Devices
Medtronic says it is partnering with Fitbit to integrate health and activity tracking for patients with diabetes and their doctors and care teams. The companies say they are working on a mobile app to allow patients with Type 2 diabetes to see their glucose levels and physical activity data in
Devices
FDA has granted Voluntis 510(k) clearance for Insulia, a digital solution intended to support the effective management of Type 2 adult diabetes patients treated with basal insulin. According to the company, the prescription-only medical device provides patients with insulin dose recommendations and educational coaching messages in response to
Devices
In a paper prepared for the Annual Computer Security Applications Conference, researchers say there are “serious protocol and implementation weaknesses on widely used implantable cardioverter defibrillators (ICDs) which lead to several active and passive software and radio-based attacks that we were able to perform in our laboratory.” The article
Devices
Kyocera Medical Corp. has received 510(k) clearance for its Initia Total Hip System which features Bioceram Azul (blue) zirconia-toughened alumina ceramic femoral heads. The device is also available with cobalt chrome femoral heads, giving surgeons the option of ceramic or metal heads matched to cross-linked polyethylene acetabular
Devices
FDA has posted a transcript of its 11/2 public meeting on “Medical Device User Fee Amendments” that discussed proposed recommendations for reauthorizing the device user fee program for fiscal years 2018 through 2022. Comments are being accepted on the proposals and FDA will then consider these in revising the
Devices
A federal jury in Dallas has returned a combined verdict of more than $1 billion on behalf of six people who suffered serious medical complications caused by allegedly defective Pinnacle metal-on-metal hip implants made by Johnson & Johnson and subsidiary DePuy Orthopedics. The verdict includes more than $30
Drugs
FDA has stepped up its focus on combination products and plans to finalize its guidance on human factors and GMPs this coming year. In an update on its combination products program, the agency also says it will issue a final rule on postmarket safety reporting, and it will update a
Devices
FDA has cleared a Nanowear 510(k) for its SimplECG, a remote cardiac monitoring undergarment. The device collects continuous multi-channel ECG, heart rate and respiratory rate data from the garment and transfers it to a Web-based portal for review by a physician through a mobile application. “This is
Devices
FDA says that Medtronic has recalled four of its neurovascular products due to potential separation and detachment of polytetrafluoroethylene (PTFE) coating. The FDA notice says this is a Class 1 recall. The affected products are pipeline embolization device, alligator retrieval device, marathon flow directed micro catheter, and X-celerator hydrophilic
Devices
FDA has cleared a BrightWater Medical 510(k) for the ConvertX Nephroureteral Stent System for treating ureteral obstructions, which prevent urine in the kidneys from draining to the bladder. The device is implanted once and converts from a catheter to a stent in an office procedure without the need for
Drugs
FDA published 11/29 in the Federal Register a final rule specifying import data that must be submitted through the agency’s Automated Commercial Environment (ACE) when an FDA-regulated product is offered for import into the U.S. Writing in an FDA Voice blog post, agency deputy commissioner for
Drugs
The day before the House approved (see related coverage) it 11/30, the Rules Committee denied a request by Rep. Louise Slaughter (D-NY) to add an 11th-hour amendment to the 21st Century Cures Act (see earlier story) that would have added an extra layer of adverse event reporting
Devices
FDA e-mails obtained by MobiHealthNews through a Freedom of Information Act request show that FDA and Apple officials have met many times in the last three years, often with the meetings not shown on agency attendees’ calendars. The MobiHealthNews online report details information in e-mails starting in 12/
Devices
Leadership of the American Optometric Association (AOA) met with FDA 11/4 to discuss the group’s concerns with online vision “exams” such as Opternative. “FDA is taking our concerns seriously and is investigating Opternative based on the expansive and detailed complaint AOA filed,” the group says in an online
Devices
Four healthcare organizations are voicing their support for provisions of the MDUFA 4 reauthorization for 2018-2022. The American College of Cardiology says it was interested in three goals in the MDUFA 4 negotiations — a stable, predictable approval pathway; utilization of stakeholder experience; and development of a medical device evaluation
Devices
FDA has posted a guidance on “Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.” The document is intended to highlight the cross-contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes. It also
Drugs
The U.S. House of Representatives has scheduled an 11/30 floor vote on a revised 21st Century Cures bill that includes $6.3 billion in additional funding to accelerate discovery, development, and delivery of new cures and treatments. The measure would provide $4.8 billion to the National Institutes
Devices
FDA has cleared a Toshiba Medical 510(k) for the Forward Projected Model-based Iterative Reconstruction Solution (FIRST) that is intended to improve high contrast spatial resolution while reducing radiation dose up to 85% as compared to filtered back projection computed tomography imaging. “FIRST can improve high-contrast spatial resolution
Drugs
Public Citizen and seven other consumer and government watchdog groups have told FDA that its draft guidance on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees” would allow the agency to continue inappropriately excluding advisory committee members from participating in committee meetings. The groups
Drugs
Attorneys Joanne Hawana and Benjamin Zegarelli (Mintz Levin) say that five recurring themes arose from a recent two-day FDA hearing on the appropriate regulatory approach to manufacturers’ communications about off-label uses for their marketed products. Writing in an online blog post, they summarize the themes as: * Use different
Devices
FDA has been encouraging medical device sponsors to conduct more early feasibility studies (EFS) in the U.S., and it is now suggesting approaches to improving the process based on the agency’s experience with the process. Writing in a recent Journal of the American College of Cardiology article, agency
Devices
FDA is delaying guidelines for regulating laboratory-developed tests until after the Trump Administration takes office in January. Earlier this year, Congressional Republicans (see story) balked at the agency’s plans to finalize guidelines, warning it not to overreach since a draft guidance was released in 2014. House Energy and