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Challenges Prompt Canada To Adapt MDSAP Transition Plan

Health Canada is making it easier for device manufacturers to transition to the Medical Device Single Audit Program by the 2019 deadline.

Manufacturing Quality Control Canada

New Safety Framework Mixes Current Efforts, New Investments At US FDA

In a new "action plan," FDA is stitching together a plethora of ongoing and proposed initiatives to help spur product safety and quality efforts through increased regulatory authority and more incentives for device-makers.

FDA Quality Cybersecurity

Exec Chat: Breaking Into Asia? Think Long-Term And Engage, Accuron Medtech Chief Advises

For many medtech companies, Asia still holds significant opportunity compared to the persistent slow growth in the more mature US and European markets. But those looking to do business in this region need to plan long term. The biggest mistake is to think you can make a quick buck, says Abel Ang, CEO of Accuron Medtech, Southeast Asia's largest medical device pure-play. The Singapore-based industry veteran shares with Medtech Insight the lessons he learned from his time building businesses for medtech multinationals in APAC and other international markets. He also gives tips from his current experience introducing a disruptive technology to this region.

Asia Pacific Market Access Business Strategies

Global Device Approvals: Q1 Snapshot

The first quarter of 2018 brought 90 approvals from outside the US, including 56 in Europe, according to Medtech Insight's Approvals Tracker. The biggest category of approvals was cardiovascular, with several new drug-eluting stents and heart-valves coming through during the first three months of the year. Check out our infographic spotlighting the Q1 trends.

Approvals Clinical Trials Innovation

Device Week, April 19, 2018 – An FDA Safety & Quality Plan, Device Cybersecurity Galore, And A Pivotal Medtronic Clinical Trial. Oh My!

In this week’s Medtech Insight podcast, we discuss US FDA Commissioner Scott Gottlieb’s big plan to boost medical device safety and quality, important news regarding cybersecurity, and the latest on a Medtronic clinical trial.

Device Week Quality Safety

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Policy & Regulation Explore this Topic

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Gottlieb Defends US FDA 2019 Budget, Device Safety Plan In House

Members of a US House Appropriations Subcommittee interrogated FDA Commissioner Scott Gottlieb on the agency's proposed 2019 budget and his newly released device safety plan. One fierce critic, Rep. Rosa DeLauro, D-RI, attacked Gottlieb's efforts to allow third-party certifiers to approve device quality manufacturing processes, and said his safety plan looked like a "high-risk" action plan.

FDA Legislation Policy

South Africa Looks Ahead To Improved Medtech Regulatory Climate

The long-awaited South Africa Health Products Regulatory Authority (SAHPRA) came of age in February 2018, replacing the Medicines Control Council. The authority has inherited a major backlog of drug-products regulatory work, but the local medical devices industry has high hopes of better, faster regulation, and a higher profile on the international front too.

South Africa Regulation Medical Device

QUOTED. April 20, 2018. Rosa DeLauro.

US Rep. Rosa DeLauro had a tense exchange with US FDA Commissioner Scott Gottlieb over the agency's handling of Bayer's Essure birth-control device. Check out what the Rhode Island democrat said here.

Quoted FDA

FDA, CMS Will Use Parallel Review For Pain-Control Alternatives To Opioids, Medicare Official Says

The Medicare agency is working with US FDA on a parallel review process for non-addictive medical device pain control products and non-opioid drug alternatives to treat chronic pain, Kimberly Brandt, a CMS deputy administrator, told the Senate Finance Committee April 19.

Reimbursement Regulation

Abbott Issues New Cybersecurity Patch For Cardiac Devices

After Abbott recently settled a case against short-seller Muddy Waters, the company has put out a second cybersecurity patch for certain St. Jude radio-frequency enabled cardiac devices to stop potential hackers from harming patients.

Cybersecurity Digital Health

QUOTED. April 18, 2018. Tanya Vogt.

South Africa is undergoing a transition to a new regulatory regime. Check out what South African Medical Technology Industry Association's Tanya Vogt had to say about it here.

Quoted South Africa

German Medtech Industry Takes Aim At EU-Wide HTA Bid

The EU Council is scheduled to debate the European Commission's EU-wide health technology assessment proposal today, but opposition to the concept within medtech circles has started to mount, notably in Germany.

Germany Health Technology Assessment

Warning Letter Roundup & Recap – April 17, 2018

Medical Device Reporting violations noted at maker of the SynCardia Temporary Total Artificial Heart System in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA

Quality Control & Compliance Explore this Topic

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How To Interpret EN ISO 13485 To Meet New Regs: Pivotal EU Document Published

A new document has just been published to help manufacturers and notified bodies meet the quality system requirements of the new EU Medical Device and IVD Regulations. BSI's Paul Sim explains its value.

Standards Quality Control

FDA Sends Record-Low Warning Letters To Device-Makers In 2017 As Agency Takes More Personalized Compliance, Enforcement Tack

Medical device firms were issued 35 quality-related warning letters by US FDA last calendar year – the lowest number recorded since the agency's Quality System Regulation came into force in 1996. Officials in FDA's device center stressed in an interview with Medtech Insight that there's no specific reason why so few letters were mailed to companies in 2017, although they said the agency's ongoing compliance and enforcement outreach to device-makers might have played a role in last year's anemic count. Also: Might FDA apply "least burdensome" concepts to its warning letter and close-out processes?

FDA Enforcement

When A Recall Hits, Embrace Your Regulator For The Common Good: Patient Safety

When a device-maker initiates a medical device recall, it's wise for the firm to work hand-in-hand with regulators to ensure that the product is removed from the market before it causes troubles for users. Chris Harvey of Stericycle ExpertSOLUTIONS offers tips in this Medtech Insight guest column for making sure that happens. He highlights five cardinal rules to ensure a smooth recall process.

Product Recalls Safety

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Medtech Money Flow: Weekly M&A and VC Deals, April 9-15, 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 April 9-15, 2018.

Financing Deals M & A

QUOTED. April 19, 2018. Abel Ang.

For device-makers that want to capitalize on opportunities arising from Asia's ever-burgeoning health-care systems, relationships are indeed critical to a successful APAC business strategy. Check out what Accuron Medtech CEO Abel Ang said about it here.

Quoted Asia Pacific

Boston Sci Wins Latest TAVR Patent Dispute Against Edwards

The European Patent Office sided with Boston Scientific on April 16 in agreeing to revoke an Edwards Lifesciences patent on a technology used in transcatheter aortic valve replacement (TAVR) devices.

Intellectual Property Legal Issues

Boston Scientific Bags nVision As M&A Roll Continues

Boston Scientific has expanded its gynecology/urology portfolio with the acquisition of nVision Medical, the maker of the first US FDA-cleared device designed to collect cell samples from the fallopian tubes for early ovarian cancer diagnosis. 

Commercial Deals

MDIC Offers Contract To Develop Cybersecurity Playbook

As the threat of cybersecurity vulnerabilities in medtech has grown, so has interest in tackling the problem from both industry and regulators. In an effort to assist in developing a manual to help companies manage threats, the public-private Medical Device Innovation Consortium is taking research bids.

Cybersecurity Digital Health

Device Debut: Philips, Digital China Health Push Teleradiology App To Chinese Market

Philips and Digital China Health, the largest provider of cloud-based healthcare services in China, have launched the Shinefly teleradiology application and services platform to help Chinese health-care providers manage their radiology workload and information output.

China Diagnostic Imaging

New Anglo-Sino Ortho Player On The Block With AK Medical-JRI Merger

The global orthopaedic implant market will have a new bulked-up Anglo-Sino player after China's AK Medical and the UK's JRI Orthopaedics have inked a merger deal.

Orthopedics M & A

Clinical R&D Explore this Topic

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Global Device Approvals, Weekly Snapshot: April 9-15, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.

Approvals Innovation Research & Development

OncoDNA's Biomarker Test Provides Useful Treatment Guidance In Trial

A new study sponsored by OncoDNA shows a combination of molecular tests could improve cancer treatment and help oncologists in routine clinical practice.

Clinical Trials Innovation

Victory From The Jaws Of Defeat: Angel Med Wrests Approval For Implantable Heart-Attack Monitor

A US FDA advisory panel unanimously voted down the AngelMed cardiac monitor two years ago. But venture-backed Angel Medical Systems was able to engage with the agency after the panel, and the firm ultimately achieved approval of the device designed to help detect heart attacks earlier. It’s a lesson in firms leveraging all the data they have at their disposal.

Approvals Advisory Committees

US Device Approvals: Q1 Snapshot

An infographic to spotlight US FDA device approval trends during the first quarter, January through March.

Approvals Innovation

Starts And Stops: April 9-16, 2018

Starts & Stops features noteworthy clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers the trial announcements between April 9 and April 16, 2018. This week's edition include trial announcements from Abbott, Johnson & Johnson, Biotronik and Medtronic.

Starts & Stops Research & Development

Harvard Cardiologist Tapped By Medtronic As VP Clinical Research And Analytics

Veteran cardiology device trial investigator Laura Mauri will join Medtronic as VP-Global Clinical Research & Analytics on Sept. 1, leading the development of new analytical and data science for the medtech giant.

Appointments Companies

Medtronic Confident Renal Denervation Trial Will Work This Time

US FDA has approved Medtronic's plan for the SPYRAL HTN Pivotal Trial, part of the SPYRAL HTN Global Clinical Program. SPYRAL HTN is a multi-phased clinical study strategy to establish the safety and efficacy of renal denervation with the Symplicity Spyral system to reduce blood pressure in patients with uncontrolled hypertension. The Spyral device and procedure, as well as the design of the SPYRAL HTN clinical trial, reflect lessons learned from SYMPLICITY HTN-3, the first sham-controlled trial of renal denervation, which famously failed to show a benefit of the procedure.

Cardiology Innovation
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