’s approval in the Democratic-controlled House is uncertain. Sixty-five of 283 “yes,” voters – mostly GOP – favoring tax repeal in the last session, are no longer in office.

Legislation United States

QUOTED. March 13, 2019. Alex Azar.

Norman "Ned" Sharpless, director of the National Cancer Institute, will lead US FDA as its acting commissioner when agency head Scott Gottlieb steps down next month. See what Health and Human Services Secretary Alex Azar said about the appointment here.

Quoted FDA

HHS Secretary Azar Takes Heat At Budget Hearing

HHS Secretary Alex Azar was pressed on issues tied to the Affordable Care Act and the recently proposed FY 2020 budget at a March 12 congressional hearing.

Legislation Reimbursement

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

FDA Says It's Approving Change Notices 3 Weeks Faster For Firms In CMMI Maturity Model Program; 40+ Inspections Waived

The US agency is approving 30-day change notices at a breakneck pace for device-makers enrolled in an ongoing program that measures manufacturing maturity and quality using an industry-modified version of the Capability Maturity Model Integration (CMMI) framework. FDA also says it has waived 40 routine and four pre-approval inspections as part of the program – a help not only to device firms, but to the agency as it considers where best to use its scarce inspectional resources.

FDA Manufacturing

FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks

The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.

Quality Control Safety

California Company Surprised After Getting Slammed By US FDA For Marketing Of Imaging Device

Total Thermal Imaging, a company that promotes thermal imaging technology over mammography to detect breast cancer, says it is surprised the agency is coming after them for "illegally marketing" their test for unapproved indications. The company says it thought it had complied with all of FDA’s requirements but  is willing to consider filing a 510(k) if needed.

Quality Control Regulation

Commercial Explore this Topic

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Functional MR Added To FDA-Approved Indication For Abbott's MitraClip

The new indication covers functional mitral regurgitation, also known as secondary mitral regurgitation, which represents two-to-three times as many patients as the primary mitral regurgitation population MitraClip is already labeled for. The approval is supported by results from the COAPT trial, the first randomized trial to show that a mitral-valve repair could improve outcomes in patients with secondary mitral regurgitation.

Approvals Commercial Companies

QUOTED. March 15, 2019. John Russell.

Cardiva Medical believes it's in a unique position to help the growing number of patients who undergo catheter-based cardiovascular procedures requiring relatively large catheters, especially electrophysiology procedures like cardiac ablation. See what Cardiva CEO John Russell said about EP procedures here.

Quoted Commercial

Device Week, March 14, 2019 – Smith & Nephew Boosts Wound Care Biz; Key Cardiac Trial Results At March Meetings

In this edition of Device Week, Medtech Insight’s Catherine Longworth discusses Smith & Nephew’s $660m acquisition of regenerative medicine company Osiris Therapeutics. And Reed Miller talks about the clinical trial highlights from the recent CRT Meeting in Washington and looks forward to the American College of Cardiology conference next week.

Device Week M & A

QUOTED. March 14, 2019. Mika Wang.

The current annual global manufacturing market for liquid biopsy is roughly $170m – representing a 90% yearly increase since 2015 – and it's expected to reach about $1bn by 2023. See what DeciBio Consulting's Mika Wang said about it here.

Quoted Commercial

Cardiva Forsees ‘Room To Run’ For Its Unique Vascular Closure Devices

Cardiva Medical is taking advantage of the growing demand for products that safely and quickly close the access sites created for catheter-based electrophysiology procedures and other large-catheter cardiac procedures. The company has a sales staff entirely dedicated to its line of closure devices for multi-site venous closure for 6-12 French inner diameter sheaths, and is investing in clinical trials to show how these devices can improve patients’ recovery time and reduce the risk of complications.

Commercial Clinical Trials

Execs On The Move: Operations Change At Misonix, A Switch From Medtronic Diabetes, And New Advice At DBV Technologies

Ultrasonic surgical platform firm Misonix appoints chief operating officer; a chief marketing officer leaves Medtronic for a place at continuous glucose monitoring system company Senseonics; food allergy biopharma firm DBV Technologies adds a scientific advisor; and more.

Appointments Commercial

AAOS 2019: OSSO VR Develops VR Training Tool For Smith & Nephew's NAVIO Robot, And More On Orthorobotics

Osso VR partnered with Smith & Nephew to develop a VR training tool that will be showcased at this year's American Association of Orthopedic Surgeons' (AAOS) conference, taking place in Las Vegas from March 12-16. Orthopedic robotic systems continue to draw high interest from surgeons. The recent US FDA clearance of Zimmer Biomet's ROSA total knee replacement system will add competition to the current market dominated by Stryker's MAKO and Smith & Nephew's NAVIO.

Commercial Deals

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

AAOS Results Recap: Stryker’s Knee-Surgery Robot And Miach’s New ACL Scaffold

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This is a special edition covering trial data presented during the first three days of the American Academy of Orthopedic Surgeons Annual Meeting, held in Las Vegas March 12-16, including presentations on devices from Stryker, Miach, Myoscience, CyMedica, and Reflexion Health.

Tracking Trials Research & Development Clinical Trials

New Somatic Reference Sample Guide To Aid NGS Test Development

Makers of next-generation sequencing tests often have a hard time finding somatic reference samples to use when developing their products. To help sponsors find those samples, the Medical Device Innovation Consortium with help from US FDA has developed a guide that aggregates reference samples to help validate their tests.

Clinical Trials Personalized Medicine

Results Recap: CRT In DC Features New Biotronik Stent Data, Encouraging TAVR Low-Risk Data; Ablative Systems’ Alcohol Renal Denervation

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering March 1 to March 7, includes results of late-breaking trials presented at the 2019 Cardiovascular Research Technologies (CRT) conference in Washington, DC, including new data supporting Biotronik’s biodegradable polymer sirolimus-eluting stent and the company’s resorbable magnesium stent, results of the LRT trial of transcatheter aortic valves in low-risk patients, plus promising clinical data supporting Ablative System’s alcohol renal-denervation system.

Tracking Trials Clinical Trials

Drug-Coating Safety Risk Acknowledged At Cardiology Gathering, But Cause Remains Elusive

Physicians and researchers in an all-day session at the Cardiovascular Research Technologies conference in Washington, DC, on March 5 largely backed the recent finding that paclitaxel-coated balloons and stents may be tied to a higher patient mortality rate. But the specific mechanism underlying the deaths remains unknown.

Safety Research & Development

Global Device Approvals, Weekly Snapshot: Hemodialysis Stent, Spine Device, Bleeding Monitor

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, Vertos Medical gains a CE mark for its spine stenosis procedure kit, and US approvals for BD and Saranas.

Approvals Research & Development

Starts & Stops: First-In-Human Trial Of RaniPill Drug-Delivery Device Begins

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by MedDeviceTracker. This edition covers Feb. 25 through March 3. Rani Therapeutics announced the first-in-human experience with its novel drug-delivery capsule Feb. 28.

Starts & Stops Tracking Trials

Results Recap: Support For Medtonic's 'Suspend Before Low' Insulin Pump Feature; Neuroelectrics' Starstim Treats Epilepsy Seizures

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering Feb. 22 through Feb. 28, includes published results from trials of Medtronic’s closed-loop artificial pancreas, Neuroelectrics’ nerve stimulation device to treat seizures, and Myriad’s companion diagnostic for pancreatic cancer.

Tracking Trials Research & Development
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