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Featured Stories


'Alice' In Patent Land: Finding Patentable Digital Health Innovations Is No Easy Task

While the mobile health sector and digital health in general is poised for a major boom, a 2014 case, Alice Corp. v. CLS Bank International, continues to be a major hurdle for manufacturers wanting to patent their software. While there are some recent positive trends, attorneys recommend caution and proactive steps to make the best of the current patent environment.

Digital Health Legal Issues Legislation

How Notified Body Notifications Could Handicap Parts Of The Medtech Industry

EU industry association MedTech Europe explains how the first-come, first-served approach to notified body notification threatens to disadvantage some in industry.

Regulation Europe Policy

Eurasian Union Medtech Harmonization Likely To Be Delayed, Says Russian Industry Group

The January 2022 entry-into-force date of a Eurasian Economic Union-wide regulatory system dominates thinking in Russia and the other EAEU member states. But differential progress has meant that a deadline extension is now working its way onto the agenda, observes Sergey Vanin, head of IMEDA, the Russian industry association.

EAEU Regulation Medical Device

Medicare Drops Registry Requirement In ICD Coverage Policy And Adds 'Shared Decision-Making'

The new Medicare coverage policy for implantable cardioverter defibrillators, the first revision since 2005, incorporates MRI-compatible devices, tweaks some of the patient criteria, removes thenational registry requirement, and adds a new requirement for "shared decision-making" prior to implanting an ICD in certain patients so the patients understand their options.

Market Access Medicare Reimbursement

QUOTED. Feb. 23, 2018. Anthony Arnold.

Anthony Arnold, CEO of device-maker SetPoint, says the drug industry is underestimating what patients really want when it comes to treating rheumatoid arthritis (RA). Check out what he said here.
Quoted Commercial Market Intelligence

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Policy & Regulation Explore this Topic

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Device Week, Feb. 23, 2018 – Down The Patent Hole With 'Alice'

Following a major Supreme Court patent case in 2014 that set a test for what is and is not patentable subject matter, medical device companies are struggling to protect their software, which is often considered not patentable. In this week's Medtech Insight podcast, we discuss the legal hurdles and what companies can do to push back.

Digital Health Device Week Legal Issues

Blockchain: The Answer to Medtech Traceability?

Pressures to control supply chains are increasing while governments are adding new requirements for companies to better track individual products. Blockchain technology is most often associated with cryptocurrencies like Bitcoin, but it has a lot to offer to the medtech space as a tool to enhance product traceability and address new EU regulatory requirements. Lydia Torne, with law firm Simmons & Simmons LLP, explores the prospects.

Regulation Digital Health Distribution

India’s Top Regulator ‘Relieved Of Post’; Temporary Head In Place

India has appointed a temporary head for its Central Drugs Standard Control Organization, after terminating GN Singh’s position.

India Policy & Regulation

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

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

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

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

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

Quality Control & Compliance Explore this Topic

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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

'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

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

Commercial Explore this Topic

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Hindsight 20/20: Yossi Gross

Hindsight 20/20 is a Q&A feature where medtech industry veterans share their experience taking diverse businesses – be they start-ups or publicly listed entities – from strength to strength and navigating through times of crises. In this installment, Yossi Gross, Israeli serial entrepreneur and founding partner of medtech incubator and investor Rainbow Medical, explains why getting regulators involved in your clinical strategy sets you on the right path to success and shares a hard lesson he learned about letting a strategic partner have too much control.

Hindsight 20/20 Business Strategies StartUps and SMEs

Sinclair Drops InstaLift US Distributor

Sinclair Pharma is bringing an early end to a four-year contract with ThermiGen LLC, the exclusive US distributor of its non-surgical "one-stitch" facelift Silhouette InstaLift following lackluster re-order rates. 

Commercial Companies

J&J Adds To Robotic Focus With French Firm Acquisition

Johnson & Johnson has purchased Orthotaxy, a French developer of software-based surgical technologies. The company is developing a surgical robot that could be used for knee replacements.

Deals Surgical Procedures

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

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

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

Clinical R&D Explore this Topic

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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. 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

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

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
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