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Exec Chat: Medtronic Diabetes VP Talks Value-Based Health Care

Medtronic Diabetes exec Suzanne Winter talks with Medtech Insight about her business' approach to value-based health care, including recently inked agreements with insurers such as Aetna and United Healthcare.

Market Access Reimbursement Commercial

Ready, Set, GO! From Device Recalls To FDA Inspectional Changes, QA/RA Experts Must Leap Hurdles In 2018

Device-makers could be in for a change to how they handle product recalls now that US FDA is reevaluating its processes for market withdrawals. That's according to longtime device industry expert Steve Niedelman, who also points out other hot topics that quality and regulatory professionals need to keep a sharp eye on this year – such as the device center's "Total Product Life Cycle" approach and next moves in its "program alignment" inspection scheme – in this Medtech Insight podcast.

Quality Control Compliance FDA

Global Approvals Analysis: Emerging Markets Drive Volume Of OUS Approvals

The numbers of medical device approvals were up in most regions outside the US and the biggest surge, by percentage, was in approvals from emerging markets and the so-called BRIC countries. It remains to be seen if the trend will continue in 2018, but many companies are already counting on important non-US approvals coming in the next year.

Approvals Innovation Research & Development

QUOTED. Jan. 19, 2018. Ricki Chase.

Check out what consultant (and former FDAer) Ricki Chase had to say about why it's important for device manufacturers to keep tabs on their suppliers of components and services.
Quoted Compliance Quality

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Policy & Regulation Explore this Topic

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Podcast Exclusive: Jeff Shuren Discusses FDA's Device Strategic Priorities

In an exclusive sit-down with Medtech Insight, CDRH Director Jeff Shuren talked about his priorities for his center over the next three years and how they could impact the medical device industry. The overall aim is to boost the number of novel medical devices that reach the US market first.

Regulation FDA Policy

Commission Spells Out Non-Recognition Of UK Organizations In Future EU

While the details of UK's Brexit deal are not finalized, those paralyzed in disbelief at the enormity of the fallout will have to act. The European Commission spells out the upheaval necessary for medtech to realign into the EU-27.

Brexit Europe Medical Device

'Qui Tam' Suit Says Hospira Billed Government For Faulty Infusion Pumps

A newly unsealed whistleblower suit filed in Illinois federal court in 2016 alleges the company failed to alert US FDA or customers to software and power cable issues that could have harmed patients and users. Pfizer, which purchased Hospira in 2015 and sold the infusion pump unit in 2017, says the case has no merit, and the government has declined to intervene.

Legal Issues Quality Control

US House Votes To Delay Device Tax For Two Years As Part Of Budget Deal

The US House of Representatives agreed Jan.18 to delay implementation of the medical device excise tax for another two years, until January 2020. The delay is part of a continuing resolution to fund the government until Feb. 16, and support the Children's Health Insurance Program for six more years. Industry groups are jubilant at the tax reprieve, but the budget plan also needs Senate approval.

Policy Legislation

The Place To Be At FDA In 2018? Office Of Product Evaluation and Quality

US FDA's device center is making good headway toward informally launching its new total product lifecycle "super office" as soon as possible this year and making the reorganization official by the end of 2018, CDRH Director Jeff Shuren said in an interview.

Regulation FDA

Appealing An FDA Device Decision? Proposed Rule Clarifies Framework

US FDA has issued a proposed rule that explains what decisions are eligible for supervisory review, and sets a timeframe for filing appeals.

Medical Device Regulation

HHS Secretary Nominee Azar Advances In Senate

US HHS Secretary Nominee Alex Azar was approved by the Senate Finance Committee on Jan. 17, sending his nomination to the full Senate for consideration. The former pharmaceutical company executive supports approval of additional telehealth reimbursements and, at a recent confirmation hearing, he discussed more access to durable medical equipment for patients in competitive bidding program areas.

Policy Leadership

QUOTED. Jan. 18, 2017. Jeff Shuren.

Check out what FDA device director Jeff Shuren had to say about his center's path to simplicity, one part of CDRH's three-year strategic priorities.
Quoted Regulation

Quality Control & Compliance Explore this Topic

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'Qui Tam' Suit Says Hospira Billed Government For Faulty Infusion Pumps

A newly unsealed whistleblower suit filed in Illinois federal court in 2016 alleges the company failed to alert US FDA or customers to software and power cable issues that could have harmed patients and users. Pfizer, which purchased Hospira in 2015 and sold the infusion pump unit in 2017, says the case has no merit, and the government has declined to intervene.

Legal Issues Quality Control

BD Handed US FDA Warning Letter In Lead-Test Investigation

The agency letter cites quality systems, Medical Device Reporting and device clearance concerns. It stems from an ongoing investigation into lead tests distributed by Magellan Biosciences that sometimes give faulty results.

Quality Control Regulation

Compliance Corner: Suppliers Can Wreak Havoc On Process Validation Outcomes. Here Are 4 Ways To Keep Them In Check

Having a stellar supplier qualification program in place can lessen the variability in a device-maker's validated processes, says industry expert (and former FDAer) Ricki Chase. She notes that using tools such as questionnaires and onsite audits to determine the suitability of vendors, as well as requalifying and monitoring suppliers of components and services, is essential. "Suppliers can affect your validation activities. Suppliers can completely destroy everything you've put a lot of hard work into," Chase says.

Compliance Quality Control

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Start-Up Spotlight: OCON Medical Bets On A New 3D Copper Contraceptive Device

Israeli start-up OCON Medical is blazing a trail in the field of women's health with a new hormone-free contraceptive device. The company's IUB – intrauterine ball consists of copper pearls that prevent pregnancy locally within the uterus for five years.

Start-up Spotlight Commercial Companies

20-Plus Device-Related Episodes-Of-Care Included In New Medicare Bundled-Pay Models

The US Centers for Medicare and Medicaid Services' Innovation Center has launched a new voluntary bundled-payment model covering more than 20 different types of clinical episodes involving devices. But they will limit outcome evaluations to 90 days, which may not be long enough to demonstrate the value of some cardiac care and orthopedic devices.

Market Access Cardiology

CVR Partners With Chinese Investor To Take Stroke Screening Tech East

CVR Medical is looking to take its technology for screening carotid arterial health to China after signing a letter of intent with Chinese private equity firm Guangzhou LangRun to set up a joint venture dedicated to commercializing the Canadian company's product in that market.

China Neurology

US FDA Fights Persisting IV Supply Shortages From Hurricane Maria

The September hurricane destroyed Puerto Rican medical device plants, causing a shortage of several key products that's still being felt. FDA Commissioner Scott Gottlieb said Monday that the agency is allowing more imports and considering other tactics to ease the shortage.

Medical Device Puerto Rico

QUOTED. Jan. 17, 2018. Ariel Weinstein.

Check out what OCON Medical CEO Ariel Weinstein had to say about his company's efforts to leverage its "intrauterine ball" hormone-free contraceptive platform for future pipeline projects.
Quoted Commercial

Medtech Money Flow: Weekly M&A And VC Deals, Jan, 8-14

In this new 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 between Jan. 8-14, 2018.

M & A Financing

Lingering Debt And New E-Procurement System Await Turkish Medtech

2017 saw developments that were beneficial to the Turkish medtech industry, like the continued progress of the billion-dollar City Hospitals project, but also initiatives such as forthcoming Online Health System Market that will have a mixed impact on industry players. Additionally, the year also saw medtech suppliers increasingly frustrated by the growing debt that is owed to them by Turkey's hospitals, an issue that remains unresolved. This article give an overview of the Turkish medtech market in 2017 and developments to look out for this year.

Turkey Market Access

Clinical R&D Explore this Topic

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US Approvals Analysis: Hits Just Keep On Coming. Can It Last?

2017 was another record year for novel device approvals in the US, with typical large numbers of cardiovascular and IVD go-aheads, along with notable successes in neurology, with noninvasive stimulation and digital-app solutions seeing success. There was also an increase in 510(k) clearances last year. Here's a look at some key FDA approvals and clearance trends from the past year, including in infographic form.

Approvals Research & Development Innovation

Starts & Stops: 2017 Finishes With Progress For Edwards, Stalled Trials For Boston Scientific

Starts & Stops is a regular feature highlighting Medtech Insight's monthly picks of noteworthy clinical trial announcements, initiations, completions, and suspensions. The list for December is headlined by announcements on Edwards' transcatheter valve technologies. Meanwhile, MValve, a company Boston Scientific has invested in, is not going forward with a planned trial of its MValve dock device with Boston Scientific's Lotus valve, which is currently off the market.

Clinical Trials Starts & Stops

QUOTED. Jan. 16, 2018. Kelly Londy.

Check out what Lumicell CEO Kelly Londy had to say about why the device-maker is developing its LUM system to treat prostate, colorectal, esophageal and pancreatic cancers.
Quoted Clinical Trials

STAT-Dx Seals CE-IVD Mark For POC Syndromic Testing System

STAT-Dx has sealed a CE-IVD mark for its point-of-care syndromic testing system and a respiratory panel. The firm will launch the system in Europe in the second half of 2018.

Gastrointestinal In Vitro Diagnostics

Swedish Tinnitus Patch Rings In Positive Placebo-Controlled Data

Swedish company Sensori received a ringing endorsement from results of a clinical placebo study evaluating the use of its Antinitus patch to treat tinnitus. Results from the study were published in the scientific journal The International Tinnitus Journal.

Ear Innovation

JPM2018: Nevro Announces FDA Nod For Next-Gen Senza II Device

Redwood City, Calif.-based device-maker Nevro Corp. kicked off the annual J.P. Morgan Healthcare Conference in San Francisco on Jan. 8 with the announcement it received US FDA approval for its next-generation Senza II spinal cord stimulation system and better-than-expected Q4 earnings results.

FDA Approvals

Analytics 4 Life Aims For Q2 510(k) Submission For Heart Dx Device

Analytics 4 Life is developing the CorVista system, which can diagnose heart disease by analyzing data with a synchronous array of noninvasive sensors. The technology, based on cutting-edge phase-space tomography and cloud-computing, will be a relatively inexpensive alternative to nuclear stress testing or CT angiography.

Cardiology Diagnostics