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mHealth Developer Works Around Traditional Reimbursement Barriers

Glooko says it has found more success by pitching its diabetes management app to self-insured employers and to payers as a tool they can implement to reduce spending, rather than by pursuing reimbursement in the traditional way. It's one model for the digital-health sector in the current health-care environment.

Digital Health Market Access Reimbursement

Medicare Finalizes NGS Test Coverage For Advanced Cancers, Drops Evidence-Collection Provision

The US Centers for Medicare and Medicaid Services March 16 said it will cover next-generation sequencing diagnostic laboratory tests for advanced cancers, broadening its final determination to cover use in relapsed, refractory and stage III cancers, while dropping "coverage with evidence development" conditions.

Reimbursement Market Access In Vitro Diagnostics

Exec Chat: Zimmer Biomet's EMEA Head On Facing The New Reality In Health Care

As Katarzyna Mazur-Hofsäss approaches her fifth anniversary as head of Zimmer Biomet's EMEA division, she chats with Medtech Insight about her concerns as medical device companies operating in Europe try to cope with the new regulatory environment and how the orthopedics giant is responding to new demands from health-care providers. 

Orthopedics Exec Chat Companies

Brexit To Force Large-Scale Review Of Medtech Contractual Arrangements Throughout EU

UK companies, and firms in the EU dealing with them, need to be prepared to renegotiate their relationships in the context of Brexit, lawyer Alison Dennis tells the sector.

Brexit Medical Device Europe

Device Week, March 15, 2018 – Israeli Medtech Industry, Glaucoma Week, February VC Deals Update

On this week's Device Week podcast, we discuss the medtech scene in Israel, the state of the glaucoma-therapy field, and the latest venture capital investments in medtech.

Device Week Analysis Israel

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Policy & Regulation Explore this Topic

Set Alert for Policy

FDA Works To Connect Cardiac Device Registries

US FDA is working with manufacturers, researchers and other stakeholders to assemble a comprehensive network of registries of cardiac device data. But cardiologists and device firms say the project faces multiple challenges.

Regulation Research & Development Cardiovascular

Abbott, Merck Like FDA's Plan To Amass More Summary Adverse Event Reports, But P&G Says There's A Better Way

While mammoth manufacturers Abbott Laboratories and Merck & Co. – along with device industry advocacy groups – are supporting the US agency's proposed Voluntary Malfunction Summary Reporting Program, Procter & Gamble Co. is urging FDA to think twice. In comments to the agency, P&G's principal scientist says the program, which will allow firms to submit Medical Device Reports to FDA quarterly in a bundled format for a wide array of products, should be scrapped and replaced with an 11-year-old congressional mandate that aimed to boost summary reports.

FDA Safety Quality

QUOTED. March 16, 2018. Steven Peikin.

Check out what US Securities and Exchange Commission official Steven Peikin had to say about the implications of the agency’s recent charges and settlement with embattled testing company Theranos.

Quoted Enforcement

Malaysia Consults On Facilitating Exports By Original Equipment Manufacturers

The Malaysian medtech regulator has issued a new circular and a related draft guidance to facilitate the export of medical devices manufactured by original equipment manufacturers.

Malaysia Regulation

Tougher Sanctions And Penalties Kick In For Advertising Breaches In Australia

Australia has introduced new civil penalties and amended criminal offense provisions for breaches of its therapeutic product advertising rules. More reforms to the advertising regulations are expected soon.

Advertising, Marketing & Sales Policy & Regulation

Goodbye CFDA, Hello MRA: China Overhauls Regulatory Bodies

China proposes to merge its top drug and device regulator into a new combined body and create a medical reimbursement agency in moves directed at strengthening regulatory oversight.

Regulation Reimbursement

Medical Imaging Group COCIR Names New President

The EU association representing the medical imaging, radiotherapy, health IT and electromedical industries appoints a new president.

Europe Policy

No-Device 'Right-To-Try' Bill Fails To Pass House Muster

"Right-to-try" legislation aimed at giving severely ill patients access to drug treatments not yet approved by US FDA failed to win support from the needed super-majority in a Tuesday night vote in the US House. Before the vote, the bill's scope was narrowed by removing medical device provisions, and making it applicable only to those facing death within a matter of months. A Senate version still in play retains the device language.

Legislation Policy

Quality Control & Compliance Explore this Topic

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FDA Warning Letters For Olympus, Fujifilm, Pentax: Duodenoscope-Makers Fail To Meet Agency's Post-Market Surveillance Study Order

US FDA sent the letters to Olympus Corp., Fujifilm Medical Systems USA Inc. and Pentax Medical after the firms failed to meet obligations to conduct Sec. 522 post-market studies on their duodenoscopes, the use of which caused a number of antibiotic-resistant superbug infections in 2013 and 2014.

FDA Enforcement

Stakeholders To FDA: It's A Bad Idea To Ask For More Adverse Events In Quarterly Summary Reports

Stakeholders criticized the US agency's plan to gather more adverse events in a summarized fashion under its proposed Voluntary Malfunction Summary Reporting Program. Ten commenters pleaded with FDA to reconsider its plan, while one industry attorney questioned why the agency never adhered to a 2007 congressional mandate that it collect more summary reports.

FDA Safety

Medtronic Initiates Class I Recall For ICDs Due To Manufacturing Error

Medtronic is recalling certain ICDs and CRT-Ds due to a manufacturing defect that causes a gas mixture inside the device that could prevent the device from delivering necessary electrical shocks, US FDA announced Feb. 26.

Product Recalls Safety

Commercial Explore this Topic

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Theranos' Holmes, Balwani Slammed By SEC For 'Massive Fraud'

In another blow from the US government, securities regulators have severely penalized Theranos and its cofounder, Elizabeth Holmes, for allegedly lying to investors to raise funds.

Enforcement Legal Issues In Vitro Diagnostics

QUOTED. March 19, 2018. Michael Suk.

Check out what Geisinger orthopedic surgeon Michael Suk had to say about the organization’s new partnership with hip-device firm Medacta International.

Quoted Market Access

Abiomed Settles Kickback Allegation Tied To Pricey Meals

Heart-pump manufacturer Abiomed has agreed to pay $3.1m to resolve allegations the company violated the US False Claims Act by spending lavishly on physicians.

Legal Issues Commercial

Orthofix Moves In On Spinal Kinetics For $105m

Orthofix is investing in its spine business with the acquisition of cervical disc implant-maker Spinal Kinetics.

Orthopedics M & A

Geisinger And Medacta Pilot Guarantees Coverage Of Hip Replacements For Life

Geisinger Health has teamed up with Swiss-based device-maker Medacta International in a pilot program guaranteeing lifetime coverage of hip replacement costs for Geisenger patients.

Market Access Reimbursement

Siemens Healthineers Floats On Frankfurt Stock Exchange

Siemens Healthineers is a publicly listed company now that its shares debuted on the Frankfurt Stock Exchange on March 16.

Companies In Vitro Diagnostics

QUOTED. March 15, 2018. Pamela Spence.

Check out what Ernst & Young’s Pamela Spence had to say about the business threat to health-care firms from the tech world and how companies must respond.

Quoted Digital Health

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Stryker Pushes For Changes To Stroke Care After DAWN

Stryker's Trevo Retriever is the first stent retriever approved by US FDA as a front-line treatment for patients experiencing acute ischemic stroke up to 24 hours from symptom onset, matching the time window recommended in the latest professional treatment guidelines. Now, the company is trying to help the stroke-care system in the US catch up to the science.

Approvals Clinical Trials Innovation

Global Device Approvals, Weekly Snapshot: March 5-11, 2018

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

Approvals Innovation

Starts & Stops: March 5-11, 2018

Starts & Stops is a regular feature in Medtech Insight highlighting noteworthy clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers the trial announcements between Mar. 5-11, 2018, including clinical trial announcements from Mercator MedSystems, Boston Scientific and Brainsway Ltd.

Starts & Stops Clinical Trials

CRT 2018: Late-Breakers Feature Sapien MR, Selution DCB, Low-Risk TAVR, and Radial Access PCI

The late-breaking trials presented at the 2018 CRT Conference in Washington, DC, March 3-6 included new clinical data on novel drug-eluting coronary stents, endovascular peripheral vascular interventions, and transcatheter heart valve devices, plus a major trial comparing transfemoral and transradial coronary interventions.

Clinical Trials Innovation

AAOS Roundup: Robotic Ortho Surgery Continues To Gain Traction, Led By Stryker's MAKO

Stryker is enjoying strong demand for its MAKO robotic surgery platform with plans to increase system placements and procedure volumes while working on a next-gen system that would enhance ease-of-use for surgeons and improve accuracy. The company also has plans to expand into other areas of focus, according to analyst reports from this year's AAOS annual meeting in New Orleans. Meanwhile, Smith & Nephew and Zimmer Biomet are trying to set themselves apart with their robotic technologies.

Orthopedics Surgery

Starts & Stops: Feb. 26-March 4, 2018

Starts & Stops is a regular feature in Medtech Insight highlighting noteworthy clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition is the first weekly edition of Starts & Stops, including all the trial announcements between Feb. 26 and March 4, 2018, including announcements from Abbott Laboratories, Medtronic, Auris Surgical, Edwards Lifesciences and Epimed International.

Starts & Stops

Global Device Approvals: Weekly Snapshot

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

Approvals Innovation