Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories


Coronavirus: All FDA Inspections Of Chinese Manufacturing Facilities Come To Screeching Halt

The US agency has suspended all routine surveillance inspections in China through the end of March because of coronavirus fears, commissioner Stephen Hahn announced late on 14 February. Despite expecting medical product shortages, Hahn said the agency is being proactive: “We are not waiting for drug and device manufacturers to report shortages to us” before acting. The timing of Hahn’s statement – at 6 p.m. EST on a Friday, at the beginning of a three-day US holiday weekend – suggests he isn’t particularly excited to share the information.

FDA Enforcement Compliance

HHS Advances AI Priorities In Budget Ask

The US Department of Health and Human Services is asking Congress for $10m in its latest budget request specifically to advance the use of artificial intelligence to regulate FDA products and promote development of AI technology. The ask aligns with President Trump’s vision for government agencies to help make the US a leader in AI and machine learning products.

Regulation Policy Artificial Intelligence

11 Notified Bodies Under MDR Now As Ireland’s NSAI Is Officially Designated

With just over 100 days to go until the full application of the EU Medical Device Regulation, notified body designations are trickling through. Ireland is the latest to now have a resident EU MDR notified body.

Europe EU Regulation

US FDA Deems MiniMed Safety Issues Class I Recall

Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.

Recalls Safety Diabetic Care

Spotlight On Coronavirus

CDC Urges Diagnostics Makers To Scale Up Coronavirus Test

The second in command at the US Centers for Disease Control and Prevention said with the help of the Chinese government, the agency was quickly able to develop a diagnostic test for the new coronavirus – but now the private sector should use its resources to scale up production of the tests.

Commercial Policy

QUOTED. 14 February 2020. Anne Schuchat.

The US Centers for Disease Control and Prevention (CDC) developed a diagnostic test relatively quickly after news hit that a new coronavirus is spreading across China. Now top health officials say diagnostic manufacturers should help scale up the production of these tests. See what Anne Schuchat, principal deputy director of the CDC, said about it here. 

Quoted Policy Approvals
 
The EU Medical Device Regulation comes into force on 26 May. Click here to read more.

Latest from PR Newswire

Click here to access further medical device and diagnostics news.
 


Recent Tweets from Medtech Insight


Medtech IT: How To Stay Ahead As Technology Accelerates

Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found. Read this whitepaper to view more survey results and discusses how tech is changing Medtech.

Read the Whitepaper

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

UK Medicines And Medical Devices Bill Laid Before Parliament

UK health minister Baroness Blackwood will introduce the new UK Medicines and Medical Devices Bill before Parliament today, just before the House of Commons goes into recess. The government wants new legislation for devices and medicines in place before the end of the Brexit transition period.

United Kingdom Regulation Medical Device

FDA Finalizes Peripheral Vascular Atherectomy Guidance

The US agency made few changes in finalizing a 13 February guidance document on medical devices made to remove plaque from diseased arteries, but did incorporate manufacturer recommendations on corrosion testing and predicate comparisons.

Regulation Medical Device Cardiology

Experts: Chinese Tariff Cuts Good For Medtech, But Deliver Small Impact

Two top trade experts tell Medtech Insight that China’s recent decision to reduce tariffs is in response to the US government’s announcement that it, too, would reduce tariffs in an apparent bid to deescalate the seemingly never-ending trade war. Dropping tariffs will also help China meet its obligations under a so-called Phase 1 trade deal agreed to by the two countries.

Trade China

FDA’s Device Center Could Raid $2.8M From Staff Outreach, Training Kitty In 2021 To Fund Other CDRH Needs

While the Trump administration’s proposed fiscal year 2021 budget for the US FDA would give the agency’s device center a 5.3% increase for medtech product approvals and safety, the center’s lofty plans to become the world’s premier regulator of new AI-driven gadgets, next-gen diagnostics and other novel devices means it will have to tap about $2.8m dollars usually set aside for staff training and outreach to help meet its ambitious goals.

Regulation FDA

FDA Wants $18M To Update Outmoded Device Program IT Systems

The US agency says its medical device program is in desperate need of an information technology upgrade, noting that its outdated IT systems, tools and approaches could leave it flat-footed when dealing with cybersecurity threats and ever-evolving medtech. That’s why the FDA is asking Congress for $18m to tackle the IT sore spot.

FDA Policy

Warning Letter Roundup & Recap – 12 February 2020

No device-related warning letters were released by the US FDA the week of 12 February.

Device Warning Letters FDA

Premarket Innovators And SMEs (Part 2): Running Out Of Time In The EU MDR Race

In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some of the problems that medtech premarket innovators and SMEs are facing, with the EU MDR application date now less than four months away.

Regulation EU

CDC Urges Diagnostics Makers To Scale Up Coronavirus Test

The second in command at the US Centers for Disease Control and Prevention said with the help of the Chinese government, the agency was quickly able to develop a diagnostic test for the new coronavirus – but now the private sector should use its resources to scale up production of the tests.

Commercial Policy

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

FDA Blames ‘Super Office’ Reorg For Falling Short On 2019 Review-Time Goals For Recalls, High-Risk Adverse Events

The US agency says it missed critical goals for evaluating product recalls and so-called Code Blue Medical Device Reports (MDRs) in fiscal year 2019 – and it’s pinning the blame squarely on a massive reorganization of its device center. This isn’t the first time the FDA has pointed to the “super office” shakeup as a disruptor.

FDA Quality

Warning Letter Nosedive: FDA Makes History (Yet Again) By Sending Only 21 Of The Missives To Device Firms In 2019

A mere 21 quality-related warning letters were issued to device makers last year, the US agency tells Medtech Insight. It’s the third year in a row that the FDA has given out a record-low number of letters. In fact, 2019’s count of 21 represents a whopping 83% decrease from just five years ago, when 121 letters were sent to companies.

FDA Device Warning Letters

US Regulatory Roundup, January 2020: Recalled Surgical Gowns; Coronavirus News; FDA Inspection Tips; And More

News that device giant Cardinal Health recalled millions of potentially unsafe, unsterile surgical gowns – and a message out of the US FDA for customers to “immediately discontinue” using the gowns – was of most interest to our online readers last month. Meanwhile, the FDA’s plans to hasten emergency-use approvals of coronavirus test kits and a set of 10 tips for dealing with agency investigators also garnered significant attention. Here are January’s 10 most popular US policy and regulation stories from Medtech Insight.

Regulation Policy

Commercial Explore this Topic

Set Alert for Commercial

ResMed Jumps On Board As Nyxoah Raises €25m For Neurostim Apnea Device

The proceeds from the investment will enable Nyxoah to prepare for the IDE pivotal trial of the Genio system in the US, and accelerate market access and commercialization activities in Europe, Australia and New Zealand.

Financing Clinical Trials Commercial

Experts: Chinese Tariff Cuts Good For Medtech, But Deliver Small Impact

Two top trade experts tell Medtech Insight that China’s recent decision to reduce tariffs is in response to the US government’s announcement that it, too, would reduce tariffs in an apparent bid to deescalate the seemingly never-ending trade war. Dropping tariffs will also help China meet its obligations under a so-called Phase 1 trade deal agreed to by the two countries.

Trade China

Medtronic Adds UK-Based Digital Surgery To Support Robotic Surgery

Digital Surgery, a London-based developer of surgical artificial intelligence, analytics, digital education and training solutions, will join Medtronic’s surgical robotics business within its minimally invasive therapies group.

Artificial Intelligence Robotic Surgery

Device Week, 12 February 2020 – A Close-Up On AbioMed's Plan To Counter Unfavorable Impella Data

In this edition of Device Week, Medtech Insight's managing editor Marion Webb talks with deputy editor Reed Miller about his recent story on Abiomed's plan to counter unfavorable studies of its Impella heart pump.

[Editor's note: This article was updated on 14 February 2020 to clarify that Abiomed has invested more than $100m over the past five years in clinical research on the Impella heart pump platform. Abiomed has not committed to spend another $100m on new physician education and communication programs.]

Device Week Clinical Trials

Execs On The Move: Midmark Gets New Financial Chief; Toxys And CardioFocus Fill Positions In-House

Midmark, a dental and hospital equipment manufacturer, has a new CFO; CardioFocus promoted its president and COO to CEO; Toxys, an in vitro toxicity solutions firm, promoted top executives; and more.

Commercial Appointments

QUOTED. 12 February 2020. Tomer Lark.

Israel start-up Serenno Medical is planning a US launch for the Sentinel continuous urine output monitor for automatic monitoring and detection of acute kidney injury in patients treated in an intensive care unit. See what Serenno's CEO, Tomer Lark, said about it here.

Quoted Innovation

CDC Urges Diagnostics Makers To Scale Up Coronavirus Test

The second in command at the US Centers for Disease Control and Prevention said with the help of the Chinese government, the agency was quickly able to develop a diagnostic test for the new coronavirus – but now the private sector should use its resources to scale up production of the tests.

Commercial Policy

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Newly Cleared Cardiac Ultrasound Software Could Broaden Imaging User Base

The US FDA has cleared Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. In clinical trials, the system allowed untrained nurses to gather diagnostic-quality pictures and videos.

Diagnostic Imaging Approvals Research & Development

QUOTED. 13 February 2020. Charles Cadieu.

The US FDA cleared Caption Health's Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. See what Caption Health's co-founder and president, Charles Cadieu, said about it here. 

Quoted Approvals

Medtronic Hopes To Refine Renal Denervation Hypertension Therapy With New Trial

The 50-patient SPYRAL DYSTAL trial will evaluate the benefits of a new targeted renal denervation approach with the Symplicity Spyral renal denervation system in patients with uncontrolled hypertension.

Clinical Trials Innovation

Italian Medtech Industry Launches Investment Trends Study

The Italian medtech industry association Confindustria Dispositivi Medici has launched a major survey of the activities and investment strategies of the sector’s almost 4,000 domestic developers and manufacturers.

Italy Medical Device

Abbott Stays Ahead Of Edwards In Transcatheter Mitral Valve Race With Tendyne CE Mark

Tendyne is indicated for the treatment of significant mitral regurgitation in patients who are not candidates for surgery. It complements Abbott’s MitraClip mitral valve repair device and is an important part of the company’s strategy to be the leading structural heart device company.

Approvals Clinical Trials

Eko’s AI Algorithm To Detect Heart Conditions Cleared By US FDA

US regulators have cleared a suite of cloud-based artificial intelligence software intended to be used with Eko’s digital stethoscopes to detect certain heart problems. The company says the AI algorithms are the first of its kind to be cleared by the US FDA.

Approvals Artificial Intelligence

Study Links Paclitaxel To Lower-Leg Amputations

New research links the use of stents and balloons coated with the drug paclitaxel to an increased risk of lower-leg amputation shortly following surgery. The study was conducted by Greek researcher Konstantinos Katsanos, who previously found an increased mortality risk in paclitaxel-treated patients.

Research & Development Medical Device
UsernamePublicRestriction

Register