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US Senate Approves US-Mexico-Canada Agreement Championed By Industry

The US Senate overwhelmingly approved a bill on 16 January to implement the US-Mexico-Canada agreement, which includes a new chapter on the handling of medical devices supported by the medtech industry.

Policy Trade Legislation

‘Immediately Discontinue’ Using Potentially Nonsterile Surgical Gowns, Packs From Cardinal Health, FDA Warns; Company Assessing Quality Issues

The US agency is telling health-care providers to yank specific gowns – and procedural packs that contain the gowns – from shelves because their maker, Cardinal Health Inc., cannot assure their sterility. The agency is also warning that the problem could lead to a shortage of so-called Level 3 gowns, which are used in a wide-array of everyday surgical procedures.

Recalls Quality Safety

Petition Argues FDA Has Overstepped In PGx Regulation

A group of manufacturers and clinicians is asking the US agency to allow more discussion between manufacturers, labs and clinicians of how genetic factors could influence drug effectiveness  an area known as pharmacogenomics (PGx). The FDA had previously taken several steps to limit these communications.

Diagnostics Regulation Medical Device

EU Nomenclature Mapping Project News: Will Critical Progress Be Hampered By Tensions?

It seems to be game over for anyone who might have been hoping the European Commission would do a U-turn on its decision to use the Italian CND nomenclature as the basis for communication in Eudamed, instead of the well-established GMDN. But GMDN is strong in its resolve to remain a vital global nomenclature service.

Medical Device In Vitro Diagnostics Europe

Device Week, 17 January 2020 – FDA's Amy Abernethy Describes Medtech's Future; Researchers Want More Oversight Of Robotic Surgery

In this edition of Device Week, Medtech Insight's Marion Webb discusses her experiences at the recent Consumer Electronics Show in Las Vegas, including her interview with Amy Abernethy, who is the US Food and Drug Administration's principal deputy commissioner. Deputy editor Reed Miller discusses a recent study from the University of Michigan that suggests the growth of robotic-assisted surgery may be outpacing the evidence to support that technology.

Device Week Exec Chat FDA

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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Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found.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 & Regulation

US Research Agency AHRQ Puts Out Call For Non-Pharma-Based Pain-Control Device Studies

The Agency for Healthcare Research and Quality (AHRQ) is conducting a review on treatments for acute pain and is asking device manufacturers and other organizations to supply it with studies on nonpharmacological therapies to control pain, including transcutaneous electrical nerve stimulation, ultrasound, heat- and cold-producing devices, and acupuncture.

Policy Comparative Effectiveness Clinical Trials

Essure Update: Almost All Unsold Units Back To Bayer; Postmarket Study Enrollment Complete

The US FDA says Bayer has successfully recovered unsold Essure units and completed enrollment in a Sec. 522 postmarket study, fulfilling deadlines set at a year from the date the devices were taken off the US market.

Post Market Regulation & Studies Regulation Gynecology & Urology

QUOTED. 16 January 2020. Amy Abernethy.

Medtech Insight sat down with US FDA's principal deputy commissioner Amy Abernethy at the recent CES meeting in Las Vegas to talk about the agency's progress on the Technology Modernization Action Plan (TMAP), the pre-certification program for digital health products, and the FDA's plans for 2020. The FDA will hold a public meeting on 27 March to discuss the TMAP. See what FDA's Abernethy said about it here.

Quoted Exec Chat

Exec Chat: CES 2020: For FDA's Amy Abernethy, It's About Data, But Also Community Engagement

Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.

Exec Chat FDA

Powered Wheeled Stretchers Now 510(k)-Exempt

Manufacturers won’t need to submit 510(k)s for powered wheeled stretchers under a new order from the US FDA.

Review Pathway Regulation

Former Palliative-Care Firm CEO Brad Smith Appointed Head Of CMS Innovation Center

Brad Smith, the former CEO of Aspire Health, a home-based palliative-care company, was appointed director of the Center for Medicare and Medicaid Innovation (CMMI) at the US Medicare agency CMS.

Policy Appointments

Warning Letter Roundup & Recap – 14 January 2020

No device-related warning letters were released by the US FDA the week of 14 January.

Device Warning Letters FDA

Medtronic Wins In England’s NICE Decision On Implantable Monitors For Stroke Patients; Biotronik And Abbott Lose

UK health technology assessment body NICE says that Medtronic’s Reveal LINQ, which transmits data remotely to doctors, is likely to be a cost-effective use of National Health Service resources.

Health Technology Assessment United Kingdom

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 4)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this fourth installment of a 10-part series, the experts address so-called back rooms used by manufacturers during an inspection.

Compliance Corner FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 3)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this third installment of a 10-part series, the experts address the do’s and don’ts of responding to investigator requests for information and records.

Compliance Corner FDA

Q3 Recalls Snapshot: Number Of Recalls Ticks Up For Third Consecutive Quarter; Recalled Units Spike An Incredible 1013%

Device makers initiated 243 recalls in the third quarter of 2019 – a modest 1% increase over Q2’s 200 recalls. Interestingly, the number of recalled device units skyrocketed a whopping 1013%, from 19.7 million in Q2 to 219.2 million in Q3. Check out our Q3 recalls infographic.

Recalls FDA

Commercial Explore this Topic

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Steady Health Launches Digital Diabetes Clinic

San Francisco-based start-up Steady Health is launching the first virtual full-service endocrinology clinic in California.

Digital Health Diabetic Care In Vitro Diagnostics

Quanta Dialysis Partners With B. Braun To Support Home Hemodialysis Care

Quanta Dialysis has signed an agreement with B. Braun to provide support services to Quanta’s patients in the UK. The hemodialysis firm launched its compact hemodialysis device SC+ on the market at the beginning of the year.

Renal Commercial

Execs On The Move: An Eli Lilly President Departs; Finance Positions Filled At NuVasive And DBV Technologies

The president of Eli Lilly USA departs for CEO post at FibroGen, a developer of medicines for anemia, fibrotic disease and cancer; a former Mallinckrodt exec is CFO of NuVasive, a maker of products for spine surgery; DBV Technologies, an investigator of treatments for food allergies, also adds a CFO; and more.

Commercial Appointments

Roche And Illumina Sign 15-Year Partnership To Advance NGS Testing

Roche and Illumina have entered a 15-year, non-exclusive partnership to expand access to next-generation sequencing- based testing in cancer care.

Cancer Diagnostics

QUOTED. 14 January 2020. Marshall Stanton.

Medtronic said it will acquire Stimgenics, which developed a differential target multiplexed spinal cord stimulation waveform, for an undisclosed figure. See what Marshall Stanton, who heads up Medtronic's pain therapy business, said about it here.

Quoted M & A

Start-Up Spotlight: BioVentrix Expects Revivent TC Heart Failure Device To Succeed Where Others Failed

Two-year data from a European trial showed BioVentrix’s Revivent TC system significantly reduces left-ventricular volume and improves left-ventricular function in patients with heart failure following a myocardial infarction. The company expects to complete a US pivotal trial of the device in 2021 and launch the device in the US with funding from a planned initial public offering.

Start-up Spotlight Innovation

Medtronic Adds Stimgenics’ Novel Pain Therapy To Intellis Spinal Cord Stimulator

Medtronic acquired Stimgenics, an Illinois company it previously helped to fund, for an undisclosed sum. The company plans to add Stimgenics’ differential target multiplexed spinal cord stimulation waveform to its Intellis spinal cord stimulation system for the treatment of chronic pain.

M & A Neurology

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Study Shows Rapid Adoption Of Robotic Assistance For Unproven Procedures

The authors of a large cohort study of the uptake of robotic-assisted surgery in Michigan hospitals argue that the rapid adoption of robotic techniques is not supported by existing clinical evidence.

Clinical Trials Research & Development Safety

QUOTED. 17 January 2020. Kyle Sheetz.

The rapid adoption of robotic-assisted surgery must be carefully monitored to ensure surgeons' enthusiasm for this technology does not compromise patient safety, according to a new study. See what Kyle Sheetz, a researcher at the University of Michigan who analyzed data from the Michigan Surgical Quality Collaborative, a partnership between Michigan hospitals and Blue Cross/Blue Shield of Michigan, said about it here.

Quoted Research & Development

QUOTED. 8 January 2020. Lucien Goffart.

French company Robocath expects its R-One robotic-assistance platform to make interventional cardiology more efficient and safer for interventionalists. See what company CEO Lucien Goffart said about “momentum in vascular robots” here.

Quoted Clinical Trials

December 2019 Approvals Snapshot: Abbott Earns New Approval For CentriMag Circulatory Support System

December’s new medical device approvals include the FDA approval of Abbott Laboratories’ CentriMag circulatory support system for postcardiotomy patients, MicroVention’s FRED system for wide-necked intracranial aneurysms and an expanded indication for Foundation Medicine’s FoundationOne CDx cancer-drug companion diagnostic.

Approvals Innovation

Robocath Updates Progress With R-One Robotic Coronary Intervention Platform

French company Robocath believes its R-One robotic catheter intervention system will make coronary interventions more efficient for hospitals and safer for interventionalists. Robocath is sponsoring a 60-patient European trial of coronary interventions with R-One.

Clinical Trials Innovation

Final Follow-Up Data Support Boston Scientific’s Watchman Stroke-Prevention Device

The final follow-up data from the CAP and CAP2 registries support left-atrial appendage closure with Watchman as an alternative to long-term anticoagulation in patients with nonvalvular atrial fibrillation.

Clinical Trials Research & Development

Start-Up Spotlight: Sight Diagnostics’ Imaging Technology Allows Accurate Diagnostics With Small Blood Samples

The US FDA recently cleared Sight’s Olo analyzer to run complete blood counts on samples as small as two drops. The company is currently marketing Olo to hospital labs in the US but hopes to eventually earn a CLIA waiver so Olo can be marketed to smaller physician practices and pharmacies and used for other common blood-based diagnostics.

Start-up Spotlight In Vitro Diagnostics