Devices
FDA has cleared an Acutus Medical 510(k) for an expanded suite of left-heart access products to include the AcQCross Qx system for use with the TruSeal and FXD delivery system for the Watchman Left Atrial Appendage Closure device. “Gaining access to the left atrium requires physicians to cross
Devices
FDA has granted Carthera a breakthrough device designation for its SonoCloud-9 system, a device that uses low intensity pulsed ultrasound to temporarily disrupt the blood-brain barrier (BBB) to allow higher brain exposure to therapeutic compounds. “By using SonoCloud, the therapeutic efficacy of new and existing therapies can be
Devices
FDA says Baxter Healthcare’s 4/26 recall of 268 units of its Volara system with an in-line ventilator adaptor is Class 1. An agency notice says the devices were distributed between 5/28/20 and 4/19/22. The system is intended to help people clear mucus out
Drugs
New York University bioethics professor Arthur Caplan says that among all the efforts to increase clinical trial diversity, what’s missing is a clear explanation of why it is so important. In a Stat First Opinion post, Caplan reviews some recent announcements from FDA and other stakeholders calling for greater
Devices
Medtronic has recalled (Class 1) one lot of batteries for its HeartWare Ventricular Assist Device (HVAD) due to welding defects that allow separation of the two cell battery packs used to power the device. The defects may cause the battery to malfunction and no longer provide power or prevent the
Devices
FDA has given 510(k) clearance and breakthrough device designation to Medtronic’s LigaPASS 2.0 ligament augmentation system. The company says it is the only FDA-cleared device indicated for ligament augmentation in spine surgery. The system “aims to compensate for muscle collapse during open posterior surgery and decrease
Devices
BD is recalling its BD intraosseous needle set kits, BD intraosseous manual driver kits, and BD intraosseous power drivers. A company statement says certain lots within the expiration dates of the products may result in: * difficulty separating the stylet from the intraosseous needle, where the increased force required to remove
Drugs
The 4th Circuit Court of Appeals has upheld a West Virginia law regulating ads that solicit plaintiffs for lawsuits involving drugs or medical devices. The appeals court reversed a district court decision that struck down the law on First Amendment grounds. Writing in a Washington Legal Foundation Legal Opinion Letter,
Devices
Draeger has recalled (Class 1) one lot (#LT2103) of its SafeStar 55 Breathing System Filter because a manual inspection process revealed that some defective filters, including several that may be partially obstructed, were inadvertently distributed instead of destroyed. The filter, which is used as part of a ventilator when a
Devices
CDRH has released a draft guidance entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.” The document provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems. Tissue containment
Devices
Some 30 Republican members of the House have written to President Joe Biden asking him to work to alleviate a shortage of intravenous contrast fluids in hospitals. A statement (includes the text of the letter) from Rep. Dan Newhouse (R-WA), one of those signing the 6/14 letter, says
Devices
FDA has published a guidance, Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions, with recommendations for manufacturers about information that should be in premarket submissions for radiological devices that include quantitative imaging functions. The document clarifies that, in general, manufacturers preparing premarket submissions (PMA, HDE, 510(k)
Drugs
Three Troutman Pepper attorneys say a 4/14 FDA draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials, is the agency’s first attempt to articulate detailed expectations for submission of a plan by trial sponsors to ensure that clinical trial
Devices
FDA says it has contracted with Research Triangle Institute International to study how patients weigh the benefits and risks associated with smooth and textured breast implants. An agency announcement says CDRH believes the survey results will help assess whether patients’ perception of the risk of breast implant-associated anaplastic large
Devices
FDA has provided an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections in patients who have undergone cardiothoracic surgery using the devices. The agency says that last month it cleared the Spectrum Medical Quantum Heater-Cooler and the compatible Qura Quantum PureFlow
Devices
FDA has cleared an Ekso Bionics Holdings 510(k) to market its EksoNR robotic exoskeleton for use with multiple sclerosis patients. The device was cleared for stroke and spinal cord injury rehabilitation in 2016, and acquired brain injury in 2020. It features software to customize motor support strength for various
Devices
FDA has updated a Class 1 recall notice involving Woodside Acquisitions’ Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold). The notice says the firm’s name does not appear on the tests’ labels. It also clarifies that
Devices
FDA has granted an emergency use authorization (EUA) for Laboratory Corp. of America’s VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system. The test addresses the need to identify Covid-19 mutations that have resulted in genetic variation in circulating virus strains, also called lineages.
Devices
FDA has cleared Thermo Scientific 510(k)s for its EliA RNA Pol III and EliA Rib-P tests for aiding in the diagnosis of systemic sclerosis (SSc; scleroderma) and systemic lupus erythematosus (SLE). “RNA Polymerase III is a criteria marker for SSc with both diagnostic and prognostic value,” the
Devices
FDA has approved a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for the two approved indications for Genentech’s Rozlytrek (entrectinib). In 2019, FDA approved Rozlytrek for treating adult and adolescent patients whose cancers have the specific genetic defect NTRK (neurotrophic tyrosine receptor
Devices
FDA has given a Class 1 designation to a recall of GE Healthcare’s ventilator batteries used in certain Carescape R860 Ventilators due to insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to an AC power supply. Affected devices were initially recalled 4/18
Drugs
CDER has published a Manual of Policy and Procedures (MAPP), Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA, to describe how the Office of Generic Drugs (OGD) and the Office of Surveillance and Epidemiology (OSE) will assess the