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EU Regulations: The Catastrophic Costs Of Failing To Be A Trailblazer

Whatever the hurdles to compliance with the new EU Medical Device and IVD Regulations, procrastination will cost firms dearly, says Peter Rose, of compliance consulting firm Maetrics. In an interview with Medtech Insight, he stresses the urgency of quick action and calculates the cost to companies that are late to to comply.

Europe Medical Device Policy & Regulation

Start-Up Spotlight: Payers, Pharma Clients Bank On Prognos' Artificial Intelligence To Predict Disease

New York-based health IT company Prognos recently secured $20.5m in Series C financing to build out its artificial intelligence capabilities, which it has applied to a giant diagnostic laboratory registry containing data from some 180 million patients. Given the shift to value-based health care and the high costs of treating chronic diseases, insurers might use information from this registry to predict the likelihood of disease and reach out to members to help head off illnesses. Pharma clients, in turn, can use the data to target physicians to help them deliver effective treatments.

Artificial Intelligence StartUps and SMEs Start-up Spotlight

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 the traditional way. It's one model for the digital-health sector in the current health-care environment.

Digital Health Market Access Reimbursement

J&J Offloads LifeScan To Private Equity Firm For $2.1bn

Platinum Equity plans to acquire J&J's LifeScan business, which makes OneTouch blood glucose monitoring products, by the end of the year. J&J has been exploring strategic options for its diabetes businesses for more than a year, as revenues from the sector have declined. In October, the company announced plans to stop making the Animas Vibe and OneTouch Ping insulin pumps, and transfer patients relying on those products to Medtronic.

Companies Deals M & A

QUOTED. March 21, 2018. Jason Bhan.

Start-up firm Prognos has a lofty long-term mission: to use artificial intelligence and other smart technologies to eradicate disease. Check out what company cofounder Jason Bhan had to say about Prognos' use of AI here.

Quoted Artificial Intelligence StartUps and SMEs

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Recent Tweets from Medtech Insight

Policy & Regulation Explore this Topic

Set Alert for Policy

Warning Letter Roundup & Recap – March 20, 2018

In the only device-related warning letter released by US FDA this week, a specification developer of orthopedic implants was cited for quality systems violations.

Device Warning Letters FDA Enforcement

Saudi FDA Consults On Regulating Device Software, Distribution Requirements

Saudi Arabia has proposed adopting IMDRF guidelines on the regulation of medical device software. It has also issued a separate proposal to help medical device establishments comply with national regulatory requirements on the storage, handling and distribution of medtech products.

Policy & Regulation Safety Saudi Arabia

Influential Medtech Group Hires New Chief

The Medical Device Innovation Consortium, a public-private partnership that has been instrumental in pushing some important US FDA policy shifts, has picked Pamela Goldberg as its new chief. The tech innovation consultant has worked for a similar group on the state level to advance medtech in Massachusetts.

Appointments Regulation

Health Canada Changes The Rules For Device Disinfectants And Sterilants

Manufacturers of already-authorized medical device disinfectants and sterilants have 18 months to meet Health Canada’s new reclassification rule for such products.

Policy & Regulation Review Pathway

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

The US Centers for Medicare and Medicaid Services said on March 16 that 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

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

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

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

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

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

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

Commercial Explore this Topic

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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 Deals

Medtech Money Flow, Weekly M&A And VC Deals, March 12-18, 2018

In this weekly feature, Medtech Insight presents a roundup of the previous week's M&A deals and venture financing rounds recorded in our M&A and VC Deal Trackers. This edition presents the transactions announced March 12-18, 2018.

Commercial Companies

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

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

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

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

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Global Device Approvals, Weekly Snapshot: March 12-18, 2018

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

Approvals Innovation Research & Development

QUOTED. March 20, 2018. Raul Nogueira.

Check out what Raul Nogueira, the principal investigator of the DAWN acute stroke clinical trial, had to say about the new paradigm for treating strokes that should result from the study data, which device-maker Stryker is getting out ahead of.

Quoted Approvals

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

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

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