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EU MDR One Year Out: Reg Demands Forcing European Business Closures

The impact of high regulatory demands on the innovation potential of medtech companies in Europe was a sub-theme of last week’s MedTech Forum in Paris. But it’s not a theoretical risk, for coinciding with the Forum was a decision by Swiss company Jossi Holding to close its orthopedics subsidiary.   

EU Germany Europe

US FDA Warns Of Potentially Deadly DIY Diabetes Devices, Algorithms

As the use of "hacking devices" is gaining in popularity among diabetes patients, the US Food and Drug Administration is warning against using products not approved by the agency. Regulators say the practice almost killed one patient.

US States Digital Health Regulation

No Shocks Expected In EU Quality Guidance For Drug-Device Combinations

Long-awaited draft EU guidance on the quality requirements for integral and non-integral drug-device combination products will be published very soon.

Combination Products Quality Regulation

Lawmakers Question Effectiveness Of Free Sample Reporting Requirements

The US House Energy and Commerce Committee’s health subpanel mostly heard arguments against a bill that would require device makers to report the value of free samples they give out to health care providers.
Legislation Regulation Policy

QUOTED. 21 May, 2019. Ian Crozier.

Medtronic PLC is encouraged by results of a 21-patient first in-human pilot study with its substernal Extravascular Implantable Cardioverter Defibrillator. See what the study's investigator Ian Crozier of Christchurch Hospital in New Zealand said about it here:

Quoted Clinical Trials Innovation

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Policy & Regulation Explore this Topic

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Execs On The Move: New Tech Talents At Midmark & Dentsply Sirona, Wright Medical Promotes Strategy Exec

Johnson & Johnson digital surgery VP took CTO job at Midmark Corp. while similarly Merck KGaA SVP is now CTO of dental equipment maker Dentsply Sirona. Wright Medical Group promoted strategy and development executive to chief digital officer.

Appointments Commercial Medical Device

Warning Letter Roundup & Recap – 21 May 2019

Two automatic external defibrillator manufacturers and an orthopedics firm were the subjects of the three warning letters US FDA released this week.

United States Medical Device Quality Control

QUOTED. 23 May, 2019. Armin Ritzhaupt.

Much-awaited draft guidance on quality expectations for EU marketing authorization applications for integral and other types of drug-device combination products is due to be published for public consultation shortly. See what the European Medicines Agency's Armin Ritzhaupt said about it here:

Quoted Combination Products

FDI In India’s Medical Devices Sector Plunges, Experts Blame Price Controls

FDI in India's medtech sector has plunged to levels last seen before investment in the sector was liberalized and the Indian association representing global medical technology firms says government-imposed price controls are to blame.

India Pricing Strategies

EU Officially Designates Second Notified Body Under The MDR: TÜV SÜD Enters Center Stage

TÜV SÜD, headquartered in Germany, is the second notified body to be officially designated under the EU MDR. Is this good news going to significantly lessen medtech industry’s concerns over delays in accessing the new, tougher regulatory system for medical technology, with time running seriously short?

Medical Device Europe

How Would Clinical Investigation Requirements In The UK Be Impacted By A No-Deal Brexit?

To what extent would a no-deal Brexit from the EU threaten the future of clinical investigations being carried out in the UK? Sarah Sorrel and Sabine Koudsié of MedPass International explain.

Medical Device Europe

QUOTED. 22 May, 2019. US FDA.

The US FDA is warning diabetic patients that using unauthorized devices and unauthorized algorithms could have serious consequences. This comes after a patient who used such devices nearly died. See what the agency said about the serious adverse event here:

Quoted Digital Health

EU Authorities Consider Reviewing Products If Notified Body Shortfall Threatens Product Availability

Industry has been hammering away the message that the medtech system is heading for crisis. A fallback plan is under review as authorities share industry’s concerns. Authorities are considering reviewing some products, among other solutions.

Medical Device Europe

Quality Control & Compliance Explore this Topic

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FDA Quietly Sunsetting Summary Reporting Program For Adverse Events, Readies Public Release Of Millions Of Pre-2017 Summarized MDR Reports

The US FDA will turn the lights out on its 22-year-old Alternative Summary Reporting Program for adverse events at the end of May, the agency tells Medtech Insight. But it's the FDA's upcoming online release of millions of summarized Medical Device Reports sent to the agency between 1998 and 2017 that could have the tongues of industry – and the public – wagging.

FDA Safety

FDA Issues Update On Essure Adverse Events, Postmarket Study

The US FDA has released a new batch of information from its ongoing postmarket surveillance of Bayer’s Essure birth control device. Last year saw the number of Medical Device Reports filed about the device revert to historic norms, while more progress was made in shaping the ongoing Sec. 522 postmarket study.

Safety FDA

Help Wanted: FDA's Office Of Regulatory Affairs Looks To Plug Investigator Vacancies, Begins 'Succession Planning'

The US FDA's Office of Regulatory Affairs – which handles all of the agency's field activities – is "sitting on a lot of vacancies right now," FDA official Jan Welch said at MedCon 2019. Here's what ORA wants to do to nab and retain staff, and plan for the next generation of senior supervisors.

FDA Enforcement

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UNTOUCHED Trial Shows Low Complication Rate With Boston Scientific’s Emblem S-ICD

Procedural outcome data of UNTOUCHED of the Emblem subcutaneous implantable cardioverter defibrillator show low perioperative complication rates and high conversion efficacy of induced ventricular fibrillation in a high-risk patient population.

Clinical Trials Research & Development Cardiovascular

Medtech Tips: Expert Pointers For Protecting IP In The Medtech Space

In this edition of Medtech Tips, Ilya Kazi, a partner at intellectual property firm Mathys & Squire LLP, provides top tips on what medtech businesses should do in order to help protect their IP and avoid risks to their inventions. 

 

Commercial Medtech Tips

Market Brief: PBV Systems Fastest-Growing Segment In Global Surgical Heart Valve Management Market

The worldwide market for surgical heart valve products is expected to stay relatively flat, reaching $2bn in sales by 2023. The heart valve repair and replacement segments are expected to see small losses while the much smaller PBV systems market will grow at a CAGR of 12.7% by 2023, benefiting from a trend toward minimally invasive procedures.

Innovation Market Intelligence

Veeva Eyes Opportunity In Medical Devices To Grow Cloud Technology Business

Cloud-based software company Veeva wants to grow it business in medical devices to meet industry demand for better data management systems. The company is already a major provider of software services to the pharmaceutical industry.

Compliance Life Cycle Management

Improving Quality And Outcomes Through Digital Heart Health Management

Digital health technologies can help cardiology practices and departments and hospitals meet the growing demand of improving care quality and patient outcomes,according to Alexis Bernstein, Senior Director of Client of Strategy and Operations at Wellframe, a Boston-based health information technology company.

Digital Health Innovation

Acutus Announces Four Deals To Expand Its Reach Into Electrophysiology

Acutus announced a deal to acquire Rhythm Xience, and new strategic partnerships with Peerbridge Health, Cardiac Designs and MedFact, to offer more electrophysiology products that complement its AcQMap multi-electrode electrophysiology mapping catheter system.

Companies Deals

QUOTED. 17 May 2019. Alexander Weber.

Alexander Weber, assistant professor of Sports Medicine in the USC Department of Orthopedic Surgery, told Medtech Insight that suture anchors have benefitted from technological advancements. Check out his comment here.

Quoted Innovation

Clinical R&D Explore this Topic

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FDA Says Abiomed’s Impella RP Pump Works For ‘Appropriate Patients’

In a letter sent 21 May, the US FDA tells physicians the benefits of Abiomed’s Impella RP right-heart circulatory support device outweigh the risks in appropriately selected patients. In February, the agency warned doctors that the postmarket study of the device showed worse survival than the premarket clinical trial.

FDA Safety Cardiology

Device Week, 22 May 2019 – Former Verb Surgical CEO Talks About Digital Surgery, Encourages Medtech To Think Big

In this edition of Device Week, Medtech Insight's Catherine Longworth reports on her experience at the BIOMEDevice meeting in Boston, where she talked to CEO Scot Huennekens, the former CEO of Verb Surgical, the robotics start up formed by Google and Johnson & Johnson’s Ethicon. Verb is combining robotics, advanced instrumentation, advanced visualization, data analytics and machine learning to create a platform for digital surgery, rather than trying to compete with the existing surgery robotics companies like Intuitive Surgical.

Device Week Digital Health

Medtronic’s Extravascular ICD Stops Ventricular Arrhythmias In Pilot Trial

In a 21-patient first in-human pilot trial, Medtronic’s Extravascular Implantable Cardioverter Defibrillator (EV ICD) system successfully terminated induced ventricular arrhythmias in 89.5% of patients and achieved pacing capture in 95% of patients.

Clinical Trials Innovation

NICE Endorses PICO Negative Pressure Wound Dressings

The National Institute for Health and Care Excellence recommends that UK’s National Health Service adopt Smith & Nephew’s PICO negative wood dressings as an option for closed surgical incisions in high-risk patients.

United Kingdom Cost Effectiveness

Abbott To Provide Devices To NIH’s BRAIN Initiative

Abbott has agreed to provide directional deep brain stimulation, spinal cord stimulation, and dorsal root ganglion therapy devices to help NIH study treatments for chronic pain and progressive movement disorders like Parkinson's disease.

Clinical Trials Deals

Vagus Nerve Stimulation Ear Clip Reduces Atrial Fibrillation In Sham-Controlled Trial

Results of the TREAT AF trial showed low-level transcutaneous electrical stimulation of the auricular branch of the vagus nerve through the tragus of the patient’s ear reduced atrial fibrillation burden over six months.

Clinical Trials Innovation

CMR Surgical Encouraged By First In-Human Series With Versius Robot

There have been no adverse events reported from the first 30 laparoscopic surgeries performed with CMR Surgical's robotic platform Versius in a hospital in India.

Surgery Surgical Procedures
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