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ADA Exec Chat: Hiten Chawla, Medtronic's VP Of Global Marketing Discusses Diabetes Business Plans

At this year's American Diabetes Association (ADA) meeting in San Francisco, medtech giant Medtronic made several key announcements including a collaboration with Tidepool Loop, the start of a new patient trial to develop its next-generation hybrid closed-loop system and another trial to improve its sensor technology. Medtech Insight met up with Hiten Chawla, Medtronic's VP of global marketing for its diabetes business, to learn more about these plans.

Exec Chat Innovation Diabetic Care

Guidance Doc Tackles Biotin Interference In IVDs

Biotin is widely used to encourage skin and hair health. But high biotin levels can interfere with diagnostic tests results, leading the US FDA to issue a draft guidance doc on how manufacturers should address the issue.

Guidance Documents In Vitro Diagnostics Medical Device

'Burn Them Out, Turn Them Over': Add Auditor Exhaustion, 'Boutique' Approach To The List Of Notified Body Challenges

From not enough notified bodies and auditors, to a slew of new or updated international standards and regulations coming into force, the medtech industry is facing a number of NB challenges – and now they can add auditor burnout as a concern. "Because some of these notified bodies have such huge demand, they're burning people out really fast," industry expert Kim Trautman says, noting that device-makers can expect to see "boutique" notified bodies popping up over the coming decade. Also: Johnson & Johnson's regulatory director explains how the dearth of notified bodies and auditors is affecting the global medical products giant.

International Regulation Enforcement

ACell To Pay $15M To Settle Recall, False-Claims Allegations

Wound-care products manufacturer ACell Inc. has agreed to pay $15m to settle charges related to its MicroMatrix product. The company reportedly encouraged false claims to be filed and staged a recall of contaminated devices without alerting the FDA.

Enforcement Legal Issues Medical Device

Device Week, 14 June 2019: Genomic Spy Games?

In this week's Medtech Insight podcast, executive editor Shawn M. Schmitt and senior reporter Sue Darcey discuss recent reporting on efforts by US senators to control and stop Chinese researchers in the US from using their research jobs at the National Institutes of Health, and at American medical colleges and universities, to steal genomic data and share it with the Chinese government.

Device Week China United States

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Recent Tweets from Medtech Insight

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.

Read the Whitepaper

Policy & Regulation Explore this Topic

Set Alert for Policy

Asia Reg News: AHWP Catch-Up, Korea, Malaysia, Indonesia and Vietnam Updates

Part 1 of this month’s Asian Medtech Associations Regulatory Networking discussions features Asean medtech market developments and Asian Harmonization Working Party news. Part 2 was a guest presentation on the current Brexit and EU IVDR outlook. This feature is hosted by Medtech Insight, the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).

ASEAN Asia Pacific Medical Device

Just Three UK Medical Device Notified Bodies Left As LRQA Pulls Out

Medtech companies that have been loyal to LRQA could find themselves at a serious competitive disadvantage as the organization pulls out as a notified body for medical devices and IVDs, putting the whole medtech regulatory system under increased stress.

Europe Medical Device Brexit

US Legislators To Rein In Surprise Laboratory, Imaging, Other Health-Care Bills

The US House Energy and Commerce Committee’s Health Subcommittee held a hearing on 12 June on proposed legislation to end “surprise medical billing,” spurred in part by out-of-network laboratory and advanced imaging bills, while Senate HELP Committee leaders continued to promote their own draft Lower Health Care Cost Act, addressing similar issues.

Legislation Reimbursement

UK Medtechs Welcome Hospital Single Access Scheme For Credentialed Staff

The complex system of credentialing staff from medtech and other life sciences organizations who wish to access hospitals in the UK has been simplified, with a new, easier-to-use alternative coming into place on 30 July. The ABHI’s Andrew Davies explains the changes.

United Kingdom Medical Device

Two EU Competent Authorities Call For Review Of MDR Implementation Status By Year's End

Two EU member states have waded into the argument about the likelihood of the system needed for the implementation of the new MDR being ready on time and believe “options for solutions” need to be considered.

Medical Device Policy & Regulation

QUOTED. 13 June 2019. Simon Richards.

At this month's Asian Medtech Associations' Regulatory Networking event, concerns were raised that the IVD industry may be facing a false sense of security given that the EU IVDR deadline is two years later than that for the MDR. See what Simon Richards, board member and former chair of the British In Vitro Diagnostics Association (BIVDA), said about it here.

Quoted Regulation

After AdvaMed, Yared Takes Helm Of MDIC Board

CVRx CEO Nadim Yared has moved up on the board of directors at the Medical Device Innovation Consortium as its new chair. The public-private partnership group that formed in 2012 has been effective in working with the US Food and Drug Administration to develop new regulations.

Regulation Lobbying

Testing For Toxicity In Fertility Treatment Technologies

US regulators are proposing makers of fertility assistant devices first test their products on mice embryos in the lab to better understand any potential toxicity risk to human embryos and the viability of the fetus.

Regulation Approvals

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Warning Letter Roundup & Recap – 11 June 2019

In the only device-related warning letter released by the US FDA this week, a maker of duel lumen catheters was cited for quality systems, Medical Device Reporting and recall violations.

Device Warning Letters FDA

Warning Letter Close-Outs – May 2019

The US FDA released six device-related close-out letters in May.

Device Warning Letters FDA

FDA Misses Hoped-For May End Date For Problematic Summary Adverse Event Reporting Program

The US agency is still taking steps to shutter its Alternative Summary Reporting Program, despite an earlier soft commitment to end it by the end of last month.

FDA Safety

Commercial Explore this Topic

Set Alert for Commercial

Varian Grows Cancer Portfolio With Endocare & Alicon Acquisitions

Varian is expanding its cancer care solutions portfolio with two new acquisitions in the interventional oncology space. The medtech giant said it will pay $185m to buy Endocare Systems, based in Austin, Texas; and Alicon, based in Hangzhou, China.

Cancer M & A Deals

Execs On The Move: New Leadership At Medartis And Biom’up, And A Trio Of Advisors For Robocath

Internal surgical fixation company Medartis announces new CEO; chairman of surgical hemostatis firm Biom’up also takes on role as CEO after previous CEO steps down; cardiovascular robotic systems-maker Robocath strengthens medical board with three international experts; and more.

Appointments Commercial

QUOTED. 7 June 2019. Rebecca Parkes.

Glooko, a leader in diabetes management data, and T1D Exchange, a nonprofit research group, have formed a collaborative agreement to use Glooko's platform to link anonymized diabetes device data from tens of thousands of type 1 diabetes patients with patients' electronic health-care records. See what T1D's Rebecca Parkes said about it here.

Quoted Diabetic Care

Judge Gives Go-Ahead To Suit Involving Recalled Medtronic Device

A negligence complaint against a Texas hospital that implanted a patient with a recalled Medtronic spinal device can move forward, a state appeals court ruled.

Legal Issues Recalls

Glooko Inks Partnership Deal With Companion Medical To Integrate Insulin Pen Data

Glooko entered a partnership to integrate Companion Medical's InPen insulin data into Glooko's diabetes management systems.

Diabetic Care Deals

Innovator Spotlight: Vertos Plans To Expand Reach Of Minimally Invasive Lumbar Decompression

New professional consensus guidelines recommend Vertos Medical’s minimally invasive lumbar decompression (MILD) system as an alternative to epidural steroid injections for patients with lumbar stenosis. The company is planning to raise more capital to expand its commercial operation so it can reach more patients that could benefit from MILD.

Innovation Companies

Execs On The Move: New Hires At Cardio Firms Shockwave And HeartFlow, And A Commercial Placement At LifeScan

Shockwave Medical CMO brings experience from Boston Scientific Corp.; coronary artery detection firm HeartFlow chooses a CEO; blood glucose monitoring company LifeScan now has a former J&J Vision exec as head of marketing; and more.

Appointments Commercial

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Continuous Glucose Monitor From Senseonics Earns FDA Approval For ‘Non-Adjunctive’ Claim

Senseonics now can promote its Eversense continuous glucose monitoring system as a replacement for fingerstick testing to help patients make diabetes treatment decisions during the day, following FDA approval of a new non-adjunctive indication.

Approvals Research & Development FDA

Myriad Foresees Imporant Role For Genetic Testing In Pancreatic Cancer, Breast Cancer, And Beyond

The results of the POLO trial, showing a benefit of Myriad’s BRACAnalysis CDx companion diagnostic for AstraZeneca’s Lynparza (olaparib) to treat pancreatic cancer offer more support for the new guidelines from the National Comprehensive Cancer Network recommending genetic testing for all pancreatic cancer patients. Myriad also stands to benefit from the growing support for genetic testing of breast cancer patients.

ASCO In Vitro Diagnostics

Biotronik Addresses US CRM Market With Rivacor And Acticor, The Most Comfortable ICDs

The company recently launched six new implantable high-voltage cardiac rhythm management devices with the thin elliptical BIOshape to minimize the risk of skin erosion around the device pocket. Rivacor and Acticor also feature Biotronik's DX leadless atrial diagnostic technology, and MRI AutoDetect which automatically switches the device to a MR-safe mode when it enters a magnetic resonance imaging environment.

Approvals Cardiology

QUOTED. 12 June 2019. Tim Goodnow.

Senseonics will soon begin marketing its Eversense continuous glucose monitoring (CGM) system in the US as an alternative to fingerstick testing to help patients make diabetes treatment decisions throughout the day. See what CEO Tim Goodnow said about Eversense here.

Quoted Approvals

Global Device Approvals Snapshot: 4-10 June 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week’s approvals include the FDA’s approval of new non-adjunctive labeling for Senseonics’ Eversense continuous glucose monitor and a de novo for Innovative Health Solutions’ IB-Stim percutaneous electrical nerve field stimulator to treat pain associated with irritable bowel syndrome.

Approvals Innovation

FDA Approves The First Device To Treat Pain Caused By Irritable Bowel Syndrome

Innovative Health Solutions IB-Stim percutaneous electrical nerve field stimulator is indicated to aid the reduction of functional abdominal pain in patients ages 11 to 18 with irritable bowel syndrome when combined with other therapies.

Approvals FDA

ADA 2019: Real-World Study Shows Abbott's FreeStyle Libre CGM Reduced HbA1c Levels In Type 2 Diabetics

At this year's annual American Diabetes Association (ADA) conference, Abbott presented real-world data from its FreeStyle Libre CGM suggesting it reduces HbA1c in type 2 diabetics. Look for more ADA coverage this week.

Clinical Trials Approvals