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AdvaMed CEO: Less Optimistic On Full Device Tax Repeal By Deadline

In an exclusive sit-down with Scott Whitaker, the head of the largest medical device lobby group tells Medtech Insight why pharmaceutical companies should be concerned about Trump HHS Secretary nominee Alex Azar, his frustration with Congress' device tax repeal efforts, the growing likelihood of another temporary device tax moratorium and more. Listen to the podcast.

Policy Legislation Medical Device

'Old-Fashioned' Medical Device Regulation? New Regulatory Regime For EU Medtech In Wings

As medtech grapples with the overwhelmingly complex implementation of the EU's new Medical Device and IVD REgulations, one legal pioneer, Oxford's Christopher Hodges, says it's time to think differently.

Medical Device Europe International

Exec Chat: How Verb Surgical Will Deliver On Surgery 4.0

The digital revolution looks to be sweeping across different industries, which are now fully embracing technologies around connectivity, big data and artificial intelligence to drive innovation and better outcomes. Health care seems to have come late to this party, but changes are happening as medtech companies make a concerted effort to incorporate the advanced computing capabilities needed to turn devices into smart machines that are constantly learning and adapting. Surgery is one area that will benefit from these smart technologies and Scott Huennekens, CEO of Verb Surgical, tells Medtech Insight how the J&J/Verily joint venture aims to make this happen.

Surgical Procedures Innovation Companies

QUOTED. Nov. 20, 2017

Check out what Verb Surgical CEO Scott Huennekens had to say about innovation in an era of tough medtech competition.

Surgical Procedures Surgery Innovation

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Policy & Regulation Explore this Topic

Set Alert for Policy

Devices Addressed In US FDA's New Regenerative Medicine Framework

The framework includes two draft guidance documents and two final guidances. One of the drafts, which focuses on the regulation of devices used with regenerative medicine, implements a provision of the 21st Century Cures Act and strongly suggests that most of these products will be regulated via class II.

Regenerative Medicine Regulation Medical Device

Medtech To Benefit From 20% Corporate Rate, Tax-Free Foreign Transfers In Pending US Tax Bill

Medical device firms will benefit from a Republican tax bill that has passed the full US House and a key Senate committee. The bill lowers the corporate tax rate to 20% from a maximum of 35%, treats foreign-earned intangible income at a favorably low rate of 12.5%, and permits tax-free transfers of intangible corporate property, such as patents, from foreign firms to US parents.

Legislation Trade United States

New EU Regs: Clues To Which Notified Bodies Will Be Designated First

The race is on for companies to be among the first to CE mark their devices under the new EU regulations. Much will depend on which notified bodies are designated first; and national competent authorities play a key role.

Europe Medical Device

Combining EU Notified Body MDR/IVDR Assessments: Can It Speed Things Along?

As the date that EU notified bodies can submit for designation under the new regulations rapidly approaches, can EU designating authorities audit notified bodies against the MDR and IVDR at the same time to improve efficiency? And can notified bodies audit against the legacy directives alongside the regulations to minimize worst-case logjams?

Medical Device Europe

Despite 510(k) Software Guidance, US FDA's Hands May Still Be Tied

While a recent final guidance when a 510(k) is needed for software changes is helpful, a key industry lobbyist says it doesn't do enough to address the bigger issue of allowing FDA more discretion to let software medical device-makers update their products quickly without burdensome agency oversight.

Regulation Digital Health

FDA Beefs Up Its UDI Direct-Marking Preferences In Final Guidance

US FDA's device center has made some clarifications to the way it would like to see sponsors directly mark medical devices intended to be reprocessed and reused, and it has beefed up its preferred approach to Unique Device Identification labeling in a final guidance on direct UDI marking released Nov. 16.

Regulation Quality Control

Political Bargaining Intensifies In Final Days Before Vote On EMA’s New Home

In the run-up to next Monday’s vote on the European Medicines Agency’s future home, political horse-trading and vote-swapping behind the scenes makes it difficult to predict which EU city will win the prized agency.

Regulation Europe

Neurostimulator Is First Device Marketed To Reduce Opioid Withdrawal Symptoms

FDA used its de novo pathway to clear Innovative Health Solution's NSS-2 Bridge – the first device for use in helping to reduce the symptoms of opioid withdrawal – as a class II device.

Neurology Regulation

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

QUOTED. Nov. 17, 2017

Check out what US FDA device center chief Jeffrey Shuren had to say about changes that could come to the joint FDA/MDIC "Case for Quality."

Quality FDA

FDA Beefs Up Its UDI Direct-Marking Preferences In Final Guidance

US FDA's device center has made some clarifications to the way it would like to see sponsors directly mark medical devices intended to be reprocessed and reused, and it has beefed up its preferred approach to Unique Device Identification labeling in a final guidance on direct UDI marking released Nov. 16.

Regulation Quality Control

Reimagining The 'Case For Quality': FDA Looking At More Hands-Off Approach, CDRH Director Shuren Says

In an effort to step back some from its role as a ringleader for the Case for Quality initiative, US FDA wants to create a "collaborative community" so various industry stakeholders can have a say in the six-year-old scheme that aims to drive a quality mindset throughout device manufacturing organizations.

Quality Control FDA

Commercial Explore this Topic

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Exec Chat: An Inside Look At Intuitive Surgical

Medtech Insight recently caught up with a top executive at robotic surgery leader Intuitive Surgical at the Exponential Medicine Conference in San Diego. Check out our podcast interview with VP of Strategy, Catherine Mohr, about future plans at her company and much more.

Commercial Analysis Surgical Procedures

J&J Wins Mesh Case, But Slammed With $247m Penalty On Hips

The company’s Ethicon business unit was cleared on allegations a pelvic mesh product had injured a Texas woman, while a jury in a separate trial issued a $247m award to patients claiming injury from the DePuy Orthopaedics Pinnacle hip.

Medical Device Gynecology & Urology

Catheter Patent Case Moved To Minnesota

A Milwaukee cardiologist’s patent claim against Medtronic, Boston Scientific and St. Jude has been refiled in Minnesota after a Wisconsin court dismissed it on jurisdiction questions raised by a recent Supreme Court decision.

Medical Device Cardiology

Catheter Patent Case Dismissed On Jurisdiction Question

A Milwaukee cardiologist’s patent claim against Medtronic, Boston Scientific and Abbott has been dismissed on the grounds the companies didn’t have a big enough presence in Wisconsin.

Medical Device Intellectual Property

UK's Brexit Article 50 Talks Will Tackle Health Care In December

The European industry association MedTech Europe (MTE) issued its Brexit position paper last week, in good time for the UK's article 50 negotiators to heed its warnings about the fall-out that a "hard Brexit," in which the UK emerges from the talks with no trade deal, could have on the business of health care and patient well-being, in the UK and beyond.

United Kingdom Brexit

M&A Analysis: October Notches 30 Deals In Big M&A Boom

The medtech M&A deal count soared in October with a total of 30 deals announced and closed in the month. It was an especially busy month for the orthopedics sector, with a number of high profile deals inked.

M & A Deals

Amazon's Medtech Retail Plans: Analyst Finds More Evidence

Based on documents obtained by Jefferies, analysts say the view is clearer of Amazon's plans to conquer the medical device supply sector rather than challenging pharmaceutical retailers such as Walgreens and CVS for the time being.

Commercial Business Strategies

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

US Approvals Analysis: Original PMA Slowdown, De Novo Upswing Among Recent Trends

The volume of original PMAs coming to US FDA for review is down recently, while panel-track supplement, de novo and 510(k) volumes are up. October, meanwhile, was a relatively light month for novel device approvals, but better-than-average for 510(k) clearances.

Approvals Innovation Research and Development Strategies

Stryker's DAWN Thrombectomy Trial Could Also Help Medtronic And Penumbra

Results of the DAWN trial show that endovascular thrombectomy with Stryker's Trevo produces better outcomes than medication alone when used in certain patients who experienced an ischemic stroke. The results could provide a boost to Stryker as well as Stryker's competitors in the mechanical thrombectomy market, including Medtronic, Penumbra.

Clinical Trials Research & Development

Biovica's DiviTum Test Speeds-Up Breast Cancer Diagnosis In Study

Results from a Swedish study that will be presented at the San Antonio Breast Cancer Symposium in December show that Biovica's DiviTum blood-based biomarker test provides a valuable marker for accurate prognosis of metastatic breast cancer therapy after just one month.

Clinical Trials Research & Development

TCT 2017: ORBITA Ignites Controversy, Twitter Storm Over Stents, But Analysts Expect Little Impact

Results of the ORBITA trial, the first sham-controlled trial of percutaneous coronary intervention with drug-eluting stents in patients with stable angina found no difference in outcomes between the sham-control group and the group PCI-treated group. The results have triggered a lot of discussion and argument among physicians about the role of stents in stable angina patients, but securities analyst do not expect the results to have much impact on the drug-eluting stent market in the forseeable future.

Health Technology Assessment Cardiovascular

The First Sham-Controlled PCI Trial In Stable Patients

More details about the controversial ORBITA trial.

Clinical Trials Health Technology Assessment

Global Approvals Analysis: Diabetes, Drug-Eluting Stents Lead List Of Non-US Approvals in October

The CE Marks recorded in October include Abbott's new version of Xience and Medinol's BioNIR drug-eluting coronary stents, plus 18 other devices approved in eight different territories.

Approvals Innovation

Starts & Stops: Medtronic's TMVR News Closes Big Month For Trial Announcements

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial announcements, initiations, completions, and suspensions each month. This month's edition, covering a long list of device trial updates that occurred between Sept. 24 and Oct. 31, is headlined by Medtronic's APOLLO US pivotal trial of the Intrepid transcatheter mitral valve.

Clinical Trials Innovation