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Could New EU Regulatory Hurdles Put Up Barriers For Would-Be Reprocessors?

The EU's new Medical Device Regulation potentially allows commercially remanufactured devices to compete with in-house (in-hospital) reprocessed devices. Here, one expert explains why in-house reprocessing may not work.

Europe Regulation Medical Device

Start-Up Spotlight: Kephalios, Simplifying Targeted Mitral Valve Repair

Investors are betting on mitral valves as the next "big thing" in cardiology as interest in technologies to treat mitral regurgitation heat up among the big heart players. Competition among the developers of transcatheter mitral valve repair systems is intensifying as they jostle for attention, but start-up Kephalios believes the simplicity of its technology, which precisely targets repair of the defective valve, will help it stand out.

Innovation StartUps and SMEs Research & Development

HHS Chief Scores With Congress On DME Bid Program, Telehealth Pay, But Says LDTs Complex

At back-to-back congressional hearings on Feb. 14 and 15, US Health and Human Services Secretary Alex Azar seemed to satisfy lawmakers' questions on how he would use his budget to fix problems in the durable medical equipment bidding program and provide telehealth reimbursements under Medicare, but conceded that lab-developed test regulations are a complicated issue.

Legislation Policy Regulation

Asia Reg Roundup: Philippines Sets Short Reg System Deadline, Vietnam Defers, Malaysia Extends

New regulatory systems for devices are proliferating in the ASEAN and South-East Asia region. Some have set short compliance deadlines that have turned out to be unworkable. Will the Philippines, which in January issued an Administrative Order establishing a new risk-based regulatory system, suffer the same fate? Medtech Insight discussed the issue with local regulatory experts Jack Wong and May Ng.

Asia Pacific Malaysia Philippines

Compliance 360° Part 13: Navigating The Quicksand Of Device/Drug Combo Products (2 of 2)

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 13th installment – the second of two parts – former FDA investigations branch director Ricki Chase brings you the latest insights into the complexity surrounding combination device/drug products. In this podcast, Chase digs deep into design control, design changes, human factors studies and biocompatibility concerns for combo products. She also discusses some pre- and post-market considerations, as well as common pitfalls to avoid.
Compliance 360 Combination Products Compliance

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Notified Bodies Apply For Same Or Bigger Scope Under MDR, Says EU Group

Industry is desperate for more information about notified body applications under the new EU Medical Device and IVD Regulations. Will insights just released by TEAM-NB be enough to satisfy companies' need to know?

Europe Brexit Policy

Warning Letter Roundup & Recap – Feb. 13, 2018

In the only device-related warning letter released by US FDA this week, dental device-maker Curasan was cited for quality systems and Medical Device Reporting troubles.

Device Warning Letters FDA Quality

Saudi FDA Finalizes Guidance On Closing Device Field Safety Notices

Final Saudi FDA guidance on how to close field safety notices explains which documents device manufacturers should submit, and by when.
Safety Saudi Arabia

QUOTED. Feb. 16, 2018. Scott Gottlieb.

US FDA Commissioner Scott Gottlieb is looking for more money for the agency's device center so it can help support the National Evaluation System for health Technology (NEST). Check out what he said here.

Quoted Digital Health

First Concussion Blood Test Leverages De Novo, Breakthrough Pathways

The Banyan Brain Trauma Indicator is the first blood test for detecting concussions in adults to reach the US market and the second device to emerge from US FDA's Breakthrough Devices Program. While test-maker Banyan Biomarkers originally flirted with the PMA pathway, FDA swayed it to the de novo process, which the firm ultimately leveraged to gain the market go-ahead.
Approvals In Vitro Diagnostics

Digital Health, Cybersecurity Would See Significant Chunk Of FDA Device-Funding Boost

If Congress approves a 26% higher 2019 funding request for US FDA's device center, a substantial chunk of those dollars would go to building a novel framework for regulating digital-health technologies, and to help FDA and device manufacturers respond better to cybersecurity vulnerabilities, among other program priorities, according to agency officials.

Legislation Digital Health

Saudi FDA Wants Device & Drug Firms To Report Payments To Doctors, Health Institutions

The Saudi Food and Drug Authority has finalized the details of a new transparency initiative under which medical device and pharmaceutical companies will have to disclose their financial relationships with health-care professionals and institutions. 
Advertising, Marketing & Sales Policy & Regulation

Top EU Court Sends Clear Message On Software: Will France Back Down?

French medtech industry representatives who want local software certification requirements annulled are shaking up the software and applications industry on the medical borderline.

Digital Health Policy

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Compliance 360° Part 12: Navigating The Quicksand Of Device/Drug Combo Products (1 of 2)

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 12th installment – the first of two parts – former FDA investigations branch director Ricki Chase offers the latest insights into the complexity surrounding combination device/drug products. In this first podcast, Chase reviews regulations and guidance documents related to combo products, and highlights the varying types of combo products, definitions unique to device design, and how combo product manufacturers differ from the typical medical device or drug firm.

Compliance 360 Combination Products

Q4 Recalls Snapshot: Recalled Devices At 6-Year Low; Software Issues Remain Top Recall Reason

There were 152 recalls in the fourth quarter of 2017, a 9% decline from Q3, when 167 corrections & removals were initiated by device-makers. The Q4 figure also represents the lowest number of recall events in a quarter since Q4 2011. Check out our Q4 recalls infographic.

Recalls Quality

Stacking Bricks: FDA Unveils Structure For New Office Of Product Evaluation And Quality, Touts Benefits Of OPEQ

US FDA's Sean Boyd gave an inside look at how the agency plans to organize its Office of Product Evaluation and Quality (OPEQ) – the so-called "super office" that will consolidate a handful of current, distinct offices that handle pre-market, compliance, enforcement and post-market surveillance activities. Plus: Five expected benefits for device-makers (and five for FDA) under the OPEQ reorganization are highlighted.

Policy FDA

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Synergia Lights Up With $10m For Smaller, MRI-Friendly, Rechargeable Neurostim Device

Belgian Synergia Medical has scored €8.1m ($10.1m) in Series A funding to take the company's vagus nerve stimulation device through to advanced-stage testing before filing for CE marking. 

Neurology Commercial Deals

Medtech Money Flow: Weekly M&A And VC Deals, Feb. 12-18, 2018

In this weekly feature, Medtech Insight presents a roundup of the previous week's M&A deals and venture financing rounds recorded in our M&A and VC Deal Trackers. This edition presents the transactions announced between Feb. 12-18, 2018.
Financing M & A

LivaNova To Buy TandemLife For Up to $250m, Adding Complementary Cardiac Surgery

London-based cardiac surgery and neuroscience group LivaNova PLC is buying privately held Pittsburgh-based TandemLife in a deal worth up to $250m. TandemLife develops advanced cardiopulmonary temporary support systems that are complementary to LivaNova's cardiac surgery segments.
Deals Cardiology

Insulet To Pay $19.5m Settlement In Investor Fraud Case

Insulet has agreed to pay $19.5m to settle claims it misled investors about the safety and success of its Eros insulin infusion pump at launch.
Medical Device Legal Issues

India's Device Price Cap Storm Rages On: New Stent Cap And Spotlight On Catheter Trade Margins

India’s medical device pricing storm looks unlikely to abate any time soon, with another round of price caps on stents being enforced. The spotlight is also shining on the sharp variances in trade margins for catheters in the country.
India Pricing Debate

M&A Analysis: January, Crisp Start To The Year

2018 kicked off with 17 medtech M&A deals in January, an increase from the 12 transactions recorded in the same period last year. The month also saw major medtech players reel in some significant acquisitions.

Commercial Companies

Successful Selling: Making Cents Of Europe's Fragmented Medtech Market

While the sheer size of the US market might present a challenge to European medtech companies, at least it is homogenous. Europe's notoriously fragmented nature, on the other hand, requires a different sales approach, from country to country. In this article, the third in a four-part series focused on sales strategies, Brian Chapman and Lukas Grabner of global sales and marketing strategy consulting firm ZS outline the most important things to take into consideration when tackling the different European medtech markets.

Europe Market Access

Clinical R&D Explore this Topic

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FDA Lowers Barrier To Market Penetration For Abiomed's Impella With Expanded Indication

FDA has removed "depressed ejection fraction" from the approved indication for Abiomed's Impella 2.5 and Impella CP based on results from the cVAD registry. The registry data support expanding the FDA-approved indication for the heart pumps during elective and urgent high-risk percutaneous coronary interventions, as well as for patients with cardiomyopathy leading to cardiogenic shock.
Approvals Clinical Trials Innovation

QUOTED. Feb. 19. 2018. Dan Bournstein.

Check out what Saluda Medical President Dan Bournstein had to say about the firm's responsive, closed-loop spinal cord stimulation technology for which it is seeking CE mark this year and FDA approval by 2020.

Quoted Start-up Spotlight

Start-Up Spotlight: Saluda Hopes To 'Evoke' From Down Under With First Closed-Loop Spine-Stim System

Aiming to improve the lives of patients living with chronic, intractable pain, Australian start-up Saluda Medical Pty Limited is the first and only neuromodulation company in the world to develop a closed-loop spinal cord stimulation system (SCS). Unlike other SCS systems marketed today, Saluda’s device, currently in clinical trials, is designed to measure the spinal cord’s response to electrical stimulation, and then respond to patient's preferred stimulation. 

Neurology Start-up Spotlight

Stroke Decision-Support Software Gets US Approval

While US FDA works on a new guidance for clinical decision support software, the agency has OK'd the de novo application for Viz.AI Contact, a software tool to help detect early signs of strokes.
Approvals Digital Health

Novel Medical-Imaging Isotope Platform Nabs US FDA Approval

The RadioGenix System from NorthStar Medical Radioisotopes will be the first system to make the most common radioactive isotope used in imaging in the US in 30 years, using an innovative process that avoids the need for enriched uranium.

Medical Device BioPharmaceutical

LINC 2018: More Data Demo IN.PACT's Impact, And Other Vasc-Device Findings

The 2018 Leipzig Interventional Course (LINC), Jan. 30-Feb. 2, featured presentations of data from trials of peripheral stents from Biotronik and Veryan, TVA Medical's arteriovenous fistula, and drug-coated balloons from Medtronic, Boston Scientific, and Spectranetics.

Cardiovascular Clinical Trials

Oxford Biodynamics, Holos Partner Up On Concussion

Oxford Biodynamics and Holos Life Sciences are putting their heads together to develop noninvasive epigenetic biomarkers for sports-related concussions. The analysis aims to identify biomarkers that potentially could be monitored and improve athlete rehabilitation.

Research & Development Commercial
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