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FDA Warns Eye Care Company Conducting Unapproved Clinical Trial Of Drug-Device Product

The FDA sent a warning letter to Arbor Center for EyeCare for failing to submit an IND before beginning a trial of a novel drug-device combination product.

Warning Letters Regulation FDA

Canon To Launch US-Based Medical Imaging Company In January 2023

Japan-based Canon plans to launch a US-based medical imaging company near Cleveland to strengthen its US presence and competitiveness in the marketplace.

Business Strategies Growth Launches

European Regulatory Roundup, November 2022: EU MDR Situation Now Critical

Damage limitation action is expected imminently to try and stem the flow of medtech products being taken off the EU market. And it cannot come quickly enough as evidence continues to mount of the negative fall-out resulting from the way the EU’s new medical device regulations have been, and are being, implemented.

EU Europe Medical Device

Medtronic Issues Another Recall For The HeartWare VAD System

The latest recall for Medtronic's HeartWare Ventricular Assist Device (HVAD) System was triggered by reports of hardened driveline boot covers, which can make disconnecting the driveline from the controller difficult.

FDA Regulation Recalls

Boston Scientific Makes Half Billion Dollar GI Endosurgery Play

Boston Scientific is greatly increasing its GI endosurgery capabilities with the acquisition of Apollo Endosurgery, a manufacturer of various device for weight loss-related surgeries.

Commercial Companies Deals

CMR Signs Deal With J&J To Bring Robots To Europe And South America

CMR Surgical will collaborate with Johnson & Johnson/Ethicon to expand access to its Versius robotic surgery system.

Minute Insights Robotic Surgery Deals

More Than 50% Of EU Clinicians Report Recent Medical Device Shortages

Shortages of medical devices ranging from insulin pumps to robotic surgical systems are impacting clinicians across the EU, leaving many healthcare providers without effective alternative products, a report by the Biomedical Alliance in Europe shows.

Europe EU Medical Device

Medtech Monthly Podcast

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Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics. >More Podcasts

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Policy & Regulation Explore this Topic

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It’s A Class I Recall For Baxter’s WatchCare Device

Radiofrequencies from the incontinence-sensing devices may interfere with other medical equipment in a hospital setting. 

Recalls Regulation FDA

CAMD Says ‘Critical Appraisal’ Needed On EU MDR Capacity Bottlenecks

Yet another EU regulatory organization has stressed the need for action to address MDR capacity problems. According to CAMD, underlying factors and causes of the crisis must be identified.

EU Europe Medical Device

Latest From Policy & Regulation

Some Essential Cardiac Devices In Short Supply, FDA Warns

The US Food and Drug Administration is alerting health care providers that some cardiac devices from a major supplier are in short supply.

FDA Policy

Crucial Council Of EU Debate On Medical Device Regulation Crisis Countdown

The Council of EU’s agenda for the critical upcoming health council meeting confirms position of EU Medical Device Regulation in day’s running, along with other key health issues.

EU Europe

Reclassification Of Active Annex XVI Products Now Official

Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.

EU Europe

AI Experts Tell UK MHRA How To Regulate AI Proportionately So Patients Benefit

UK policymakers will need to walk a fine line when developing regulation for AI as a medical device. An independent expert review sets out the need for carefully balanced rules that support innovation without allowing unsafe products to enter the market.

Europe EU

Temporary Stent To Treat Prostate Enlargement Gets FDA Greenlight

The US FDA has approved a temporary prostatic stent from SRS Medical Systems that allows urine to flow through the urethra when it is blocked by an enlarged prostate.

FDA Regulation

On-Prescription Apps Are Just One Vital Part Of Germany’s Digital Strategy

Are too few digital health care apps approved for reimbursement in Germany? That’s not the point, says the health care ministry, urging a look at the bigger strategic picture.

Germany Digital Health

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Crucial Council Of EU Debate On Medical Device Regulation Crisis Countdown

The Council of EU’s agenda for the critical upcoming health council meeting confirms position of EU Medical Device Regulation in day’s running, along with other key health issues.

EU Europe

Reclassification Of Active Annex XVI Products Now Official

Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.

EU Europe

EU Designates First Czech Notified Body Under MDR

The latest notified body listing brings total number of EU designated Medical Device Regulation testing and certification organizations to 35.

Europe EU

Commercial Explore this Topic

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Digital Health Roundup: HLTH2022 Highlights, EU Updates, Diabetes Medtech Monthly

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent HLTH conference in Las Vegas. Reed Miller and Barnaby Pickering offer an overview of the highly competitive diabetes tech market. We also talk about digital health in Germany and Europe.

Digital Health Innovation Artificial Intelligence

Latest From Commercial

Some Essential Cardiac Devices In Short Supply, FDA Warns

The US Food and Drug Administration is alerting health care providers that some cardiac devices from a major supplier are in short supply.

FDA Policy

GE Finalizes Details Of GE HealthCare Spin-Off

Over four years in the making, the deal will spin-off General Electric’s health care business into a separate public company.

Medical Device Commercial

Minute Insight: GE Healthcare Partners With MediView XR To Create AR Solution For Integrated MR Imaging

GE Healthcare and MediView announced a partnership to co-develop a technology platform that integrates medical imaging into mixed reality solutions.

Minute Insights Digital Health

Temporary Stent To Treat Prostate Enlargement Gets FDA Greenlight

The US FDA has approved a temporary prostatic stent from SRS Medical Systems that allows urine to flow through the urethra when it is blocked by an enlarged prostate.

FDA Regulation

Cordis Looks To Regain Previous Innovation Edge With Drug-Eluting Balloons

Medtech Insight followed-up with Cordis CEO Shar Matin to talk about the company’s path forward as an innovative intervention company following the acquisition of MedAlliance.

Exec Chats Clinical Trials

Tandem’s CSO Speaks On Insulin Pump Development And Its Challenges

Insulin pumps have lagged behind continuous glucose monitors in terms of market penetration due to their cost and the complex regulatory framework that surrounds them. Elizabeth Gasser, chief strategy officer at Tandem Diabetes spoke to Medtech Insight about these challenges and how the company is taking a slightly different approach to pumps.

Strategy Platform Technologies

Clinical R&D Explore this Topic

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So, You Built A Surgical Robot. How Do You Sell It?

CMR Surgical has grown rapidly since being founded just over eight years ago. However, unlike most other medtech companies, CMR is not selling a ~$30 diagnostic test, or a ~$5,000 pacemaker. It is selling a complex surgical robot, called Versius, with a price tag rumored to be in the seven figures. 

Robotic Surgery Growth Platform Technologies

Latest From Research & Development

Minute Insight: GE Healthcare Partners With MediView XR To Create AR Solution For Integrated MR Imaging

GE Healthcare and MediView announced a partnership to co-develop a technology platform that integrates medical imaging into mixed reality solutions.

Minute Insights Digital Health

Minute Insight: Apple Watch Now Features FDA-Cleared App To Monitor Parkinson’s Disease Symptoms

A newly cleared Apple Watch app will allow people living with Parkinson’s to more easily track tremors, dyskinesia and other symptoms.

Digital Health Neurology

HLTH 2022 Roundup: Mirvie, Grail, Biofourmis, Komodo Health, Babson Diagnostics

This year’s annual HLTH meeting drew more than 9,000 people to Las Vegas from 13-16 November and hundreds of exhibitors. In this first part of a two-part roundup, Medtech Insight highlights interviews with C-suite executives at Mirvie, Grail, Biofourmis, Komodo Health and Babson Diagnostics.

Innovation Digital Health

Minute Insight: Apple Watch Helps Knee-Replacement Patients In Zimmer Biomet-Sponsored Trial

One-year data from a randomized controlled trial showed Zimmer Biomet’s mymobility app paired with the Apple Watch can effectively guide rehabilitation following knee-replacement surgery.

Minute Insights Digital Health

Is Osler Diagnostics The Next Theranos Or Can It Surprise Everyone?

Founded with a vision to change point-of-care diagnostics, Osler Diagnostics has raised nearly $200m to develop and commercialize a platform that promises to revolutionize diagnostics with just a drop of a patients’ blood.

In Vitro Diagnostics Platform Technologies

HLTH 2022: NuraLogix Demo AI Models That Can Predict Risk For Pre-Diabetes

NuraLogix developed machine-learning models that use facial blood flow patterns to predict disease. The company plans to pursue US FDA de novo authorization for its blood pressure monitoring module first in 2023. 

Artificial Intelligence Digital Health
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