Medical device makers would do well to fortify their cybersecurity strategies in preparation for the extra layers of software testing and review in development at the FDA. Federal healthcare regulators have solicited bids from security group Codenomicon Defensics to help build a "cybersecurity laboratory" where regulators can take a closer look at software bugs and weaknesses in medtech systems.
In Part 1 of this blog, I described the background and approaches StarFish Medical employed for more modern devices with a comprehensive technical file, giving five top tips. In Part 2, I now describe how we recertified for older devices where the available design documentation was less comprehensive.
Medical device giant Edwards Lifesciences is powering forward with its solo-hold on the U.S. market for transcatheter aortic valve implantation systems, now preparing to launch an Investigational Device Exemption clinical trial of its next-generation Sapien 3 TAVI device.
Alere Connect has been granted a 510(k) market clearance by the U.S. FDA for the Alere MobileLink. The new product offering is one of Alere's connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems accessed by their healthcare providers.
Representatives in the U.S. House are set to top last year's vote to repeal the 2.3% medical device excise tax. The "Protect Medical Innovation Act of 2013," co-sponsored by Reps. Erik Paulsen (R-Minn.) and Ron Kind (D-Wis.), has garnered 259 signatures, according to the Library of Congress' THOMAS database.
In Part 1 of this blog, I’ll describe the background and approaches we at StarFish Medical took for more modern devices with a comprehensive technical file, with five top tips. In Part 2, I’ll describe how we recertified for older devices where the design documentation was less comprehensive, with seven top tips.
Ambio Health scored a green light from the FDA for its Ambio Remote Health Monitoring System, passing muster as a Class II device, the same category as wheelchairs and infusion pumps. The at-home monitoring system is designed to keep tabs on vital signs for patients with high blood pressure, heart disease and diabetes.
Biopharmaceutical and Medical Device Associations Strongly Support Senate Bill to Exempt FDA User Fees from SequestrationAugust 1, 2013 3:12 pm | by Business Wire | News | Comments
Today, Sen. Mark Pryor (D-AR), chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, and Sens. Roy Blunt (R-MO), Daniel Coats (R-IN), Al Franken (D-MN), and Jerry Moran (R-KS) introduced S. 1413 to exempt future Food and Drug Administration (FDA) user fees from sequestration.
This week, the U.S. Food and Drug Administration (FDA) announced the recall of GE Healthcare’s Nuclear Medicine Systems were recalled following an incident at a VA Medical Center in which a patient died due to injuries sustained while being scanned.
The FDA is looking to make some updates to its medical device benefit-risk calculations, taking into greater consideration the preferences of patients, caregivers and healthcare workers. The federal watchdog agency is holding a public workshop to solicit suggestions on how its medical device review arm might better assess and incorporate patient perspectives on "meaningful benefits" and "appropriate risks" of new medical devices.
IntelligentMDx (privately held) announced today that the U.S. Food and Drug Administration (FDA) has cleared its automated molecular diagnostic test that detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE).
Public Workshop - The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes, September 18-19, 2013July 29, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
The purpose of this workshop is to discuss ways to incorporate patient preferences on the benefit-risk trade-offs of medical devices into the full spectrum of the Center for Devices and Radiological Heath (CDRH) regulatory decision making. It also aims...
Reason for Recall: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals...
Panasonic said Friday it will sell its ultrasonic diagnostic equipment business to Konica Minolta Inc. in January 2014 as part of efforts to improve its financial base eroded by the firm's recent sluggish performance.
Innovative product development and technology consultancy firm Cambridge Consultants has collaborated with Clinigen Group to create a new way of identifying fresh market applications for drugs nearing the end of their product lifecycle.
Cepheid today announced it has received market authorization from the U.S. Food & Drug Administration (FDA) for its Xpert MTB/RIF test. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be down-classified and brought to market.
EnteroMedics Announces PMA Application for VBLOC Therapy in Obesity Accepted for Review and Filing by FDAJuly 25, 2013 4:03 pm | by The Associated Press | News | Comments
EnteroMedics Inc., the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the U.S. FDA has accepted for filing the Company's Premarket Approval application for approval of the Maestro® Rechargeable System's VBLOC® vagal blocking therapy as a treatment for obesity.
The FDA puts its highest-risk label on a recall of programmable infusion pumps made by Codman & Shurtleff Inc., a division of Johnson & Johnson subsidiary DePuy Orthopaedics. Codman's implanted MedStream pumps were recalled over a potential defect in a component that measures the contents of the pump reservoir.
Since June 2009, all drug listing submissions have been done electronically using Structured Product Labeling (SPL) files. Now, devices can be listed using SPL as well. While the FDA does not require that devices be listed using SPL, the ability to do is there, with benefits including providing product exposure on sites such as the National of Library of Medicine’s (NLM) DailyMed.
As a manufacturer, the UDI rule allows us to take more than 30 years of experience in the development of marking and imaging technologies to satisfy a critical need in a new market. In terms of assisting our customers in their efforts to become compliant, we now offer the MPX-90M impact printer.
The FDA UDI rule will standardize the way the medical device industry identifies its products, which is a foundational step toward utilizing companies who offer higher value, more complex solutions. Engaging these solutions is critical to helping manufacturers secure supply chains, deter counterfeiting, and ensure patients have access to safe medical devices.
In reference to the UDI rule, the FDA estimates more than 1,200 companies are in need of equipment or have already implemented direct part marking into production. Of the 1,200 companies, roughly 700 are medical implant manufacturers, while the remaining 500 produce multi-use devices, such as surgical instruments.
The following standard must be met for all medical products intended to be used in the home: IEC 60601-1-11, which is “Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.”
While regulators are understandably focused on compliance, industry needs to focus on quality. The terms are often used interchangeably, but there’s a big difference between quality and compliance. Think of quality as the processes, procedures, and culture that permeate an organization—enabling it to consistently develop and produce high-quality medical device products that will meet or exceed regulatory requirements.
Digital Angel Corporation, following its recent share exchange with VeriTeQ Acquisition Corporation, announced that VeriTeQ filed a provisional patent with the U.S. Patent and Trademark Office in September 2012 for a microchip that is able to withstand high temperatures in order to make it compatible with the sterilization processes involved in the manufacturing of implantable medical devices.