Devices
A Pennsylvania federal court has asked the 3rd Circuit Court of Appeals to answer whether the state recognizes a strict liability claim for a manufacturing defect of a prescription medical device. A Washington Legal Foundation (WLF) Legal Pulse online post says the Pennsylvania case is similar to one pending in
Devices
FDA has posted a final guidance entitled “Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.” The document is intended to provide factors to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted under an IDE. It provides information about a live case
Devices
FDA has cleared a Centerline Biomedical 510(k) for the Intra-Operative Positioning System. The non-radiation-based surgical navigation system “leverages anatomical mapping algorithms and electromagnetic tracking technology to provide three-dimensional color visualization and guidance in real time during endovascular procedures,” the company says. It was developed at
Devices
FDA has cleared a Biotronik 510(k) for the Biomonitor III injectable cardiac monitor. The device is designed to document suspected arrhythmia or unexplained syncope with increased clarity, enabling fast diagnosis and appropriate treatment, the company says. Biomonitor III is 60% smaller than its predecessor and comes “pre-loaded in
Drugs
Four K&L Gates attorneys dissect two Justice Department policy statements and their impact on healthcare companies and their law firms in an online blog post. The attorneys first examine a 1/2018 memo issued by Civil Fraud Division director Michael Granston to determine what has happened over the
Devices
A 4/3-4/4 FDA inspection at Clinicon Corp., Oceanside, CA, found Quality System Regulation violations in the firm’s work as a manufacturer (specification developer) of the SureProbe Class 2 sterile, single-use, laser accessory probes, among other devices. A 6/20 Warning Letter says specific violations were:
Devices
Civil and criminal penalties in cases involving an ACell medical device deserve further study by other device companies, according to attorneys Anne Walsh and Adrienne Lenz (Hyman, Phelps & McNamara). In a blog post for their firm’s FDA Law Blog, the two first discuss two whistleblower cases alleging that
Devices
Edwards LifeSciences has recalled its IntraClude Intra-Aortic Occlusion Device due to balloon rupture risks during use, which could add time to the procedure and compromise patient safety. The balloon bursting “may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass, including neurological damage,
Devices
Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) have written to FDA acting commissioner Ned Sharpless expressing their opposition to the CDRH “progressive approval for devices” program in the FDA FY 2020 budget that appears to expand the agency’s “conditional approval” pathway for animal drugs to human
Devices
FDA has issued two guidances relating to the CDRH appeals process. The first, Center for Devices and RadiologicalHealth (CDRH) Appeals Processes, describes processes available to outside stakeholders to request additional review of decisions or actions by CDRH staff. The document notes that individuals outside FDA who disagree with a CDRH
Devices
An online Kaiser Health News post lists five key items the service found in its review of a recently published FDA “alternative summary” database often used by medical device manufacturers to report injuries or malfunctions, bypassing the public MAUDE database used by doctors, researchers, and patients. The news service says
Devices
FDA says 11 Medtronic MiniMed and MiniMed Paradigm insulin pumps have potential cybersecurity risks and diabetes patients using the specific models should switch their insulin pump to models that are better equipped to protect against the potential risks. An FDA safety communication lists the 11 affected models and offers recommendations
Devices
Vyaire Medical has recalled its enFlow Fluid Warming System disposable cartridges due to the potential for aluminum to elute from the warmer into the fluids, which could expose patients to unsafe levels of aluminum. “Exposure to unsafe levels of aluminum may result in serious adverse health consequences including, but not
Devices
FDA has published a guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, with recommendations for manufacturers seeking marketing clearance for diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, the document describes the types of modifications to a diagnostic ultrasound device for
Devices
FDA has issued a draft guidance, Clinical Investigations for Prostate Tissue Ablation Devices, with recommendations for (1) complying with the clinical testing special control for 510(k)s for high-intensity ultrasound systems for prostate tissue ablation, and (2) collecting clinical data to support marketing submissions for new types of
Devices
FDA has cleared a Viveve Medical 510(k) for the company’s next-generation Viveve 2.0 cryogen-cooled monopolar radiofrequency system for use in general surgical procedures for electrocoagulation and hemostasis. The company says its device’s controlled cooling protects the tissue surfaces from any damage and impacts the
Devices
A 3/15-3/19 FDA inspection at International Hospital Products, Littleton, CO, found Quality System Regulation violations in the firm’s work as a manufacturer (specification developer) of Class 2 Baker Jejunostomy and intestinal tubes used for bowel decompression. A 5/29 Warning Letter says specific violations were: * failing
Biologics
The Healthcare Distribution Alliance says it commends FDA for issuing a draft guidance on initiating voluntary recalls and the clarity and assistance it offers to recalling firms and their trading partners. It also says the draft is not aligned with Drug Supply Chain Security Act requirements and explains its detailed
Devices
A 6/19-20 meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee unanimously agreed that data show a mortality signal associated with paclitaxel-coated products (e.g., balloons and stents) used to treat peripheral arterial disease in the femoropopliteal arteries. However, panel members were uncertain
Devices
CDRH has ended its Alternative Summary Reporting (ASR) program and issued revocation letters to 13 remaining manufacturers with ASR exemptions, which covered three kinds of devices: dental implants, implantable cardiac defibrillators and pacemaker electrodes. Under the program, certain device makers could “request an exemption from the requirement to file individual
Devices
Teleflex Medical has recalled multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes due to complaints about the device’s connector disconnecting from the breathing circuit. Each tracheal tube includes an appropriately sized 15mm connector. Teleflex Medical has received 179 complaints with 192 occurrences associated with the device
Devices
Opko Health has submitted a de novo request to FDA seeking regulatory clearance for the 4Kscore, a blood test for intended use by health care professionals to assess a patient’s risk of having aggressive prostate cancer after an abnormal prostate specific antigen test result, and before a decision is