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Making Sense Of The Muddle Of EU Device Registration Timelines

The recent document from the European Commission's Medical Devices Coordination Group concerning device registration timelines is difficult to follow, with its many unexplained references. This article aims to clarify how the MDCG's findings affect the way manufacturers should prepare for MDR compliance.

EU Regulation Medical Device

Start-Up Spotlight: GT Medical Technologies' GammaTile Brings Brachytherapy Directly To Brain Tumors

Arizona-based GT Medical Technologies is ramping up commercialization of its GammaTile surgically targeted radiation therapy for patients with recurrent intracranial neoplasms. GammaTile already received 510(k) clearance, but continues to develop clinical evidence showing that GammaTile improves control of brain cancer following excision surgery and prolongs patient-survival.

Start-up Spotlight StartUps and SMEs Cancer

J&J Cleared In Philly Pelvic Mesh Trial

Product liability cases alleging manufacturers of pelvic mesh are responsible for patient injuries continued even as the US FDA is halting sales of the product. In the most recent verdict, a Philadelphia jury said Johnson & Johnson was not responsible for adverse events experienced by a Pennsylvania woman.

Legal Issues Safety Gynecology & Urology

Pivotal Trial Of Carmat’s Total Artificial Heart Delayed

Carmat suspended the production of its Total Artificial Heart while it strengthens certain manufacturing processes.

Research & Development Clinical Trials Innovation

Execs On The Move: Promotions At Midmark And Episurf Medical; Akili Welcomes Finance Leader

Medical products firm Midmark Corp. names a new VP of Corporate Accounts; ortho implant-maker Episurf Medical designates a COO; digital-medicine developer Akili Interactive Labs hires a new CFO; and more.

Appointments Commercial Medical Device

QUOTED. April 18, 2019. Cameron Piron.

At this year's annual American Association of Neurological Surgeons (AANS) conference, medical device makers demoed high-tech digital solutions for neurosurgeons. See what Synaptive Medical's president, Cameron Piron, said about its surgical planning software.

Quoted Neurology Innovation

Latest from PR Newswire

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Recent Tweets from Medtech Insight


Policy & Regulation Explore this Topic

Set Alert for Policy

WHO Consults On Remaining Shelf-Life Policy For Medical Products

The World Health Organization has framed a policy to help suppliers, donors, procurers and distributors manage medical products throughout the supply chain and ensure availability within their remaining shelf-life.

International Regulation Quality Control

'Full-Speed Ahead,' Says Acting US FDA Chief Sharpless

In his first speech to agency staff, US FDA acting Commissioner Ned Sharpless says the agency will continue working on issues such as the Medical Device Safety Action Plan, the precertification program and the National Evaluation System for health Technology (NEST). He also says he's not approaching the post like a temporary caretaker.

FDA Leadership Appointments

Device Week, April 17, 2019 – Safety Under Spotlight After Mesh Pulled From US Market, Pediatric Air Tubes Run Short

In this week's Medtech Insight podcast, Shawn M. Schmitt explains why the FDA ordered transvaginal mesh products removed from the US market, and Ferdous Al-Faruque highlights a growing device-shortage issue linked to problems at two US sterilization facilities.

Device Week FDA

Commission Told New EU Regulation ‘Clearly Untenable’ And ‘Not Ready To Function’

With just over 13 months until the EU Medical Devices Regulation is fully applicable, EU medtech manufacturers are imploring the European Commission to speed readiness of the new regulatory system or patients and industry will suffer.

EU Regulation

Warning Letter Roundup & Recap – April 16, 2019

No device-related warning letters were released by the US FDA the week of April 16.

Device Warning Letters FDA

FDA May Take Additional Regulatory Actions On Duodenoscopes, Shuren Says

The US FDA continues to find unacceptable levels of “high concern” disease-causing bacteria on duodenoscopes that have gone through cleaning and reprocessing steps, and is poised to take further action with three duodenoscope manufacturing firms to reduce patient risks.

Regulation Safety

FDA Yanks Transvaginal Mesh From US Market; Boston Sci 'Surprised'; Firms Have 10 Days To Submit Withdraw Plan

Transvaginal mesh products made by Boston Scientific and Coloplast were ordered pulled from US shelves by the agency on Aug. 16. Under the rare FDA order, the two firms must immediately stop selling the mesh and have 10 days to submit plans to the agency outlining how they will recall their unimplanted devices.

Recalls FDA

Legacy Devices In Eudamed Database: MDCG Proposes Regulatory Solution

The new EU medical device regulations  ̶  the MDR and IVDR – left a gap in how manufacturers of legacy products should comply with critical reporting requirements. A solution has been found.

EU Regulation

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

QUOTED. April 15, 2019. Luann Pendy.

Medtronic quality VP Luann Pendy worked with the US FDA and the Medical Device Innovation Consortium through its joint Case for Quality devise a so-called "#makeCAPAcool" initiative to recast corrective and preventive action as a continuous learning tool. See what Pendy said about the "monster called CAPA" here.

Quoted Quality

How A Team Led By Medtronic Quality Experts Plans To Stand Up To 'A Monster Called CAPA' – And Make It 'Cool'

The so-called "#makeCAPAcool" group wants to recast corrective and preventive action as a continuous learning tool, rather than a place where problems often go to linger, be ignored and never die. A new voluntary CAPA framework developed by the team and piloted by a handful of device-makers will be rolled out later this year.

Quality Control Manufacturing

With Fresh Guidance, US FDA Aims For Consistency In Device Facility Inspections

A new draft guidance document from the agency says domestic inspections should occur over a brisk three to six consecutive days, alleviating a pain point for device firms that say some agency investigators traipse in and out of an audit, sometimes causing inspections to drag on for weeks.

FDA Guidance Documents

Commercial Explore this Topic

Set Alert for Commercial

Market Intel: #AANS2019: High-Tech Microscope Technologies Illuminate Brains, Spines

This year's annual American Association of Neurological Surgeons conference offered neurosurgeons and allied health professionals five days of clinical trial news, seminars and live-streaming videos to learn about the latest developments in their field. Medtech Insight had an ear close to the ground, posting Tweets on some of the latest technologies, including robotic-assisted microscopes, showcased by exhibiting companies. Here is a round-up of the best of the Tweets and updates from company executives.

Neurology Innovation Market Intelligence

AngioDynamics Off-Loads Namic Fluid-Management Business To Medline

Medline Industries will pay $167.5m for the Namic brand of manifolds, contrast management systems, closed fluid systems, guidewires, disposable transducers and interventional accessories. It also includes a manufacturing facility and the manufacturing, sales and marketing staff that support Namic.

Deals M & A

QuantumMDx And Glaxo Smith Kline Partner On QC Analyzer For Cell And Gene Therapies

QuantumMDx Group Ltd has signed a deal with GlaxoSmithKline to co-develop a quality control analytics system for cell and gene therapies.

Commercial Companies

Two Dozen Charged In $1.2Bn DME Telemarketing Fraud

Two dozen telemedicine executives, durable medical equipment vendors and health-care providers have been indicted as part of what the US Department of Justice calls “one of the largest health-care fraud schemes” in recent years.

United States Commercial

QUOTED. April 17, 2019. Gioia Althoff.

SOPHiA GENETICS received the CE-IVD mark for its molecular diagnostic device, Solid Tumor Solution (STS). See what the company's genomics senior VP, Gioia Althoff, said about it here.

Quoted Cancer

SOPHiA GENETICS Secures CE Mark For Solid Tumor Solution Product

SOPHiA GENETICS has scored a CE-IVD mark for its molecular diagnostic device, Solid Tumor Solution (STS). 

Cancer Commercial

US FTC Approves Fresenius And NxStage Merger

The US Federal Trade Commission has finally approved Fresenius' $2bn acquisition of NxStage Medical. A complaint filed by the FTC in February 2019 claimed the deal would be anti-competitive.

M & A Deals

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

FDA Approves Qiagen’s Therascreen Urothelial Cancer Companion Diagnostic

The Therascreen FGFR kit helps identify urothelial tumors with alterations to the fibroblast growth factor receptor 3 gene that indicate the cancer will respond to Janssen’s new drug Balversa.

Research & Development Approvals Clinical Trials

Gelesis's Plenity Obesity Product Earns De Novo For Wide BMI Range

PureTech's affiliate Gelesis has received US FDA de novo clearance for its Plenity capsule to treat overweight-obese adults, and plans to launch it commercially in the second half.

Approvals Research & Development

Global Device Approvals Snapshot: April 9-15, 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Qiagen's therascreen FGFR RGQ RT-PCR companion diagnostic for Janssen's new drug to treat specific types of urothelial cancer and Intact Vascular's Tack device to treat dissections of the above-the-knee peripheral arteries following angioplasty.

Research & Development Approvals

Intact Vascular’s Tack Peripheral Dissection Repair Device Earns PMA

The approval of the Intact's peripheral artery dissection repair device is based on results from the 213-patient TOBA II trial, which showed Tack resolved 92.1% of dissections in peripheral arteries following balloon angioplasty.

Research & Development Clinical Trials

Avita’s Recell Heals 98% Of Burns In Pediatric Trial

The Recell system of Spray-On Skin Cells combined with mesh autografts healed 98% of burns within four weeks in 23 pediatric patients treated under US FDA-approved compassionate use and continued access programs.

Research & Development Clinical Trials

SPR's Peripheral Nerve Stimulator Relieves Post-Amputation Pain

SPR Therapeutics' Sprint percutaneous peripheral nerve stimulator proved safe and effective at reducing pain in post-amputation patients in a new 28-patient randomized study.

Research & Development Clinical Trials

Edwards’ Pascal Improves Mitral Regurgitation In Early Trial Results

One-month results from the CLASP trial, presented at the German Cardiology Meeting (DGK), show Edwards’ Pascal mitral valve repair device reduces mitral regurgitation in heart failure patients with moderate to severe mitral regurgitation.

Research & Development Clinical Trials