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Heartburn: Yet Another Device-Maker Is Facing Cardiac Device Cybersecurity Worries – This Time, It's Medtronic

Medtronic cardiac devices are vulnerable to malicious hackers who could potentially not only intercept data between the patient and their provider, but also may be able to manipulate the implantable cardiac devices, possibly leading to serious adverse events and death. US FDA says patients should continue to use the devices as usual but should look out for telltale signs of an attack. Meanwhile, Medtronic claims it was aware of the issue and contends that patients shouldn't be concerned: “To date, no cyberattack, privacy breach, or patient harm has been observed," a spokesman says.

United States Cybersecurity Companies

EU Benefit-Risk Guidelines Put Phthalates Safety Back In The Spotlight

The European Commission is seeking comments on preliminary guidelines on how to justify the use of certain phthalates in medical devices.

Safety Regulation Quality

Ibex Medical Raises $11M For AI-Based Pathology Tools

Israeli firm Ibex Medical Analytics has secured $11M in Series A funding, led by aMoon, to expand development of its artificial intelligence applications for cancer diagnostics.

Israel Artificial Intelligence Diagnostics

UK Champions Oxfordshire As Next Global Digital Health Hub

The UK government is championing the region of Oxfordshire to become the next global digital health hub post-Brexit. The ambitious plans to develop the UK’s digital health technologies were outlined at a recent event at the House of Commons in London.

United Kingdom Artificial Intelligence Digital Health

QUOTED. March 25, 2019. R. Kevin Plemmons.

Innovative Cardiovascular Solutions hopes to earn the CE mark and US FDA approval for its Emblok Embolic Protection System. See what the company's CEO, R. Kevin Plemmons, said about the technology here.

Quoted StartUps and SMEs Start-up Spotlight

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Policy & Regulation Explore this Topic

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Unfinished Business: LDT Legislation A Top Priority For Departing FDA Chief Gottlieb

In a farewell talk at the Brookings Institution, outgoing US FDA Commissioner Scott Gottlieb said a top unfinished business that he hopes gets done after his April departure is legislation to regulate laboratory developed tests. While FDA had been looking to issue guidance on LDTs, he argues there isn’t sufficient legal authority for the agency to regulate the sector.

FDA Leadership Policy

Device Week, March 22, 2019 – Goings-On At US FDA

In this week’s podcast, senior reporters Elizabeth Orr and Ferdous Al-Faruque give a quick rundown of FDA goings-on the device industry should keep a sharp eye on, including a reorganization of the Center for Devices and Radiological Health, remarks from outgoing agency head Scott Gottlieb on laboratory developed tests, and news from a recent FDA neurological devices advisory panel meeting.

Device Week FDA Policy

QUOTED. March 26, 2019. Scott Gottlieb.

When soon-to-be-ex-US FDA Commissioner Scott Gottlieb spoke at the Brookings Institution in Washington, DC, on March 20, he displayed great admiration for the job. See what Gottlieb said about his departure from the agency here.

Quoted FDA

Comments Open On Symbols In Device Labeling

US FDA is reopening the comment period on a rule that allows medical device manufacturers to use standardized symbols on product labeling. The docket will be open through May 20.

FDA Policy

Podcast: Gottlieb Addresses LDT Legislation At Brookings

US FDA Commissioner Scott Gottlieb spoke with Medtech Insight about the agency’s decision to put the LDT issue to Congress instead of using guidance-making.

FDA Legislation

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

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

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

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

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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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

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

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

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

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

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

ACC Results Recap Part III: RADIANCE-HTM SOLO Results Support ReCor’s Renal Denervation System

Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the third of three Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including the final results of the MOMENTUM 3 trial of Abbott’s HeartMate 3 left-ventricular assist device and six-month results from the RADIANCE-HTN SOLO trial of ReCor’s Paradise renal denervation system, and more. Check out Part I and Part II of our ACC Results Recap.

Tracking Trials Clinical Trials Research & Development

Results Recap: EndoBarrier Improves Obesity And Diabetes Outcomes In UK Study; Procept’s Aquablation Proves Effective Again

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition covers new clinical data released March 8 to March 22, not including the data presented at the annual conferences of the American Academy of Orthopedic Surgeons or American College of Cardiology, which are presented in separate special editions of Results Recap.

Tracking Trials Clinical Trials

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

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

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
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