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European Commission Answers Vital Questions In Second Major Brexit Response

European Commission issues Q&A document to help industry understand specifics of “placing” products on the EU market in the context of Brexit, and what needs to be done regarding responsible persons, importers and certificate transfers.

Brexit Regulation Market Access

Roche And IBM Predict Future Of Big Data In Diabetes Care

Real world data and machine learning could play an increasingly important role in decision-making processes in diabetes care according to new research by Roche and IBM. The two companies conducted a major study to predict diabetes-related kidney disease in patients with chronic disease.

Artificial Intelligence Diabetic Care Research & Development

ACLA Rejects FDA As A ‘Clinical Validity’ Judge, While AdvaMedDx Seeks Tweaks To VALID Act

Clinical labs are troubled by the idea of granting US FDA vast discretion to determine if laboratory-developed tests (LDTs) are analytically and clinically valid, a key feature of the draft US VALID Act, while in vitro diagnostic kit manufacturers want some clarifications and more flexibility written into the proposal for diagnostic regulatory reforms.

Legislation In Vitro Diagnostics Regulation

Thought-Controlled Prosthetics Get US FDA 'Leapfrog' Treatment

A new "leapfrog" draft guidance from the US agency addresses implanted brain-computer interface prosthetic devices, and, specifically, the information sponsors should be prepared to submit for pre-submissions meetings and investigational device exemptions.

Innovation Regulation Guidance Documents

Device Week, Feb. 22, 2019 – The Latest On Lab Reimbursement And Possible LDT Regulatory Reform

In this week’s podcast, senior reporter Sue Darcey talks about troubling developments for US laboratories and diagnostic test-makers that say the Government Accountability Office was mistaken in conclusions it reached in a recent report about how much labs will be billing Medicare for clinical tests. Also discussed are comments lab associations sent to US legislators, who have been trying to win industry and stakeholder consensus on a regulatory reform proposal for laboratory developed tests (LDTs) that they call the VALID Act.

Device Week Medicare Reimbursement

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Pulse Of The Industry 2018: How Medtechs Will Create Value In The New Health Ecosystem

In the 12th edition of EY’s medtech report, The Pulse of the Industry, they examine the annual performance of the medical device industry in the context of the technological advances and rising customer expectations associated with the Fourth Industrial Revolution. To thrive in this transformative age, medtechs must adapt their business models to meet the increased expectations of consumers and other health care stakeholders.

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Policy & Regulation Explore this Topic

Set Alert for Policy

Regenerative Medicine Therapies: Manufacturing Changes May Not Impact RMAT Designation

Final guidance notes that preliminary clinical evidence may come from studies conducted outside the US, says historical controls may be considered in clinical trial designs.

Regenerative Medicine Clinical Trials Manufacturing

Podcast: Legal Expert Advises On Patentable Subject Matter As Courts Send Conflicting Message

Three major cases have provided different interpretations of what is considered patentable subject matter, and to top it off a new guideline from the US Patent and Trademark Office has added to the confusion, according to a legal expert. Harness Dickey’s Chris Cauble walks us through what patent-seekers need to know and how to prepare their patent filings in this interview (podcast and transcript).

Intellectual Property Innovation Digital Health

Minor Updates To US FDA Guidances Aim To Clarify What PMA, 510(k) Applications Should Include

The agency has republished two guidance documents outlining conditions for when it could not accept a 510(k) or PMA application for review to incorporate regulatory updates. While the changes are minor, FDA hopes they will continue to give sponsors enough detail to reduce the number of applications that get turned away for lack of basic information.

Regulation Review Pathway

QUOTED. Feb. 22, 2019. Chris Cauble.

Legal experts say recent court cases and a new guideline from the US Patent and Trademark Office on patent-eligible subject matter have created a lot of ambiguity for companies. See patent advice from Harness Dickey attorney Chris Cauble here.

Quoted Intellectual Property

US FDA Now Requires GCP Statement For Foreign Trial Data

A regulation finalized last year kicks in today requiring companies to either include along with US FDA submissions a statement affirming Good Clinical Practice compliance for any data collected outside the US, or get a waiver.

Clinical Trials Regulation

QUOTED. Feb. 21, 2019. Damien McDonald.

Device-maker LivaNova will put its vagus nerve stimulation system to another sham-controlled test in patients with treatment-resistant depression by leveraging a newly finalized Medicare national coverage determination, which covers patients with bipolar disease. See what LivaNova CEO Damien McDonald said about it here.

Quoted Neurology

Spinal Implants: Finding A Manageable Regulatory Pathway Through Complex EU MDR Wording

Efforts are underway by EU notified body groups to encourage a uniform interpretation of the EU MDR when it comes to the risk classification of spinal implants. Their work could also reduce the amount of unnecessary notified body and expert panel work on some implantable devices.

Medical Device Europe

Warning Letter Roundup & Recap – Feb. 19, 2019

A Beverly Hills doctor was slapped with a US FDA warning letter for quality systems, Medical Device Reporting and pre-market issues related to a device used during breast augmentation procedures, and an Oyster Bay, NY, specification developer of the Better Bladder device was instructed by the agency to hire a consultant to help fix its quality systems issues. Two other missives were released this week – the first device-related warning letters posted online by FDA since early December 2018.

Device Warning Letters FDA

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Warning Letter Roundup & Recap – Feb. 19, 2019

A Beverly Hills doctor was slapped with a US FDA warning letter for quality systems, Medical Device Reporting and pre-market issues related to a device used during breast augmentation procedures, and an Oyster Bay, NY, specification developer of the Better Bladder device was instructed by the agency to hire a consultant to help fix its quality systems issues. Two other missives were released this week – the first device-related warning letters posted online by FDA since early December 2018.

Device Warning Letters FDA

FDA Draft Guidance Outlines Agency's Plan To Offer Nonbinding Feedback On Form-483 Observation Resolutions

Device manufacturers would be able to get nonbinding feedback on their plans for how to resolve some Form-483 inspectional observations from US FDA officials under a new draft guidance released Feb. 15.

Guidance Documents FDA

Medtech Tips: First-Rate Problem Statement Key To Failure Investigations, Cardinal Health Quality VP Says

A clear, succinct problem statement is the backbone of a winning device failure investigation, Karl Vahey says. He notes that a well-developed statement is also useful to have on hand when regulators conduct a facility audit and review corrective and preventive action (CAPA) activities.

Medtech Tips Quality

Commercial Explore this Topic

Set Alert for Commercial

Market Brief: Bone Densitometer And Bone Turnover Markers Will Reach $373.1M In 2023

The global market for bone densitometers and bone turnover markers will reach $373.1m by 2023, driven in large part by the rising aging population and rising prevalence of osteoporosis.

Commercial Market Intelligence Orthopedics

FDA Approves Biotronik’s Thin-Strut Orsiro Coronary Stent

Bioresorbable-polymer, sirolimus-eluting Orsiro outperformed Abbott’s market-leading Xience durable-polymer, everolimus-eluting stent at the two-year follow-up in the BIOFLOW V trial. The company stresses that Orsiro is the first and only ultrathin drug-eluting stent to beat Xience in a randomized trial.

United States Approvals

Nevro Files Patent Suit Against Stimwave

Chronic pain treatment company Nevro has filed suit against rival Stimwave Tech alleging patent infringement.

Legal Issues Intellectual Property

Execs On The Move: Sales Execs Switch Spine Firms; New Chiefs At VentureMed, Cassini

Three spine sales VPs left Amedica for Xtant Medical, which also hired two additional sales execs last week. Meanwhile, angioplasty device firm VentureMed Group hired a new CEO, and ophthalmic diagnostic firm Cassini Technologies promoted for its top spot from within.

Appointments Commercial

MDx Health Names New CEO

MDx Health has named a new CEO to lead its commercial growth following a disappointing set of results in 2018.

Appointments Commercial

Medtech Money Flow: M&A And VC Deals, Feb. 11-17, 2019

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Feb. 11 - 17, 2019.

M & A Deals

QUOTED. Feb. 15, 2019. Larry Biegelsen.

Johnson & Johnson announced it will acquire robotic startup Auris Health for $3.4bn in cash, plus up to $2.4bn in milestones. See what Wells Fargo analyst Larry Biegelsen wrote about it here.

Quoted Deals

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Results Recap: PRODIGY Supports Medtronic’s Opioid-Related Risk Predictor; Axionics' SNM System For Incontinence Succeeds

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering Feb. 11 through Feb. 21, includes published results from trials of Medtronic's respiratory compromise monitoring system, Agile's contraceptive patch, Affluent's EVAR device for AAA, Abbott's flash glucose monitor, and Axionic's anti-incontinence device.

Tracking Trials Research & Development Clinical Trials

Global Device Approvals, Weekly Snapshot: Tandem Diabetes Win

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, Tandem Diabetes Care gained US FDA go-ahead for the first "interoperable" insulin pump.

Approvals Research & Development

QUOTED. Feb. 19, 2019. Walton Taylor.

The American Society of Breast Surgeons published new guidelines, recommending that genetic testing should be offered to all patients with a history of breast cancer. See what the American Society of Breast Surgeons' president said about it here.

Quoted Cancer

Breast Surgeons Advise All Breast Cancer Patients Be Offered Genetic Testing

The American Society of Breast Surgeons published new guidelines, recommending that genetic testing should be made available to all patients with a history of breast cancer. The new recommendations are not in line with existing guidelines made by the National Comprehensive Cancer Network.

Cancer In Vitro Diagnostics

Device Week, Feb. 13, 2019 –  Femtech Draws Investment; Smith & Nephew/Nuvasive Merger Rumors Emerge

In this edition of Device Week, Medtech Insight’s Reed Miller talks to managing editor Marion Webb about the growing interest among investors in "femtech," technology that specifically addresses women's health issues that have been frequently overlooked in the past. And London-based reporter Catherine Longworth addresses the recent media reports that Smith & Nephew may make a bid for spine-device company Nuvasive.

Device Week Business Strategies

Global Device Approvals, Weekly Snapshot: Spine Device Duo

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, two spine device approvals from US FDA, and a CE mark for a new drug-eluting stent.

Approvals Research & Development

Results Recap: Personal KinetiGraph Provides Useful Information On Parkinson’s; Leviticus’ Wireless LVAD Power System Shows Promise In First Patients

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering Feb. 1 through Feb. 10, includes published results from trials of Global Kinetics’ Personal KinetiGraph movement recording system for Parkinson’s disease patients, Milestone Scientific’s CompuFlo Epidural System for epidural-block anesthesia, and Leviticus Cardio’s wireless Coplanar Energy Transfer system for left-ventricular assist devices.

Tracking Trials Research & Development
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