Devices
An 8/14-8/18/17 FDA inspection at SynCardia Systems, Tucson, AZ, found Medical Device Reporting violations associated with the firm’s manufacturing of the SynCardia Total Artificial Heart System, according to a 4/3 Warning Letter. Specific violations cited in the letter were: * failing to report to FDA
Devices
FDA has approved an Abbott firmware update for its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to battery and cybersecurity concerns. The corrective action (recall) is intended to “reduce the risk of patient harm due to premature battery depletion and potential exploitation of cybersecurity vulnerabilities
Drugs
FDA has released a draft guidance for industry entitled “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.” The document, which was developed by the agency’s Oncology Center of Excellence, CDER, CBER and CDRH. It describes an optional streamlined submission process for determining whether
Devices
Fresenius Kabi USA has initiated a mandatory “field action” software update for its Alyx Component Collection System because of an issue identified when the Alyx instrument is used for the red blood cell (RBC)/plasma procedure. “Pre-leukoreduced RBC volumes as low as 172 mL for a 200 mL target
Devices
FDA has released a final guidance on “Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices.” The document describes agency recommendations for complying with the performance standard requirements for ultrasonic diathermy devices in 21 CFR 1050.10 where a manufacturer has otherwise complied with certain International Electrotechnical
Devices
A state court jury in New Jersey has handed down a $33 million verdict against C.R. Bard in a product liability lawsuit involving its allegedly defective pelvic mesh implants. Numerous pelvic-mesh related lawsuits are consolidated in the state, according to Courtroom View Network (CVN). The Bergen County jury
Devices
FDA has approved a TransMedics PMA for the Organ Care System Lung platform for use in standard double lung transplants. Approval was based on data from the INSPIRE Trial, the first and largest controlled clinical organ preservation trial in lung transplantation that was conducted at 21 leading international academic institutions,
Devices
Federal Register notice: FDA has made available a draft guidance entitled “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria.” The document describes an optional program for certain well understood device types, where a submitter could demonstrate that a new device meets FDA-identified performance criteria
Devices
FDA has finalized two guidances intended to drive development of next generation sequencing (NGS) that scans an individual’s DNA to diagnose genetic diseases and guide medical treatment. An agency statement (includes links to the guidances) says the documents provide recommendations for designing, developing, and validating tests that use NGS.
Drugs
A joint HHS/Justice Department Healthcare Fraud and Abuse Control Program won or negotiated over $2.4 billion in healthcare fraud judgments and settlements in FY 2017, according to a just-released report. In FY 2017, the report says, the Justice Department opened 967 new criminal healthcare fraud investigations. Federal
Devices
FDA has published a draft guidance, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria, with the agency’s current thinking on expanding use of the abbreviated 510(k) program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. “The intent of the guidance is
Devices
Innovative Health Solutions is petitioning FDA not to make a determination of certain subject devices’ substantial equivalence to its NSS-2 Bridge nerve stimulator without preclinical studies and at least one clinical trial establishing non-inferiority of the subject device to the NSS-2 Bridge in head-to-head evaluations.
Devices
FDA has cleared a Lensar 510(k) for the Lensar Laser System with Streamline IV, that expands the platform’s capabilities to include the creation of the corneal pockets and flaps used in ophthalmic procedures treating presbyopia. The enhancement includes a new curved contact patient interface device that enables the
Devices
FDA has allowed the de novo marketing of IDx LLC.’s IDx-DR, a software program that uses an artificial intelligence (AI) algorithm to analyze images of the eye taken with a retinal camera to detect greater than a mild level of diabetic retinopathy. Diabetic retinopathy occurs when high blood
Devices
FDA has cleared a Varian 510(k) for a new version of its Velocity cancer imaging software which includes Rapidsphere, a module for Y90 Selective Internal Radiation Therapy (SIRT) dosimetry analysis. The company says Rapidsphere allows cancer care teams to better understand tumor response and normal-tissue toxicity for individual
Devices
FDA has cleared a Johnson & Johnson Vision Care 510(k) for the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are indicated for daily use to correct the vision of
Devices
FDA says that Custom Ultrasonics has completed validation testing of its System 83 Plus automated endoscope reprocessors with specific duodenoscopes and the agency has determined that the validation data demonstrate that the System 83 Plus can effectively achieve high-level disinfection of the Olympus TJF-180V duodenoscope and the Pentax
Devices
FDA has issued an order that will restrict the use of Bayer’s controversial Essure birth control device to ensure that all women considering the device are provided with adequate risk information. The agency action is in response to it becoming aware that some women were not being adequately informed
Devices
FDA has cleared a Fischer Medical 510(k) for the Bloom2 stimulator as a component of electrophysiology (EP) procedures to diagnose and treat cardiac rhythm disorders. The digital device is intended to provide electrophysiologists and EP staff members a modern user interface. It eliminates “tedious dropdown menus and retains the
Devices
Phadia U.S. has recalled its ImmunoCAP Allergen c5, Ampicilloyl due to stability concerns. The in vitro quantitative assay is intended for use in measuring allergen-specific IgE in human serum or plasma. An FDA recall notice says the stability concern is related to the device’s design. Users are
Drugs
The 3rd Circuit Court of Appeals has reiterated the notion that evidence of an actual false claim is necessary for a False Claims Act suit to succeed. Attorneys Kristin Koehler and Joshua Fougere (Sidley Austin) write in a Washington Legal Foundation Legal Opinion Letter that the 3rd Circuit ruling “should
Devices
FDA has cleared a Sonoma Pharmaceuticals 510(k) for an antimicrobial post-therapy gel, intended for use in managing post-non-ablative laser therapy procedures and post-microdermabrasion therapy as well for use following superficial chemical peels. The company says it may also be used to relieve itch and pain