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Featured Stories


Physicians Failing To Disclose Supplier, POD Arrangements Fuel Kickback Concerns, Senators Say

US Senate Finance Committee leaders say some physicians may have failed to disclose their physician-ownership interests in entities that offer medical supplies to the physician’s own practice, as required under the Physician Payment Sunshine Act. The legislators on March 19 prodded the Health and Human Services' Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) to take a closer look into these arrangements.

Reimbursement Enforcement Legal Issues

Start-Up Spotlight: Innovative Cardiovascular Solutions Hopes To Win Regulatory Nod For Embolic Protector For TAVR

Transcatheter aortic valve replacement (TAVR) is performed routinely using devices providing protection from stroke as standard of care. However, cerebral embolic protection devices currently available do not capture and remove emboli from all three vessels leading to the brain. The Emblok Embolic Protection System from Innovative Cardiovascular Solutions (ICS) has developed an embolic filter designed to protect all three cerebral vessels during TAVR and remove debris from the entire circulatory system.

Commercial Start-up Spotlight StartUps and SMEs

Beyond Mad Cow: FDA’s Updated Animal Component Guidance Looks To Limit Spread Of More Diseases

US FDA has updated a final guidance on the use of animal components in medical devices. The new version incorporates precautions intended to limit the transmission of a wider range of diseases, while the original focused on bovine spongiform encephalopathy (mad cow) disease.

FDA Guidance Documents Regulation

AAOS Exec Chat: An Insider Look Into DePuy Synthes' Anterior Approach

Scott Zellner, senior director at DePuy Synthes, and orthopedic surgeon Joel Matta, who has been collaborating with DePuy since 2004, have long advocated for the anterior approach to total hip replacement, touting the many benefits of the minimally invasive surgery. Medtech Insight sat down with Zellner and Matta at this year's American Association of Orthopedic Surgeons' (AAOS) conference in Las Vegas to discuss the company's latest technologies designed for the anterior approach to total hip replacement, what's next, and to hear Matta's view on the widely discussed role of robotic-assisted surgeries.

Artificial Intelligence Commercial Exec Chat

Execs On The Move: Duo Of CEOs For Nonin Medical And Contexual Genomics; New Board At ExThera Medical

Patient-monitoring company Nonin Medical and cancer genomics testing firm Contextual Genomics both hired new CEOs; blood-filtering device firm ExThera Medical appointed a scientific advisory board; and more.

Appointments Commercial Medical Device

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Policy & Regulation Explore this Topic

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No Brainer: US FDA Greenlights First Biomarker Software As Medical Device Development Tool For Brain Injury

Developers of medical devices intended to treat traumatic brain injuries may want to consider using an imaging software developed to detect contusions. The product is the third Medical Device Development Tool qualified by US FDA, which means the agency trusts it to output accurate data supporting clinical trials.

FDA Clinical Trials Approvals

Danish Agency Claims A First In Raw Data Analysis

The Danish Medicines Agency says it is about time that EU regulators developed US FDA-style capabilities to analyze raw data so that they can make better use of the opportunities provided by big data. Agency chief Thomas Senderovitz tells Medtech Insight how Denmark is setting up a unique data analytics center for medical devices and drugs without reinventing the wheel.

Denmark Europe Artificial Intelligence

FDA Tells Providers To Limit Use Of Paclitaxel-Coated Stents

New US FDA analysis of paclitaxel-coated devices to treat peripheral arterial disease matches previous reports of an increased death risk tied to use of the devices. The agency is encouraging providers to look to other treatment options while analysis continues.

Safety Medical Device

FDA Focusing More On Safety Of Device Biomaterials, Attorney Warns

Device-makers will have to take a more proactive approach to understanding the safety of biomaterials they use for their implanted devices, and how these materials might affect patients during post-market use, industry attorney Michele Buenafe of Morgan Lewis & Bockius LLP told Medtech Insight in a March 18 interview.

Regulation Safety

Warning Letter Roundup & Recap – March 19, 2019

Two makers of breast implants failed to comply with years-old FDA post-approval study orders, and TEI Biosciences Inc. – an Integra LifeSciences company – ran afoul of the US agency's Quality System Regulation in device-related warning letters released by FDA this week.

Device Warning Letters FDA

Hong Kong Clarifies Rules On Local Responsible Persons To Facilitate Device Listings

Hong Kong has issued new guidance and an updated code of conduct on the roles and responsibilities of entities wanting to be listed as a local responsible person.

Hong Kong Regulation

EU MDR: Swiss Medtechs Count The Cost Of Being Without An MRA

Maintaining barrier-free trade with the EU will save time and money, according to the Swiss medtech industry, which has made its views clear in a recent survey run by Swiss Medtech.

Medical Device Regulation

Global Device Approvals, Weekly Snapshot: FDA Approves Bard’s Venovo Stent; Abbott’s MitraClip Gets Indication-Expansion; Boston Scientific’s Watchman FLX Earns CE Mark

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Bard’s Venovo venous stent system for symptomatic iliofemoral venous outflow obstruction, FDA added functional mitral regurgitation to the approved labeling for Abbott’s market-leading MitraClip, and Watchman FLX, Boston Scientific’s next-generation left-atrial appendage closer earned a CE Mark in Europe.

Approvals Clinical Trials

Quality Control & Compliance Explore this Topic

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Warning Letter Roundup & Recap – March 19, 2019

Two makers of breast implants failed to comply with years-old FDA post-approval study orders, and TEI Biosciences Inc. – an Integra LifeSciences company – ran afoul of the US agency's Quality System Regulation in device-related warning letters released by FDA this week.

Device Warning Letters FDA

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

Commercial Explore this Topic

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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

QUOTED. March 21, 2019. Martin Leon.

In this week's Results Recap, covering trial data from the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, Martin Leon from Columbia University presented results from the PARTNER 3 trial, comparing Edwards Lifesciences Corp.'s balloon-expandable Sapien 3 transcatheter aortic valve system to open valve surgery. See what Martin Leon from Columbia University said about it here.

Quoted Tracking Trials

QUOTED. March 20, 2019. William Mihalko.

In this week's Results Recap covering trial data from the American Academy of Orthopedic Surgeons Annual Meeting in Las Vegas March 12-16, Myoscience released encouraging preliminary results from a 125-patient study on its Iovera cryoanalgesia therapy. See what the presenter of the results, William Mihalko, from Campbell Clinic of Germantown, Tennessee, said about it here.

Quoted Commercial

Global Device Approvals, Weekly Snapshot: FDA Approves Bard’s Venovo Stent; Abbott’s MitraClip Gets Indication-Expansion; Boston Scientific’s Watchman FLX Earns CE Mark

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Bard’s Venovo venous stent system for symptomatic iliofemoral venous outflow obstruction, FDA added functional mitral regurgitation to the approved labeling for Abbott’s market-leading MitraClip, and Watchman FLX, Boston Scientific’s next-generation left-atrial appendage closer earned a CE Mark in Europe.

Approvals Clinical Trials

Boston Scientific Encouraged By Luminize AF First-In-Human Data

Data from the AF-FICIENT I study, presented at the European Heart Rhythm Association in Lisbon, Portugal, support Boston Scientific's development of the Luminize atrial fibrillation ablation catheter. Luminize has built-in digital cameras for visual guidance and sensing electrodes on the balloon to assess real-time vein isolation.

Cardiology Clinical Trials

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

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.

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Clinical R&D Explore this Topic

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ACC Results Recap Part II: CardioMEMS Post-Approval Trial Shows Monitoring Reduces Heart-Failure Hospitalizations; Medtronic’s Tyrx Envelope Reduces Infections

Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the second of three Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including clinical trial data on devices from Abbott Laboratories, Medtronic, Medi-Lynx, and iRhythm. See Part 1 of our ACC Results Recap for more on the groundbreaking trials of transcatheter aortic valve replacement in low-risk patients and the Apple Heart study of Apple Watch's ability to track atrial fibrillation.

Tracking Trials Clinical Trials Research & Development

QUOTED. March 21, 2019. Martin Leon.

In this week's Results Recap, covering trial data from the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, Martin Leon from Columbia University presented results from the PARTNER 3 trial, comparing Edwards Lifesciences Corp.'s balloon-expandable Sapien 3 transcatheter aortic valve system to open valve surgery. See what Martin Leon from Columbia University said about it here.

Quoted Tracking Trials

QUOTED. March 20, 2019. William Mihalko.

In this week's Results Recap covering trial data from the American Academy of Orthopedic Surgeons Annual Meeting in Las Vegas March 12-16, Myoscience released encouraging preliminary results from a 125-patient study on its Iovera cryoanalgesia therapy. See what the presenter of the results, William Mihalko, from Campbell Clinic of Germantown, Tennessee, said about it here.

Quoted Commercial

ACC Results Recap Part I: Low-Risk TAVR Trials Bring Good News For Edwards And Medtronic; Apple Watch Detects AFib In Apple Heart Study

Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the first of three special Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including presentations on Medtronic and Edwards Lifesciences’ transcatheter aortic valves and Apple’s Apple Watch, which now has electrocardiography capabilities.

Tracking Trials Research & Development

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

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

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
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