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French Supreme Court Finalizes PIP Fraud Rulings And Executive Sentencings

Medtech notified body TÜV Rheinland has been recognized as a victim of large-scale fraud in a final-instance ruling in the French criminal case that has led to the conviction and sentencing of the executives at the center of the EU PIP breast implant scandal.

Legal Issues Europe Safety

MIACH Orthopedics Score NFLPA Investment For ACL Repair Tech

MIACH Orthopedics, has secured $22.5m from investors including the NFL Players Association to continue US clinical trials for its Bridge-Enhanced ACL Repair (BEAR) technology.

Financing Orthopedics Commercial

FDA Disputes Study On Breast Implant Safety

US FDA has taken the rare step of publicly disputing a study that seemed to show elevated risks of long-term adverse events associated with silicone breast implants.

Safety Medical Device Surgical Procedures

Market Intel: Robotic Pills And The Future Of Painless Drug Delivery

Robotic pill technology, which is already being used for diagnostic purposes, will likely be embraced for the oral delivery of biologic drugs as well. Biologic therapies currently require injections in most cases, but some are exploring specialized robotic pills as a pain-free approach that could increase convenience and compliance, and thus efficacy, of medicines. Several established companies and research centers are working on both diagnostic and biologic therapeutic applications of pill-based technologies.

Gastrointestinal Diagnostics Commercial

QUOTED. Sept. 19, 2018. Martha Murray.

An anterior cruciate ligament (ACL) repair technology developed by MIACH Orthopedics has secured backing from investors, including the union for National Football League players, in a new round of financing. See what MIACH founder Martha Murray said about it here.

Quoted Financing Commercial

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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

Warning Letter Roundup & Recap – Sept. 18, 2018

The maker of wound-dressing product Omiderm was cited for quality systems violations in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA Enforcement

House-Passed Tax Bill Would Support Medtech Innovation, Lobbyists Say

The device industry is praising passage of “The American Innovation Act” by the US House. The bill is intended to promote new business start-ups – including fledgling medtech companies – by allowing certain tax deductions for net-operating losses.

Legislation Policy Medical Device

QUOTED. Sept. 18, 2018. Scott Gottlieb.

FDA Commissioner Scott Gottlieb envisions a day when only 10% of new diagnostics will have to undergo pre-market review by the US agency to reach market. See what he said about it here.

Quoted In Vitro Diagnostics

QUOTED. Sept. 17, 2018. Kevin Coy.

Many legal threats faced by device and diagnostics companies come from federal law and regulations, but a growing class of strict state privacy laws protecting consumer data could open the door to new risks. See what attorney Kevin Coy said about it here.

Quoted Legal Issues

Patient Group Pushes FDA For LASIK Ban

A group of patient advocates including one former US FDA official met with agency staff on Sept. 13 to raise awareness about adverse events tied to LASIK surgery. The group said the vision-correcting procedure is too risky to be offered as elective surgery.

Safety Regulation

FDA Looks To Whittle Down Dx Review Load With Pre-Certs, Third-Party Assists

US FDA Commissioner Scott Gottlieb and the agency’s new diagnostics office chief Tim Stenzel want to use a combination of pre-certification, assistance from third-party reviewers and review exemptions to help quickly clear the tsunami of molecular-based diagnostic tests expected to be submitted to FDA for review in the next several years.

In Vitro Diagnostics Regulation

Brexit: UK Promises Medtech Brexit 'No-Deal Consultation' As UK Teeters On Cliff Edge

The UK's MHRA is promising a consultation process to seek feedback on how medtech would be impacted by a no-deal Brexit; industry is currently left with many unanswered questions and a lack of informed, expert speculation.

Brexit Medical Device

Health Canada Consults On Changes To List Of Recognized Medtech Standards

Canada has proposed 15 new additions and other changes to its list of recognized medtech standards. By demonstrating conformity with the recognized standards, device-makers can satisfy the safety and effectiveness requirements of the Canadian medical device regulations.

Canada Safety

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Medtronic Slapped With 2 FDA Warning Letters For Problems At Minnesota, Puerto Rico Sites

Two Medtronic facilities that make cardiac rhythm management devices were sent warning letters by US FDA because of quality systems issues. The sites were inspected by the agency after the firm initiated high-risk class I recalls for an array of CRM products earlier this year.

FDA Enforcement

Zimmer Warning Letter Confirms Ongoing Issues With CAPA, Process Validation

US FDA has released a six-violation warning letter sent to a Zimmer Biomet facility in Warsaw, Ind. The company had already acknowledged that the letter was a possibility.

Compliance Enforcement

TrialScope Anticipates FDA Will Begin Inspecting Companies For Trial-Reporting Compliance

US FDA will soon ramp-up enforcement of the clinical trial transparency provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007, according to TrialScope Chief Strategy Officer Thomas Wicks. Those that fall foul of these new requirements will face penalties  and it looks like SMEs will be hardest hit.

Clinical Trials Regulation

Commercial Explore this Topic

Set Alert for Commercial

Medtech Money Flow: M&A And VC Deals, Sept. 10-16, 2018

Where is the money flowing in medtech? Find out in this edition of Medtech Money Flow, which rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, between Sept. 10-16, 2018.

M & A Deals Financing

KCI Awarded $645M In Stolen Device Case

An Ohio federal judge recently awarded $645m to Acelity subsidiary KCI, Inc. The company had sued Healthcare Essentials Inc. for allegedly stealing wound therapy units for resale.
Legal Issues Commercial

Israeli Robotics System Steers Closer To European Market

XACT Robotics has secured a CE mark for its XACT image-guided robotic needle steering system for CT-guided percutaneous procedures in the abdomen. The company is hoping to formally launch XACT by 2019 while expanding the system to additional clinical indications, including spine, and lung procedures.

Approvals Commercial

QUOTED. Sept. 14, 2018. Mir Imran.

Prominent medtech inventor and entrepreneur Mir Imran is laser-focused on robotic pill technologies. Check out what Imran said about a "smart" pill being developed by Rani Therapeutics that can deliver biologics orally.

Quoted Commercial

Device Week, Sept. 13, 2018 – A Big Week For LivaNova; Creavo Seeks Cardiac Test Breakthrough

In this edition of the Device Week podcast, Medtech Insight’s Reed Miller talks about the latest good news for LivaNova and Catherine Longworth provides an update on Creavo Medical, a UK-based company using an old technology for a new kind of cardiac test that could save hospitals money.

Device Week Cost Effectiveness

Stryker Takes A Shine To Photonics Firm Invuity

Just weeks after inking a billion-dollar acquisition of K2M, Stryker has announced a $190m deal to acquire photonics firm Invuity. Under the terms of the agreement, a subsidiary of Stryker will purchase all outstanding shares of Invuity for $7.40 per share in cash.

M & A Deals

Execs On The Move: Departures At KCI, Carl Zeiss Meditec And Synaptic Medical

A roundup of new exits and entries, with execs in clinical moving from Carl Zeiss Meditech to Topcon Medical Systems, in acute care from KCI to TransEnterix, and in operations, moving from Synaptic Medical to Second Sight Medical Products.

Appointments Commercial

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Starts & Stops: Sept. 10-16, 2018

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Sept. 10 through Sept. 16, including trial announcements from Medtronic, NovoCure, Gore, LivaNova, and BioSig.

Starts & Stops Tracking Trials Cardiovascular

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

Turkey’s Top Defense Company Sets Sights On Medical Technology

Aselsan, Turkey's leading defense company, is increasing its focus on medical technology to support localization of medical devices. The company has started projects to develop and produce mobile X-ray and MRI systems, as well as defibrillators.

Turkey Diagnostic Imaging

US Agency Advises Against Use Of Advanced Imaging To Diagnose Kids’ Mild Traumatic Brain Injury

The US Centers for Disease Control and Prevention (CDC) has issued a guidance on diagnosing and treating pediatric mild traumatic brain injury, that advises health care providers to avoid use of computed tomography, MRI, single photo-emission CTs, and skull radiographs in diagnosing kids 18 years and younger.

Diagnostic Imaging Neurology

Global Device Approvals, Weekly Snapshot: Sept. 3-9, 2018

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, five approvals were added from Europe, Israel and Japan.

Approvals Innovation
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