Devices
Since 2015, CDRH and CBER have granted 1,041 Breakthrough Device designations, with CDRH granting 1,029 designations and CBER granting 12. The totals include devices originally designated under the former Expedited Access Pathway, according to the FDA Breakthrough Device Program Web page. There were 206 devices designated in Fiscal
Devices
FDA has granted a de novo marketing authorization to Omron Healthcare for its new home blood pressure monitors featuring artificial intelligence (AI)-powered atrial fibrillation detection. The company says its novel machine learning IntelliSense AFib algorithm automatically analyzes the pressure pulse wave generated during blood pressure measurement to detect AFib,
Drugs
The Sedgwick Recall Index says that for the third quarter of 2024, U.S. medical device recall events increased 8.3% from 242 in the second quarter to 262. The increase means that 2024 is on track to reach a three-year high, the Sedgwick report says. Device failure was
Devices
FDA has granted SonoMotion a de novo marketing authorization for its Stone Clear device for the anesthesia-free treatment of post-lithotripsy kidney stone fragments. The device is designed to deliver ultrasound pulses externally to move and help the passage of residual fragments without surgery, according to the company. The
Devices
FDA has cleared a NovaBone Products 510(k) for its bioactive synthetic bone graft, NovaBone Putty, and its expanded use in the intervertebral disc space. The clearance covers the device’s use in the intervertebral disc space alongside FDA-cleared interbody fusion devices, NovaBone says. The company says the device
Biologics
Six Squire Patton Boggs attorneys say that at the end of the Supreme Court’s 2023-2024 term, the court issued four decisions that “have potentially wide-ranging consequences on federal agency rulemaking, adjudication, and regulatory compliance.” Writing in an online post, the attorneys analyze the impact of the decisions
Devices
LivaNova says its aura6000 system, indicated to treat obstructive sleep apnea using targeted hypoglossal nerve stimulation, met the primary safety and efficacy endpoints in the OSPREY trial. A company statement describes the aura6000 as an implantable hypoglossal neurostimulator intended to treat adults with moderate to severe obstructive sleep apnea. Once
Drugs
Speaking on a Government Accountability Office (GAO) podcast, GAO healthcare director Mary Denigan-Macauley says FDA needs to have a plan to address all of the causes that make it difficult to recruit facility inspectors and a strategy for retaining new hires. The podcast focuses on foreign and domestic facility
Devices
FDA has cleared a GE HealthCare 510(k) for its Signa Magnus, a 3.0T high-performance, head-only magnetic resonance imaging scanner. The device features an asymmetrical, head-only gradient coil design that “shifts the gradient isocenter to the patient edge of the coil rather than its geometric center,
Devices
An 8/5-8/14 FDA inspection at Owens & Minor, doing business as American Contract Systems, in Mechanicsville, VA, found Quality System Regulation violations in the firm’s manufacturing of sterile convenience kits such as a C-Section Pack. An 11/1 Warning Letter says the specific violations were:
Drugs
The Republican leadership of the House Energy and Commerce Committee is asking the Government Accountability Office (GAO) to “examine the structure of laboratory safety programs” at FDA, the Centers for Disease Control (CDC), and the National Institutes of Health. An 11/12 committee statement (includes a link to a letter
Devices
FDA has sent Warning Letters to two overseas manufacturers of x-ray equipment. The 10/18 letter to Rolence Ent. Inc. in Taoyuan City, Taiwan, follows a 7/8-7/11 inspection there that found Quality System Regulation violations in the manufacturing of the XR-01 portable x-ray system.
Devices
FDA has cleared a Foundation Surgical 510(k) for its Vertiwedge Intraosseous, a motion-sparing partial vertebral body replacement device intended for use with the company’s Vertebral Body Osteotomy procedure. Vertiwedge is described as the “first intraosseous device designed to facilitate and maintain vertebral body correction of partially collapsed
Devices
FDA has cleared a Bayer 510(k) for its Medrad Centargo CT Injection System, a multi-patient injector for use in computed tomography. The device is designed to minimize prep time as the daily set-up can be completed in under two minutes with the pre-assembled Day Set, the
Devices
Elekta Instrument AB has recalled (Class 1) its Elekta Disposable Biopsy Needle Kit for the Leksell Stereotactic System, which is used for localization and diagnosis of intracranial disorders and their surgical treatment, including radiosurgery and stereotactic radiation therapy. “Elekta has become aware that the Disposable Biopsy Needles can contain some
Devices
FDA says its analysis of form FDA-483s issued for Good Laboratory Practice inspection observations in FY 2023 found one overriding trend — inadequate training at multiple levels. The agency analysis says that 28 nonclinical inspections were conducted in FY 2023, with a form FDA-483 issued following 10 of them.
Devices
FDA has approved the Johnson & Johnson Varipulse pulse field ablation platform to treat atrial fibrillation. A company statement says Varipulse is the only pulse field ablation system in the U.S. fully integrated with the J&J CARTO 3 electro-anatomical mapping system, driving efficiency, reproducibility, and accuracy.
Drugs
FDA has released its analysis of FY 2023 institutional review board (IRB) violations based on the form FDA-483s that were issued. The report says that broadly written regulations do not always convey the specific details of the observed violations. The agency says it reviewed and sub-categorized FDA-483
Devices
FDA has granted de novo authorization to LumiThera for its Valeda light delivery system to treat patients with dry age-related macular degeneration (AMD). The company says the Valeda therapy is the first authorized treatment for vision loss in dry AMD patients. “Valeda provides an improvement in best corrected visual
Devices
Although the American Clinical Laboratory Association maintains that FDA lacks authority to regulate laboratory-developed tests (LDTs), it is submitting comments to an agency draft guidance on predetermined change control plans (PCCPs) for medical devices. “In the event that FDA’s final rule to regulate LDTs as medical devices is
Devices
FDA has granted a breakthrough device designation for SeaStar Medical’s Selective Cytopheretic Device (SCD) to treat chronic systemic inflammation in end-stage renal disease patients who require chronic hemodialysis. A company statement says the SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target
Devices
FDA has cleared a Zeta Surgical 510(k) for its Zeta Navigation System for use with expanded instruments and enhanced hospital connectivity. The device is designed to provide “rapidly deployable, high-accuracy navigation” for neurological interventions currently unsupported by existing navigation systems, according to the company “Its GPS-like guidance