Devices
Abiomed says it is recalling all lots of six models of its Impella heart pumps that are used in patients with a transcatheter aortic valve replacement (TAVR). A company notice says there is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a
Devices
FDA has cleared a MediView XR 510(k) for its XR90 augmented reality (AR)-based surgical visualization and navigation platform. XR90 is intended to be used in ultrasound and CT guided needle-based procedures involving soft tissue and bone, the company says. “XR90’s augmented reality capabilities include a holographic
Devices
FDA has cleared a University of Utah Orthopedic Innovation Center 510(k) for its Bone Bolt System, an implant for percutaneous bone fracture fixation. The university says the system is a “comprehensive set of implants of various lengths and diameters, along with associated surgical instruments and sterilization trays.” The implants
Devices
FDA is recommending that healthcare providers, laboratory personnel, and facilities stop using the Quidel Triage Cardiac Panel manufactured by Quidel Cardiovascular. A 7/19 agency notice says the company issued an urgent product correction notification on 5/25 recalling specific lots of the device after hearing that tests provide inaccurate,
Devices
A 3/20-4/4 FDA inspection at Edge Biologicals in Memphis, TN, found eight repeat violations in the firm’s manufacturing of Class 1 and 2 in vitro diagnostics for medical applications. A 6/27 Warning Letter says the devices are adulterated due to violations of the current good
Devices
NOxBOX has recalled its NOxBOXi Nitric Oxide Delivery System due to a check valve misalignment in the device’s manifold, which may cause it to malfunction. “The device may also change gas cylinders earlier than expected or not at all,” a recall notice says. “This issue may lead to interrupted
Devices
FDA has given 510(k) clearance to the ReddyPort elbow device used in non-invasive ventilation. A company statement says the elbow features a self-sealing valve that provides seamless oral access to the patient’s mouth without the need for mask removal, alleviating the risk of therapeutic pressure loss
Devices
A 1/17-2/10 FDA inspection at Outset Medical in San Jose, CA, found that the company manufactures the Tablo Hemodialysis System and TabloCart with Prefiltration. A 7/5 Warning Letter says Outset does not have approved applications for PMA approval for either of the devices, rendering them both
Devices
Medtronic has recalled (Class 1) its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with glassed feedthrough due to a potential faulty short circuit protection feature. A recall notice says the glassed feedthrough devices “may deliver low or no energy output when high voltage therapy is needed due to inappropriate
Biologics
The Government Accountability Office (GAO) says its study of regenerative medicine led to the development of 11 policy options, several of which involve FDA. GAO says it conducted an assessment of current and emerging regenerative medicine technologies and therapeutic applications. The report looks at (1) current and emerging regenerative medicine
Devices
FDA has issued a warning against using ultrasound medical devices manufactured and distributed by RoyalVibe Health, and related companies CellQuicken and Well-Being Reality. The agency says the devices have not been reviewed for safety or effectiveness, and using them “may result in adverse effects, including pain, bruising, burns, scarring,
Devices
Quidel Cardiovascular has recalled (Class 1) the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower-than-expected troponin levels in samples. “A falsely low or false negative troponin level may cause a delayed or missed diagnosis of myocardial infarction — a serious, potentially fatal condition that requires the
Devices
FDA has made minor changes to its final guidance entitled “Qualification of Medical Device Development Tools (MDDTs).” The document describes the agency’s voluntary program for qualifying MDDTs for use in evaluating devices regulated by CDRH. The Center says the following minor procedural updates and clarifications were made to the
Devices
FDA has cleared a MedRhythms 510(k) for InTandem, a neurorehabilitation system to improve walking and ambulation in adults with chronic stroke walking deficits. The device delivers an intervention based on rhythmic auditory stimulation, a “well-researched clinical intervention utilizing the mechanism of auditory-motor entrainment, through which the motor
Devices
FDA has cleared an EarliTec Diagnostics 510(k) for the second generation of its EarliPoint Evaluation for Autism Spectrum Disorder in children ages 16 to 30 months old. The updated device displays curated scenes of social interactions on a portable tablet. “Eye-tracking technology measures more than 120 focal preferences
Drugs
While FDA continues to pursue a new regulatory paradigm for laboratory-developed tests (LDTs), the agency is starting a new pilot program to add more regulatory teeth to LDTs that are used without an approved companion diagnostic for certain oncology drugs. Speaking at a Friends of Cancer Research (FOCR) public
Devices
A 12/5-12/13/2022 FDA inspection at Zyto Technologies in Lindon, UT, determined that the company manufactures the Zyto Hand Cradle Galvanic Skin Response device and associated proprietary software used to scan patients to identify “stressors” and “balancers.” A just-released 6/21 Warning Letter says some of
Devices
FDA has posted an online information page on the surgical mesh used for hernia repair. The page defines hernias and their types and causes, treatment options, surgical mesh, and additional resources. On the page, FDA discusses non-surgical and surgical options for treating hernias and explains how surgical mesh is
Devices
Draeger Medical is recalling (Class 1) its Oxylog 3000 Plus Emergency and Transport Ventilator after receiving reports that the device stopped ventilation because of a depleted battery. The device stoppages also occurred after being re-connected to AC power, a recall notice says. “The ventilator may not automatically switch back
Devices
FDA has approved Boston Scientific’s Vercis Neural Navigator 5 Software, which is used as part of the Vercise Genus Deep Brain Stimulation (DBS) System to provide clinicians with with what the company calls “simple and actionable data for efficient programming” in treating people with Parkinson’s disease or essential
Devices
Megadyne is recalling its MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving reports of pediatric and adult patients receiving burns. “These burns may be as serious as third-degree burns requiring medical intervention and may lead to a longer hospital stay, scarring, and potentially more surgeries for
Devices
FDA says that as a result of additional data and analyses, it now no longer believes there is an excess mortality risk for paclitaxel-coated devices used to treat peripheral arterial disease. An agency 7/11 letter to healthcare providers reverses the announcement in a 1/17/2019 letter of