Devices
FDA has approved an Abiomed PMA for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps to provide treatment of ongoing cardiogenic shock. “In this setting, the Impella heart pumps stabilize the patient's hemodynamics, unload the left ventricle, perfuse the end organs and
Devices
Industry stakeholders are voicing many concerns about the FDA draft guidance on public notification of emerging postmarket medical device signals. The most comprehensive critique was submitted by the 510(k) Coalition, which “recognizes that FDA is attempting to embark on a major multi-year effort to set up systems to
Devices
FDA is allowing the marketing of Advanced Surgical Concepts’ PneumoLiner, the first tissue containment system for use with certain laparoscopic morcellators to isolate uterine tissue that is not suspected to cause cancer. An agency statement says that although the device is an effective tissue containment system, FDA is requiring its
Devices
The Department of Homeland Security says that independent researchers in collaboration with CareFusion have identified numerous third-party software vulnerabilities in end-of-life versions of the company’s Pyxis SupplyStation system. Because the affected software versions are at end-of-life, the notice says, a patch will not be
Drugs
Life sciences and healthcare respondents to a Deloitte poll say that supply chain fraud increased to 35% of companies in 2016 from 31% in 2014. Overall, poll respondents from many sectors reported that for the third consecutive year, the level of supply chain fraud remained at about 30%. “From a
Devices
FDA has approved a Medtronic PMA for the Micra Transcatheter Pacing System, the first pacemaker that does not require wired leads to provide an electrical connection between the pulse-generating device and the heart. The self-contained, inch-long device is implanted directly in the right ventricle chamber of the
Devices
FDA has released statistics showing a “slight” decrease in medical device manufacturer inspections in 2015 than in 2014, according to attorney Nathan Reeves (Knobbe Martens). Writing in an online blog post, Reeves says there were 2,104 inspections in 2015, compared with 2,213 in 2014. “Despite the drop of
Devices
FDA has cleared an Advanced Brain Monitoring 510(k) for its Sleep Profiler, an overnight sleep monitor and electroencephalogram for patients with insomnia or mood disorders that is intended for diagnosing sleep apnea. “Clinical study results, required for FDA clearance, showed the Sleep Profiler PSG2 delivers unparalleled accuracy in the
Devices
The Federal Trade Commission (FTC), working in conjunction with FDA and the HHS Office of National Coordinator for Health Information Technology and Office for Civil Rights, has developed a Web-based tool for designers of health-related mobile apps to help developers understand what federal laws and regulations might apply
Devices
Focus Diagnostics has begun a Class 1 recall of its Direct Amplification Discs supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because they may result in a false negative result, a false
Devices
The American Optometric Association (AOA) has filed a complaint with FDA urging it to take legal action against an online vision test being marketed by Opternative, Inc. without the type of testing and pre-market approvals frequently required of new medical device technology. The online test produces a prescription for
Devices
FDA has approved a CardioFocus PMA for its HeartLight Endoscopic Ablation System for treating patients with paroxysmal atrial fibrillation (AF). The device differs from other AF options that rely on x-ray or mapping support for guidance, by allowing the electrophysiologist to control the delivery of therapeutic laser energy “for
Devices
A Duke-Margolis Center for Health Policy white paper outlines the business practices of a proposed independent coordinating center that would guide the future development and implementation of CDRH’s national evaluation system for medical devices. Establishing the device evaluation system is a top strategic priority for 2016-2017. The
Devices
The FDA says it is aware of allegations that Boston Scientific’s urogynecologic surgical mesh may contain counterfeit raw material, and it is requiring the company to conduct additional testing to determine whether or not mesh manufactured from the alleged counterfeit raw material are equivalent to mesh manufactured from the
Devices
FDA has established a Library of Quality Practices as a resource for medical device professionals seeking to identify tools that can help them develop and update their approach to quality in their device design and manufacturing. The resources were developed as part of CDRH’s Case for Quality initiative. The
Devices
Houston-based Mostyn Law has petitioned FDA asking that it order a recall of Boston Scientific’s surgical mesh products because they are allegedly made of defective, counterfeit material from China. The petition, filed on behalf of a West Virginia woman who suffered health problems from a Boston Scientific pelvic
Devices
FDA says it has received reports of adverse effects and has updated its recommendations involving CT scans when patients have insulin pumps, cardiac implantable electronic devices, or neurostimulators. An agency Web site says that while most patients undergo CT scans without any adverse consequences, FDA has received a small number
Devices
FDA has cleared a Medtronic 510(k) for its PillCam COLON 2 capsule for an expanded indication — detecting colon polyps in patients with evidence of gastrointestinal bleeding of lower gastrointestinal origin. The device was originally cleared to visualize the colon for evaluating polyps in patients who are at major risks
Devices
FDA has cleared an Xtant Medical Holdings 510(k) for the Xspan Laminoplasty Fixation System and its use in the lower cervical and upper thoracic spine (C3-T3). Spinal laminoplasty is a surgical procedure performed to remove pressure from the spinal cord, according to the company. “Unlike a laminectomy, where
Devices
FDA says a 6/2015 recall by OxySure Therapeutics involving its OxySure replacement cartridges for the OxySure Portable Emergency Oxygen System Model 615 was ineffective. A new agency alert recommends that consumers, businesses, schools, and health care providers stop using the devices because of several device malfunctions, including ineffective oxygen
Devices
CDRH has added four new learning modules on unique device identifiers to its online learning catalog “CDRH Learn.” The new modules are: 1. Unique Device Identification (UDI) System Regulatory Overview (New module 3/29/16) Presentation Printable Slides Transcript 2. Global Unique Device Identification Database (GUDID) Account Request: Preparation and
Devices
The CDS (Clinical Decision Support) Coalition has reiterated its request for more clarity on regulations governing the clinical decision support software industry. The request came in response to the Senate HELP Committee supporting the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) bill at a 3/9 committee hearing.