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Why IVDs Will Be Urgently Jostling For Notified Body Attention

With the EU's Medical Device Regulation and IVD Regulation having been drafted, adopted and now taking effect at the same time, the EU IVD sector often seems to be lagging behind its bigger medical device brother. Now it must fight to the front of the queue to get help from increasingly pressured notified bodies to survive through the transition process.

In Vitro Diagnostics Europe Policy & Regulation

Successful Selling: Adapting The Distributor Sales Model For A Changing Marketplace

There are myriad reasons for companies to enlist distribution partners to sell their products and this sales strategy continues to be the preferred route for many. However, as sales models evolve with the changing health-care environment, the traditional distributor sale model also needs to adapt. In the first of a four-part series focused on sales strategies, Bret Caldwell of global sales and marketing strategy consultants ZS outlines several key steps to improving your distributor sales channel to make it more robust to the new marketplace.

Distribution Business Strategies Commercial

DEVICE DEBUTS: Product And New Indication Launches From Medtronic, Strkyer, Siemens, And More

This month's edition of Device Debuts includes new product launches from Medtronic, Cochlear, Qualcomm, Titan Spine, Stryker, Philips, Nuance, Nevro, Siemens, Vortex BioSciences, ResMed, Respircardia, and others.

Innovation Companies Commercial

Device Week, Nov. 23, 2017 – Implementing The EU Regs

In this week's podcast, Medtech Insight's Amanda Maxwell talks about where things stand and the big challenges ahead for implementation of the EU Medical Device and IVD Regulations.

Regulation Europe Medical Device

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Policy & Regulation Explore this Topic

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EU Industry Tells Authorities To Get Their Act Together As Pressure Builds

Six months into the transition period for the EU's Medical Device and IVD Regulations, the structures and resources needed to help medtech companies comply with the new rules are still far from being in place. Industry association MedTech Europe's concerns are mounting.

Medical Device Policy & Regulation Policy

Lab Sector Vs. CMS Battle Heats Up As Medicare Agency Moves Forward With 2018 Rates

Test-makers and labs say the agency is missing large swaths of the market in making its "market-based" lab payment calculation, but CMS stands by its data, and finalized 2018 lab fee schedule rates. Could next steps be in Congress, or the courts?

Commercial Market Access Reimbursement

US FDA Is Dedicating A 'Patient Affairs' Staff Without A Formal Reorg

The agency's principle deputy commissioner says it's creating a patient affairs staff, but will not undergo a reorganization.

FDA Regulation

QUOTED. Nov. 23, 2017

Check out what AdvaMed CEO Scott Whitaker had to say about the efforts by the US Congress to repeal the device tax (hint: he's not happy).

Leadership Legislation

Warning Letter Roundup & Recap – Nov. 21, 2017

US FDA did not release any device-related warning letters the week of Nov. 21.

Device Warning Letters Regulation

QUOTED. Nov. 21, 2017

Check out what King & Spalding's Steve Niedelman had to say about device-makers being extra careful about what they tell a US FDA investigator.

Compliance FDA

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

Quality Control & Compliance Explore this Topic

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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

Compliance Corner: 20 Things You Should Never Say To An FDA Investigator

Medical device manufacturers might be tempted to defend themselves during a US FDA inspection. But longtime industry insider Steve Niedelman says there are 20 instances in which firms should remain tight-lipped.

Compliance Compliance Corner

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Cardiovascular Divisions Boost Medtronic's FYQ2 Top-Line As Hurricane Recovery Continues

Medtronic's revenue of $7.1bn for the second fiscal quarter of 2018 was down 4% year-over-year on an as-reported basis, but up 4% on a comparable constant-currency basis. –It would have been even greater if not for the hurricane that hindered manufacturing operations in Puerto Rico, the company reported Nov 21.

Sales & Earnings Cardiology Companies

QUOTED. Nov. 22, 2017

Check out what Boston Scientific's Pierre Chauvineau had to say about the US possibly being the firm's first go-to market for new products.

Cardiovascular Cardiology

China's MicroPort Bags A Bargain In LivaNova's CRM Unit

Some two months after disclosing its intention to cast off its struggling cardiac rhythm management unit, LivaNova has struck a deal to sell the business to its Chinese joint-venture partner MicroPort Scientific at a discounted price of $190m.

Cardiology Deals

Anti-Infection Material Start-Up Taps Pharma Veteran For Chairman

Briston University spin-out and developer of an antimicrobial material Pertinax Pharma has appointed Nigel Brooksby as chairman.

Appointments 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

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

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Researchers Call For More FDA Credit In Device Studies

A paper recently published in JAMA Cardiology argues that acknowledging US FDA in published device research could serve as an assurance of study quality and provide important context to physicians.

Clinical Trials Research & Development Regulation

US FDA Approves Device To Aid Cataract Patients

Approved by US FDA on Nov. 22, a new intraocular lens from RxSight is designed to correct residual refractive errors after cataract surgery and enable clearer vision.

Ophthalmology Approvals

Clearblue Connects Peak Fertility Data To Smartphone App

Procter & Gamble's connected Clearblue tracks a user’s personal hormone profile and sends data to a smartphone, typically alerting them about the four, or more, best days to get pregnant. It provides a window into fertility two days longer than other ovulation testing brands, the firm says.

Digital Health Innovation

US FDA Approves First Telehealth Option To Remotely Program Cochlear Implants

FDA approved a PMA supplement to remotely program sessions for Cochlear Americas' Nucleus Cochlear Implant System, heralding the feature as the first programming telehealth option for the hearing implants.

Ear, Nose & Throat Approvals

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