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Featured Stories


FDA Awash In Adverse Events: All-Time High Of 1.5 Million MDRs Reported In 2017

US FDA statistics shared with Medtech Insight show that the number of Medical Device Reports sent to the agency dramatically rose last year, both in individual and summary formats. Might the agency's upcoming Voluntary Malfunction Summary Reporting Program slow the overall number of MDRs this year?

FDA Safety Compliance

Bioelectronics, Imaging Fortify Medtech's Defense Against Rheumatoid Arthritis

As rheumatoid arthritis treatment improves in the biologics era, patients need fewer joint replacements. Instead, they now require more closely monitored, agile care, in the face of a growing shortage of qualified rheumatologists. These demands help propel digital health applications, bioelectronic devices and novel imaging modalities into the medtech spotlight.

Inflammation Neurology Commercial

One UK Notified Body To Be Phased Out This Year As It Moves To Sweden

Notified bodies are busy repositioning themselves this year in the light of Brexit. One UK notified body is relocating to Sweden, but it is playing down Brexit and emphasizing the benefits of centralization.

Brexit Europe Regulation

Global Approvals Analysis: LivaNova, Abbott, Medtronic, Boston Scientific Lead List Of January Cardio Approvals

January brought 23 non-US approvals, including 13 CE marks, according to Medtech Insight's Approvals Tracker. The total for January 2018 also exceeds the 20 non-US approvals recorded a year ago.

 

Approvals Innovation Cardiovascular

QUOTED. Feb. 21, 2018. Jack Wong.

Check out what Jack Wong, secretary of  the Asia Regulatory Professional Association,  had to say about the oncoming medical device regulations in the Philippines.
Quoted Asia Pacific Malaysia

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Policy & Regulation Explore this Topic

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'Program Alignment': 10 Things You Always Wanted To Know About FDA's New Inspection Scheme (But Were Afraid To Ask)

Now that US FDA's "program alignment" inspection paradigm is in full swing, does your device firm know where to send an FDA-483 response? How to alert the agency about a recall? Who to contact if there is a problem with an FDA investigator? If not, then check out the answers to those questions – and seven more – in this feature article.

Compliance FDA Quality Control

Labs File Suit Against US Government In Dx Pay-Rule Case

The American Clinical Laboratory Association last week requested summary judgment in federal court against the US Department of Health and Human Services over a Medicare final rule setting clinical diagnostic laboratory test reimbursement rates.

Legal Issues Market Access Reimbursement

QUOTED. Feb. 22, 2018. Dan Vukelich.

Check out what Association of Medical Device Reprocessors President Dan Vukelich had to say about his expectations in the European market now that new rules of the road are being established for reprocessing of single-use devices in the EU.

Quoted Europe

Premier 'Highly-Committed Purchasing Program' Would Choose Suppliers With Best Outcomes Data

Group-purchasing organization Premier recently launched the program, designed to award sole-source contracts to makers of advanced imaging equipment, infusion pumps, catheters, orthopedic implants, scalpels, and other medtech equipment and supplies that have shown that they have the best outcomes data and are high-level clinical performers.

Reimbursement Quality

New FDA Rule Aims To Give More Flexibility To Foreign Trials

In response to a five-year-old congressional mandate, the US agency has updated a rule and issued a companion guidance that would allow more flexibility for sponsors conducting studies outside the United States.

Clinical Trials Regulation

Warning Letter Roundup & Recap – Feb. 20, 2018

A maker of catheters, cannulae, tubing and aspirators ran afoul of US FDA's Quality System Regulation in the only device-related warning letter released by the agency this week.

Device Warning Letters FDA

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

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

Quality Control & Compliance Explore this Topic

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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 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

Commercial Explore this Topic

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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

Novacyt Confident Of Further APAC Growth

Clinical diagnostics firm Novacyt is confident of further growth in Asia-Pacific after sales in China exceeded the company's expectations.  

Asia Pacific Commercial

Roche To Improve Real-World Cancer Data Extraction With Flatiron Buy

Acquisition reflects that regulatory-grade real-world evidence will play increasing role in drug discovery, development, commercialization and reimbursement.

Commercial M & A

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

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

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: 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

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
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