Devices
The National Evaluation System for health Technology (NEST) has test cases underway to demonstrate proof-of-concept for generating robust real-world evidence (RWE) in preparation for regulatory submissions such as label expansions or to meet postmarket surveillance requirements. Writing in a Clinical Pharmacology & Therapeutics commentary, CDRH director Jeffrey
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Mobilett Elara Max mobile X-ray system, which features improved information technology (IT) security as well as secure system integration into a hospital’s IT environment for immediate access to patient data. The system also has an improved design that
Devices
FDA has issued Warning Letters to two breast implant manufacturers for failing to comply with post-market study requirements included in their premarket approval orders. The studies were to assess the long-term safety and risks of the companies’ silicone gel-filled implants. Warning Letters went to Mentor Worldwide, Irvine,
Devices
A 10/9-11/2/18 FDA inspection at Integra LifeSciences’ TEI Biosciences unit in Boston, MA, found Quality System Regulation violations in the firm’s manufacturing of collagen-based medical devices used for wound care, soft tissue repair, and reconstruction therapy. A 3/6 Warning Letter says the specific
Devices
The Consumer Healthcare Products Association (CPHA) says that while it agrees with several principles underlying an FDA draft guidance on content of premarket submissions for managing medical device cybersecurity, there are several elements that should be clarified. In a comment letter CPHA highlights these points: (1) FDA should clarify the
Devices
FDA has cleared an Atreon Orthopedics 510(k) for the Rotium Bioresorbable Wick, intended for use in supporting healthy tendon regeneration related to rotator cuff injuries. The synthetic bioresorbable scaffold is designed to be positioned between the repaired tendon and the bone and acts to facilitate and enhance the healing
Devices
The FDA Neurological Devices Panel will be asked to comment 3/21on clinical data submitted in a Neuronix PMA for NeuroAD that did not meet its primary efficacy point in a pivotal trial. The device is proposed as an adjunctive treatment for mild to moderate dementia of the Alzheimer’s
Devices
FDA has cleared a Via Surgical 510(k) for the FasTouch Absorbable Fixation System, which features automated lockable surgical mesh fixation. The device is intended to attach prosthetic material to soft tissues in various surgical procedures such as hernia repairs. “Our data clearly demonstrates that a lockable solution is more
Devices
FDA has cleared an Intuitive 510(k) for the da Vinci SP robotic surgical system for use in certain transoral otolaryngology procedures in adults. FDA cleared the single port approach for lateral oropharyngectomy procedures (also referred to as radical tonsillectomy) and tongue base resection. The device includes three, multi-jointed,
Devices
Cook Medical has begun recalling (Class 1) one lot of the Transseptal Needle due to a manufacturing error that resulted in some needle tips missing the back bevel that creates a sharp tip. “Without a back bevel, the needle tip could damage the inside of the introducer sheath during insertion
Devices
FDA says that this fall it plans to hold an advisory committee meeting to discuss nitinol and other metals in device implants to understand the potential risk for certain patients with hypersensitivity or exaggerated immune and inflammatory reactions to the metals. “We’ve been exploring the link between immune and
Devices
An updated FDA safety alert on paclitaxel-coated products says that a preliminary data review has identified a potentially concerning signal of increased long-term mortality in study subjects compared to patients treated with uncoated devices. The study examined three trials with five-year follow-up data. “In total,"
Devices
FDA has cleared a Thornhill Research de novo marketing request for the ClearMate, intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning. The device uses a novel method for quickly removing carbon monoxide from the body by increasing a patient’s
Drugs
FDA has issued a draft guidance, A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers, with guidance on risk-based approaches to monitoring investigational studies of human drugs and biological products, medical devices, and combinations. The document has recommendations on planning a monitoring approach, developing the content
Devices
FDA has issued a guidance, Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), to update agency policy regarding use of animal-derived material in medical device manufacturing. “The role of animal-derived material in medical devices is well-established,” the document says. “However, these
Devices
FDA has approved Biotronik’s Acticor and Rivacor high-voltage cardiac rhythm management (CRM) device lines for treating patients with cardiac arrhythmias. The devices are: Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX. They are designed with advanced
Devices
FDA has approved a new indication for the Abbott Vascular MitraClip for treating patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation because of diminished left heart function despite being treated with optimal medical therapy. An agency statement says the MitraClip
Devices
FDA has approved a BD (Becton Dickinson) PMA for the Venovo venous stent, indicated for treating iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow specific to the iliac and femoral veins located near the groin. The flexible nitinol stent is designed to reopen blocked iliac and femoral
Devices
CDRH is implementing a reorganization that will combine the Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and the Office of In Vitro Diagnostics and Radiological Health into one super office — Office of Product Evaluation and Quality. It will be focused on a “Total Product Life
Devices
GE Healthcare says the concept of the FDA software precertification program “maintains FDA’s gold standard in ensuring safety and effectiveness of software medical devices, while providing faster access to market for software devices developed by trusted pre-certified organizations.” The company says that accelerated pathway is crucial in helping
FDA Policy/General
The Justice Department says Covidien has agreed to pay $17,477,947 to resolve whistleblower allegations it violated the False Claims Act by providing free or discounted practice development and market development supports to doctors in California and Florida to induce purchase of the company’s vein ablation products. The
Devices
FDA has qualified the OsiriX CDE software module from the TBI Endpoints Development Initiative as the first biomarker test tool type to be qualified. The agency says it is the third medical device development tool (MDDT) it has qualified. The qualification is said to provide a tool for more efficient