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Medtech Insight

Open Payments: Zimmer, Medtronic Top List Of Spenders

By Elizabeth Orr 17 Jul 2018

Major medical device companies paid almost $1bn in consulting fees, royalties, research costs and other expenses to physicians in 2017, the most recent data release from the US Open Payments database shows. Zimmer Biomet reported the highest spending on general physician payments, while Roche and Medtronic topped the list of research spending.

Medtech Insight

Compliance Corner: Follow These 4 Tips From FDA's Maisel For A Better Pre-Market Experience

By Shawn M. Schmitt 17 Jul 2018

Bill Maisel – the director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health (among other titles) – says there are four things device-makers should do to make sure they succeed during the product-review process.

Medtech Insight

Inside Toyota's 'Cult' Car-Makers Quality VP Tells Device-Makers How To Adopt 4-Pronged Quality Strategy

By Shawn M. Schmitt 10 Jul 2018

Toyota Motor North America's Kristen Tabar told a roomful of medical device quality and regulatory professionals at a Case for Quality forum that they can infuse quality concepts into every nook and cranny of their firms by adopting the car-maker's quality strategy of reflection, education, celebration and planning. "I don’t want to make it sound like it’s sort of cult-y, but it’s kind of cult-y," Tabar quipped.

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US Starts Imposing China Medtech Tariffs, But Offers Path To Product Exclusions

By Sue Darcey 10 Jul 2018

Although the 25% tariffs initiated July 6 by the US Trade Representative will impact about $836m worth of medical technology entering the US from China, the administration late last week offered a process for gaining exclusions for specific products. AdvaMed members are “looking into” the process, the group said, and Medical Imaging and Technology Alliance members have already started to try to use it.

Medtech Insight

Brexit: Will UK Now Stockpile Devices? And Is It Certain The Country Will Continue With MDR?

By Amanda Maxwell 06 Jul 2018

UK starts to discuss emergency measures around devices as no-deal Brexit concerns mount. But it is still looking like the UK will continue to implement the Medical Device Regulation, in the short-term at least. Will it be a different matter for the IVD Regulation?

Medtech Insight

Mercy, J&J Partner To Evaluate Medical Devices

By Ferdous Al-Faruque 06 Jul 2018

As US FDA has been on a quest to encourage gathering more real-world data, companies like Medtronic and Johnson & Johnson seem to be hopping on the bandwagon with partnerships to gather and analyze how their products really perform.

Medtech Insight

ADA2018: Insulet Reports Positive Clinical Results For Omnipod Horizon, Limited Market Release Of Dash

28 Jun 2018

Insulet Corp. plans a limited market release in the second half of this year of its recently FDA-cleared Omnipod Dash Insulin Management System through the pharmacy channel. Results from the most recent clinical trial supporting the Omnipod hybrid closed-loop system were presented this week's American Diabetes Association meeting in Orlando.

Medtech Insight

SOPHiA Buys In More Bioinformatics Know-How For Cancer Genomics

By Catherine Longworth 21 Jun 2018

In a move to accelerate adoption of its AI-driven genomics platform, SOPHiA Genetics has acquired Interactive Biosoftware, the French developer of Alamut, a clinical decision support software used in genomic data interpretation.

Medtech Insight

Mock Audits: Has Ambiguity In EU Led To Unfair Advantage?

By Amanda Maxwell 21 Jun 2018

There's been confusion and conflicting opinions about notified bodies conducting mock audits on companies' documentation to prove conformity with the impending EU Medical Device and IVD Regulations. Has the lack of clarity led to different and unfair practices? Does it matter?

Medtech Insight

Procept BioRobotics Believes Aquablation Could Dominate BPH Treatment... If It Gets Coverage

By Reed Miller 14 Jun 2018

Results of the WATER II trial confirm that Aquablation is a safe and effective treatment of benign prostate hyperplasia for large prostates, and manufacturer Procept BioRobotics is confident the procedure will eventually displace all other prostate resection techniques because it is easy for surgeons to learn.

Medtech Insight

New Reasons Not To Use EU MDR's Four-Year Extension, But Comply Earlier Or Retire Products Instead

By Amanda Maxwell 14 Jun 2018

The new EU Medical Device Regulation offers companies an option to market CE-marked devices for an extra four years under current directives. But more hurdles are being identified that make this option less attractive.

Medtech Insight

Philips Buys Heart Imaging Tech Firm Set Up By Biosense Founder

By Tina Tan 06 Jun 2018

Philips is bulking-up its image-guided therapy portfolio with the acquisition of EPD Solutions, which has a recently CE-marked cardiac imaging and navigation system for ablation procedures to treat heart arrhythmias. EPD was founded by serial inventor and entrepreneur, Shlomo Ben-Haim, the man behind Johnson & Johnson's Biosense Webster business.

Medtech Insight

US Homeland Security Sees Rapid Growth In Device Cybersecurity Vulnerability Reports

By Ferdous Al-Faruque 06 Jun 2018

A center inside the US Department of Homeland Security has seen a massive spike in the number of potential medical device cybersecurity vulnerabilities that it has responded to in the past year. The government says it reflects better collaboration and disclosure policies in industry.

Medtech Insight

Conformity And Confidence: US FDA Seeks To Build Trust In PreMarket Standards Declarations

By David Filmore 30 May 2018

FDA hopes the Accreditation Scheme for Conformity Assessment pilot will make it easier to trust the declarations of conformity to standards that are made by device-makers in pre-market submissions, rather than having to ask a lot of time-consuming questions. ASCA, included in the latest FDA user-fee agreement, also has important implications for the agency's global harmonization efforts. But many questions remain about its value and viability; they were on display at a recent two-day workshop at the agency's headquarters.

Medtech Insight

UK Notified Body BSI Sets Out Clear Post-Brexit Paths As It Goes Dutch

29 May 2018

BSI tackles Brexit issues head-on with aim to allay fears and bring clarity while UK regulator, MHRA, remains reticent to do so. Its messages are relevant for all doing business in the UK