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FDA's Speedy Apple Watch De Novos Raise Questions For Industry

The recent US FDA de novo approvals for heart-rhythm analysis software on Apple's latest Apple Watch, which took about 30 days from submission to a decision that aligned with Apple's high-profile launch event, raised eyebrows in the medtech industry. Some in industry are concerned that the tech giant received preferential treatment over smaller companies, setting a bad precedent. But some say it could be a positive sign for the digital health industry at large.

Digital Health Regulation Medical Device

IVDR Notified Body Pulls Applications As The EU System Struggles To Cope

European Commission figures have already suggested IVD testing capacity could be woefully short of demand. Now one notified body applicant is dropping out. What are the implications?

Europe Regulation In Vitro Diagnostics

TCT 2018: Abbott Expects COAPT Results To Support Expanding MitraClip's Indication

Data presented at the Transcatheter Cardiovascular Therapeutics conference Sept. 23 in San Diego will support expanding the label of Abbott's MitraClip mitral valve repair device to include secondary, or functional, mitral regurgitation, a company executive tells Medtech Insight. In the COAPT trial, MitraClip reduced the two-year rate of heart-failure hospitalization and all-cause mortality in patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation.

Clinical Trials Innovation Research & Development

Market Intel: Innovation Drives Growth, Draws Younger Patients In Joint Replacement Implants Market

The worldwide joint-replacement implants market is expected to hit $20bn by 2022, according to a new report from Meddevicetracker. The growth is driven by the rising number of elderly patients, whose natural joints have been damaged by arthritis, and the rising prevalence of chronic diseases, such as obesity and diabetes, and sport-related injuries. But a look at the market and the three largest segments  shoulder, knee and hip replacements  show that new technological advancements and improved surgical techniques are increasingly making joint replacement surgeries an option for younger people as well. Here's an overview and key insights from two orthopedic surgeons on the current market and key growth drivers and limiters.

Orthopedics Surgical Procedures Market Intelligence

QUOTED. Sept. 25, 2018. Cisco Vicenty.

US FDA's Voluntary Medical Device Manufacturing and Product Quality Pilot Program has become so popular that both the agency and device-makers are sending their own employees to CMMI Institute to be trained as Appraisal Team Members to assist in appraisals at device firms. See what FDA's Cisco Vicenty said about it here.

Quoted FDA Manufacturing

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Getting The Words Right: Device Documentation And Translation in Asia

Oracle Health Sciences

Although the medical device sector has seen increasing harmonization of regulations both globally and regionally, market-entry requirements in Asia still retain a significant degree of localization, particularly as they relate to product labeling and documentation.

Download the article to learn more about the challenges and potential rewards of device documentation and translation in Asia.

The article reviews:

  • New regulatory reforms and their impact
  • The role and limitations of localizing software
  • Opportunities to translate for growth

Read Article

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Policy & Regulation Explore this Topic

Set Alert for Policy

FDA Guidance Looks At Benefit Vs. Risk In Certain 510(k)s

A newly finalized guidance document from US FDA explains how the agency will evaluate benefit and risk questions for substantially equivalent products with differing technological characteristics.

Medical Device Regulation In Vitro Diagnostics

Can EU Regulations Be Changed To Allow For More Time? MedTech Europe Says 'Yes'

Huge numbers of products risk failing to comply the new EU regulations in time. Are efforts to extend deadlines legally and practically possible and will they be supported? MedTech Europe's Oliver Bisazza talks with Medtech Insight.

Europe Regulation Medical Device

QUOTED. Sept. 24, 2018. Joe Grogan.

The Trump administration is prioritizing reforms to improve the reimbursement process for medical devices, and it is willing to spend money to do it. That's according to Joe Grogan, the health program associate director for the White House Office of Management and Budget. See what he said about it here.

Reimbursement Market Access

US Watchdog OKs Ortho Firm's Refund Plan

A device manufacturer wouldn’t violate anti-kickback law by offering hospitals a refund if their joint replacement fails for patients, the Department of Health & Human Services’ Office of the Inspector General said in a recent advisory opinion.

Compliance Policy

QUOTED. Sept. 21, 2018. Paula Cofer.

A patient advocacy group recently met with US FDA officials to ask for new safety measures, if not a total ban, around LASIK eye surgery. See what the group's coleader, Paula Cofer, said about the dangers of LASIK here.

Quoted Safety

FDA Finalizes Guidance On Products Containing Heparin

US FDA has issued a final guidance document discussing appropriate labeling for products containing heparin. The new rules reflect recent revisions to US Pharmacopeia monographs on heparin solutions.

Medical Device Surgical Procedures

'The Sky's The Limit' When It Comes To Device Reimbursement Reforms, White House Official Says

The top health official at the White House Office of Management and Budget says the Trump administration is committed to clearing barriers that stand in the way of reimbursement for new medical technology. “We’re doing a lot of work on medical device stuff that nobody knows about, trying to figure out how America can maintain our dominance," Joe Grogan said Sept. 20.

Reimbursement Market Access

Enforcing ClinicalTrials.Gov Reporting Requirements: FDA Issues Draft Guidance

A new US FDA draft guidance describes the agency's plans to identify trial sponsors that have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov. The draft guidance also clarifies when the agency will seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties and the civil money penalty amounts that may be assessed.

Clinical Trials Compliance

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Device Week, Sept. 21, 2018 – Medtech’s Next Top Maturity Model, Part 4

Medtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must clear to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework.

Device Week Quality Control

Assessing A Device-Maker's Manufacturing Capability Is Serious Business For These 2 Longtime CMMI Appraisers. Here’s Their Story

From training classes to onsite observations, two lead appraisers affiliated with Pittsburgh's CMMI Institute describe the high hurdles they jumped to be part of a flourishing US FDA pilot program that aims to elevate product, manufacturing and process quality at device firms. The pilot uses an industry-tailored version of the tried-and-true Capability Maturity Model Integration (CMMI) framework that's been around for decades. Beth Layman, an appraiser who has assessed more than a hundred companies in a variety of industries, says appraisers can't just be book-smart – rather, they must also possess a select set of personal skills, including flexibility and open-mindedness. Her fellow appraiser Thayne Hill, who "was there in the early days" of the Capability Maturity Model, says device-makers are often leery of appraisers because of past negative interactions with regulators, which can make his job challenging.

The fourth of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.

Quality Control FDA

FDA Staffers, Device Firm Employees Are Training As Appraisal Team Members For CMMI Maturity Model Pilot

US FDA's ongoing Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which assesses device-makers' manufacturing maturity and capability, has become so popular that both the agency and manufacturers are sending their own employees to CMMI Institute to be trained as Appraisal Team Members, or ATMs, to assist in device-related Capability Maturity Model Integration (CMMI) appraisals.

Quality Control FDA

Commercial Explore this Topic

Set Alert for Commercial

Execs On The Move: Change At Codiak Biosciences, And On Qualigen, Sectra AB Boards

A new executive VP and head of research and development is joining the management team at Codiak Biosciences. In addition, new directors joined at Qualigen and Sectra AB.

Appointments Commercial Medical Device

Execs On The Move: New Insulet CEO, And Financial Leadership Changes at Allurion, Lumicell and QuantuMDx

A trio of new chief financial officers were hired, at Allurion Technologies, Lumicell and QuantuMDx. Precision Therapeutics expanded its recently formed Scientific Advisory Board, and at Insulet Corp., there will be new leadership in the top spot come January.

Appointments Medical Device

TCT 2018: Next-Gen Stents, Key Insights From Leading Experts

The Transcatheter Cardiovascular Therapeutics meeting held in San Diego featured late-breaking trials of new stent technologiesincluding TALENT, BIONYX, BIOFLOW-V, SORT-OUT IX, LEADERS FREE II and ReCre8.

Commercial Clinical Trials

Medtech Money Flow: M&A And VC Deals, Sept. 17 - 23, 2018

Find out where the medtech money is flowing in our weekly roundup. Among other deals, Medtronic makes a mammoth acquisition to buy the remaining shares of Israeli surgical robotics firm Mazor Robotics and Israeli company MeMed secures $70m to advance its point-of-care immune system diagnostic for distinguishing between bacterial and viral infections.
M & A Deals

The Medtech Conference: Industry Is Falling Short In Digital Investments

Industry fundamentals to date suggest the device sector as a whole should be doing more to go all-in on digital and data analytics. That's the takeaway from EY's annual "Pulse of the Industry" report for the medtech space.

Digital Health Business Strategies

Medtronic Buys Mazor Robotics For $1.3Bn

Medtronic is straightening up as a market leader in spinal surgery after agreeing to buy the shares of Mazor Robotics that it does not already own. The $1.3bn deal builds on an existing agreement between the companies formed in May 2016 and strengthens Medtronic as the front runner in the spine robotics field.

M & A Israel

QUOTED. Sept. 20, 2018. Benita Pearson.

A lawsuit over negative pressure wound-therapy devices ended in a win for plaintiff KCI Medical Services after an Ohio federal judge ordered Healthcare Essentials Inc. to pay $645m for alleged theft. See what Judge Benita Pearson wrote about the case here.

Quoted Legal Issues

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Results Recap: Terumo PulseCath Shows Promise In High-Risk PCI; Reapplix' LeucoPatch Promotes Ulcer-Healing

Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition covers the week of Sept. 14-20, including trial announcements from Nanobiotix, Reapplix, Profound Medical, Sequana Medical, and Terumo.

Tracking Trials Clinical Trials Innovation

Global Device Approvals, Weekly Snapshot: Transcranial Stimulator For Alzheimer's, And More

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the five added this week, Neuronix's NeuroAD Non Invasive Cortical Enhancer technology was approved in Australia for use in Alzheimer's patients, in combination with "tailored cognitive therapy."

Approvals Research & Development

Starts & Stops: MedAutonomic Initiates Phoenix Neuromodulation Stomach Implant Trial; Boston Scientific Completes S-ICD Trial Enrollment

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Sept. 17 through Sept. 23, including trial announcements from Boston Scientific, MedAutonomic, Desiral, and Edwards Lifesciences.

Starts & Stops Tracking Trials

Enforcing ClinicalTrials.Gov Reporting Requirements: FDA Issues Draft Guidance

A new US FDA draft guidance describes the agency's plans to identify trial sponsors that have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov. The draft guidance also clarifies when the agency will seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties and the civil money penalty amounts that may be assessed.

Clinical Trials Compliance

Results Recap: Sept. 7-13, 2018

Results Recap is a new regular feature in Medtech Insight providing a summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition includes trial announcements from NeuroMetrix, Vertos, LivaNova, and Boston Scientific.

Tracking Trials Clinical Trials

NICE Endorses Sutureless Aortic Valves While LivaNova Reaches Study Milestone

A new guidance from the UK's National Institute for Health and Care Excellence (NICE) concludes that sutureless aortic valve replacement is an alternative to conventional surgical aortic valve replacement. The NICE guidance came as LivaNova announced completed enrollment in the 900-patient, randomized PERSIST-AVR trial of its Perceval sutureless aortic valv.

Clinical Trials Companies

QUOTED. Sept. 13, 2018. Deb Houry.

The US Centers for Disease Control and Prevention's new clinical recommendations for health-care providers treating children with concussions or mild traumatic brain injury (mTBI) advise physicians against using advanced imaging for diagnosis. See what the CDC's Deb Houry said about the guidelines here.

Quoted Research & Development
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