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FDA Takes 'STeP' Forward For Medtech Innovation With Safer Technologies Program Modeled On Agency's Breakthrough Pathway

People with non-life-threatening and reasonably reversible conditions will soon have access to innovative, early development-stage medical devices and device-led combination products thanks to the US FDA's upcoming Safer Technologies Program (STeP). STeP is modeled on, and is a complement to, the agency's popular Breakthrough Devices Program, an accelerated development pathway for devices that the agency finds could provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

FDA Review Pathway Guidance Documents

Brexit And UK Procurement: Be Ready For Day 1

There are six weeks or less for medtech companies to be ready to operate as well as they can under Brexit – assuming that it will take place at the third time of asking. The new NHS procurement scheme, already in place, is another potentially disruptive concept for UK companies to adapt to.

Brexit United Kingdom Policy & Regulation

FDA Debuts ‘Collaborative Communities’ With NESTcc, Optic Imaging Groups

The US agency is participating in collaborative communities centered around eye health and the development of real-world evidence, representing the first two of what the agency hopes will be at least 10 communities by the end of 2020.

FDA Regulation Medical Device

US Senate Recommends Funding For FDA Device Shop In 2020 To Support Cybersecurity, Virtual Trials

The US Senate Appropriations Committee passed FDA funding levels for 2020 on 19 September that would support medical device cybersecurity and medtech manufacturing, but a continuing resolution measure is waiting in the wings to provide the full Senate more time to consider the measure before the new fiscal year starts on 1 October.

Policy FDA Financing

Device Week, 20 September 2019 – Medtech Giants Sign Major Diabetes Partnerships

In this edition of Device Week, Medtech Insight’s Catherine Longworth chats to Marion Webb about two new major partnerships signed in the diabetes sector, and finds out more about ResMed’s growth strategy.

Device Week Diabetic Care Deals

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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Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found.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.

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Policy & Regulation Explore this Topic

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‘Big Data’ Poses New Product Recall Challenges, FDA Official Says

Officials with the US FDA discussed new challenges the information economy poses to the agency’s recalls process at a recent conference, as well as techniques manufacturers can use to better work with the agency’s recall staff.

Recalls FDA Safety

FDA Unveils Technology Modernization Plan To Better Handle ‘Tsunami’ Of Incoming RWE Data

The US agency has introduced a new action plan geared toward handling an expected incoming storm of real world evidence (RWE) data that companies will be submitting to support future device and drug approvals.

FDA Policy Regulation

Have EU Rules For Designating MDR Expert Panels Been Published Soon Enough?

Expert panels will play a vital role in the implementation of the EU’s Medical Device Regulation, including in the oversight of higher-risk medical devices. At last, there are signs that they could be set up in time.

Medical Device In Vitro Diagnostics

Two First MDR Certificates Issued – Are Floodgates Open For Mass Certifications?

The first certificates have now been granted to medical device-manufacturers under the EU’s new regulations coming into force next year. Is this a sign that the whole sector is going to be on time to meet the requirements of the new Regulations? Or is it already too late?

Medical Device Europe

Progress On EU MDR Standards Being Held Up By PPE Standards Process

Once the MDR is in force, current standards harmonized under the Medical Device Directive cannot be used to claim a presumption of conformity with specific requirements under the new Regulation. But updating these standards so they are harmonized under the MDR has hit a roadblock.

 

EU Regulation

QUOTED. 19 September 2019. Jeff Shuren.

Device-makers with less-than-stellar compliance history may soon be able to join a variation of the program by the US Food and Drug Administration that assesses a company's manufacturing maturity and quality. See what Jeff Shuren, who leads the FDA's Center for Devices and Radiological Health, said about it here.

Quoted Quality

Wave Of Overhauled FDA 510(k) Guidance Documents Aims To Streamline Reviews

The US agency has released four updated guidance documents aimed at providing more clarity on how it intends to review 510(k) applications. The FDA says the guidances are intended to reduce unnecessary burdens for its review staff and to help sponsors avoid wasting resources. We break down each of the docs and explain what your company needs to know.

FDA Guidance Documents

IMDRF Consults On Specific Requirements For Recognizing CABs

Medical device regulators around the world have proposed new guidance for designating conformity assessment bodies because requirements in existing international standards are too generic.

International Guidance Documents

Quality Control & Compliance Explore this Topic

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FDA Mulls Variant CMMI Maturity Model Program For 'Struggling' Device Companies

Device-makers that are shut out of the US agency's Case for Quality Voluntary Improvement Program (CFQ VIP) because of poor compliance histories may soon be able to join an alternative initiative that would use an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework to assess manufacturing maturity and quality.

Quality FDA

Warning Letter Roundup & Recap – 17 September 2019

In the only device-related warning letter released by the US FDA this week, the maker of Bounder wheelchairs was cited for premarket and Medical Device Reporting violations.

Device Warning Letters FDA

Q2 Recalls Snapshot: It's A Mixed Bag For Industry As Recall Events Jump Slightly And Recalled Units Fall Dramatically

There were 200 recalls initiated by device-makers in the second quarter of 2019, a 22% increase over Q1, when 164 were reported. Conversely, the number of recalled device units fell from 135 million in Q1 to 19.7 million in Q2 – a decrease of 85%. Check out our Q2 recalls infographic.

Recalls Safety

Commercial Explore this Topic

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DreaMed Receives Another FDA Clearance For AI-Powered Diabetes Software

Israeli firm DreaMed has scored a new US Food and Drug Administration clearance for its AI-based diabetes decision support system Advisor Pro. The clearance enables physicians to use the software for patients with type 1 diabetes using continuous glucose monitoring (CGMs) and blood glucose meters (BGMs).

Diabetic Care Commercial Companies

QUOTED. 20 September 2019. Eran Atlas.

Tel-Aviv, Isreal-based DreaMed Diabetes received another US Food and Drug Administration clearance for its AI-powered Advisor Pro software, which helps providers manage and optimize treatment for patients with type 1 diabetes. See what DreaMed's CEO, Eran Atlas, said about it here.

Quoted Diabetic Care

Execs On The Move: Marketing And Sales Appointments At Quest, SomaLogic And Immunexpress

Quest Diagnostics and SomaLogic, a protein biomarker discovery and diagnostics company, will each bring on a new chief commercial officer; Immunexpress, a sepsis diagnostics firm, hired a VP for market development and commercial operations; and more.

Appointments Commercial

TCT 2019: A Preview Of Late-Breaking Trials; Analyst Expectations

Interventional cardiologists can expect important updates on transcatheter valves and drug-eluting stents during this year's late-breaking trials presented at the annual Transcatheter Cardiovascular Therapeutics meeting next week. They include updates from Edwards Lifesciences, Medtronic, Boston Scientific and Abbott.

Clinical Trials Cardiovascular

QUOTED. 18 September 2019. Martin Frost.

UK robotics firm CMR Surgical landed $240m in a Series C financing round, which will propel its Versius robotic surgery system onto the market. See what CMR Surgical's CEO, Martin Frost, said about it here.

Quoted Surgery

CMR Surgical Bags $240M, Ready For Robotics Surgery Launch

UK robotics firm CMR Surgical has landed $240m from investors as it prepares to launch its robotic surgery system in Europe and India. The Series C raise is Europe’s largest private financing round in the medical technology sector to date.

Surgery Deals

QUOTED. 17 September 2019. Ardy Arianpour.

Seqster developed a technology platform that integrates data from electronic medical records, DNA and genomic information and fitness wearables into one place. See what Seqster's CEO, Ardy Arianpour, said about it here.

Quoted Start-up Spotlight

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Cardiac Dimensions’ Device Reduces Heart Failure In Trial

Results of the 120-patient, sham-controlled REDUCE FMR trial showed Cardiac Dimensions Carillon device can significantly reduce mitral regurgitation and left ventricular volume in patients with symptomatic functional mitral regurgitation.

Clinical Trials Research & Development Innovation

QUOTED. 13 September 2019. Andrew Holden.

The first large randomized trial of drug-coated balloons to treat hemodialysis arteriovenous access stenoses showed Medtronic's IN.Pact AV paclitaxel-coated angioplasty balloon produces superior outcomes compared to standard angioplasty balloons. See what one of the trial’s primary investigators, Andrew Holden, said about it here.

Quoted Clinical Trials

Abbott’s Machine Learning Algorithm Predicts Risk Of Heart Attacks In Trial

Results of a study in over 11,000 patients shows Abbott’s MI3 algorithm can risk-stratify patients with suspected myocardial infarction and help doctors decide which patients are most likely to benefit from earlier clinical decisions.

Clinical Trials Artificial Intelligence

US FDA Clears Smartphone Urine Test For Kidney Disease

The US FDA cleared a smartphone-based urine test for diagnosing chronic kidney disease. Israeli company Healthy.io developed the digital testing kit that enables smartphone cameras to act as clinical grade medical devices.

Digital Health Approvals

Medtronic’s In.Pact AV Drug-Coated Balloon Effectively Treats Hemodialysis Access Lesions In Trial

The In.Pact AV paclitaxel-coated balloon outperformed plain angioplasty balloons in the IN.PACT AV Access trial, the first large, multi-center randomized trial comparing a drug-coated balloon to standard balloon angioplasty in the treatment of hemodialysis arteriovenous access stenoses.

Clinical Trials Innovation

Newer Data Fades Paclitaxel Risk, Physician Group Says

A meta-analysis that seemed to show an increased mortality risk tied to paclitaxel-coated balloons and stents sent shockwaves through the device industry last year. But a more complete data review funded by nonprofit group VIVA Physicians may show that the issue has been overestimated.

Cardiology Commercial

Dreem Launches New Direct-To-Consumer Sleep Device In US

Dreem 2 is a biofeedback headband with seven sensors that measure brain activity, heart rate, respiration and movement that works with a mobile app to help users improve the quality of their sleep.

Clinical Trials Innovation
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