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Sterilization Facility Shutdowns Could Spell Medical Device Shortage; FDA Urges Firms To Assess 'Downstream Impacts'

US FDA says the closing of at least two sterilization facilities due to environmental hazard concerns could lead to a device shortage. The agency is working with stakeholders to come up with mitigating strategies, including finding new sterilization methods and facilities. The issue has prompted FDA to plan a public hearing later in the year to strategize on solutions and an innovation challenge to come up with new sterilization methods. In the meantime, to help industry understand its latest thinking on ethylene oxide for sterilization use, FDA has launched a website to provide resources and updates, including the latest sterilization facility closures.

United States Advisory Committees Distribution

Zimmer Biomet's ROSA One Spine System Wins FDA Nod; Other Solutions Presented At AAOS 2019

US FDA cleared Zimmer Biomet's ROSA ONE spine application last Friday. During the recent Academy of Orthopedics Surgeons conference, Medtech Insight talked to Zimmer Biomet's general manager of Global Spine, Rebecca Whitney and Michelle Bianco, VP of Operations, to learn about the company's product pipeline and future strategy. 

Commercial Clinical Trials Companies

New MITA Standard Helps Servicers Of Imaging Devices Develop Quality Systems, Avoid Remanufacturing

The Medical Imaging & Technology Alliance has released a voluntary standard that guides servicers of medical imaging equipment on how to best set up a quality system. NEMA/MITA 2 also aims to keep servicers from crossing the line into remanufacturing – an FDA-regulated activity.

Standards Diagnostic Imaging Quality Control

Novocure Launches INNOVATE 3 Trial Of Ovarian Cancer Therapy

INNOVATE 3 is a phase 3 pivotal trial testing the efficacy of Novocure's Tumor Treating Fields therapy combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer.

Starts & Stops Tracking Trials Research & Development

Execs On The Move: New HR Faces at LivaNova & Cantel; New Finance Hires at Mallinckrodt & Check-Cap

Neuromodulation and cardiovascular device firm LivaNova welcomes a chief human resources officer, and a former Merck exec takes the same title at infection prevention company Cantel Medical; specialty/generic drug and imaging firm Mallinckrodt and medical diagnostics business Check-Cap both add chief finance officers; and more.

Appointments Commercial Medical Device

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Policy & Regulation Explore this Topic

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EU Favors Italian Medtech Nomenclature Over GMDN For Revamped Eudamed

European authorities have opted for Italy's medical device classification codes (CMD) instead of the Global Medical Device Nomenclature in the revamped medtech database Eudamed to ensure that manufacturers have free access to an internationally recognized nomenclature.

Europe Regulation Safety

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

Warning Letter Roundup & Recap – March 26, 2019

No device-related warning letters were released by US FDA the week of March 26.

Device Warning Letters FDA

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

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

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

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

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

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CardioFocus' HeartLight X3 Endoscopic AFib Ablator Earns CE Mark

HeartLight X3 is the third-generation version of the HeartLight endoscopic laser ablation system for pulmonary vein isolation to treat atrial fibrillation.

Approvals Research & Development Commercial

Guerbet Targets Multi-Use Markets To Grow Interventional Imaging Biz

French imaging agent specialist Guerbet is targeting multi-use markets to grow its interventional imaging business while continuing to build through acquisitions. While its diagnostic imaging revenues were about flat in 2018, its imaging intervention business grew almost 19% in constant currency compared to 2017.

Diagnostic Imaging Commercial

Global Device Approvals Snapshot For March 18 - March 25, 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week FDA approved Impulse Dynamics’ Optimizer Smart impulse generator for cardiac contractility modulation therapy, CardioFocus’ HeartLight Endoscopic Ablation system earned a CE Mark, and Health Canada approved a new version of DarioHealth’s smart-phone compatible continuous glucose monitor.

Approvals Research & Development

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

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: 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

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

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

FDA Approves Impulse Dynamics’ Optimizer Smart For Heart Failure As Breakthrough Device

The Optimizer Smart implantable pulse generator delivers Cardiac Contractility Modulation therapy to improve the quality of life and functional status of patients with advanced heart failure who are not indicated for cardiac resynchronization therapy. The agency granted Optimizer Smart as a Breakthrough Device because of its potential to improve outcomes for heart failure patients without other options.

Approvals Commercial Research & Development

Global Device Approvals Snapshot For March 18 - March 25, 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week FDA approved Impulse Dynamics’ Optimizer Smart impulse generator for cardiac contractility modulation therapy, CardioFocus’ HeartLight Endoscopic Ablation system earned a CE Mark, and Health Canada approved a new version of DarioHealth’s smart-phone compatible continuous glucose monitor.

Approvals 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

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

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
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