Devices
FDA has released a guidance entitled: “Medical Device User Fee Small Business Qualification and Certification.” The document says that a business that is qualified and certified as a “small business” is eligible for a substantial reduction in most user fees. Application types eligible for reduced small business fee are: Premarket
Devices
FDA has cleared a Sensus Healthcare 501(k) for its new SRT-100+, a next-generation Superficial Radiation Therapy solution that adds several features to its existing SRT-100 product, intended for use in treating non-melanoma skin cancers and keloids. The new device features live lesion and patient cameras
Devices
FDA has cleared a Hologic 510(k) for its Group B Streptococcus (GBS) assay on the Panther Fusion system. The company says clinical research has showed that the assay exhibited 100% sensitivity compared to culture-based testing methods. “The assay will also increase testing options for healthcare providers, as it
Devices
Modulated Imaging has received FDA clearance for its Clarifi Imaging System, a diagnostic device that uses spatial frequency domain imaging to help clinicians assess tissue function and compromised circulation by measuring oxygenation and hemoglobin levels in superficial tissue. The diagnostic information can be used in assessing, managing and treating several
Devices
FDA has approved Medtronic’s Implantable System for Remodulin for treating patients with pulmonary arterial hypertension (PAH). The device/drug collaboration leverages Medtronic’s SynchroMed II drug delivery system and cardiac catheter technologies to deliver United Therapeutics’ Remodulin (treprostinil) injection. United Therapeutics will lead the product’s promotion with Medtronic’
Devices
FDA has approved an Integer Holdings PMA for its radial access introducer RadialSeal. The device was designed using the company’s guidewires and hemostatic introducers. The company says it has optimal treatment flexibility provided by a thin walled sheath design that minimizes outer diameter while maximizing inner diameter, and ease
Devices
FDA says that using energy-based medical devices to perform vaginal rejuvenation, cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events. An agency safety communication says the safety and effectiveness of energy-based
Devices
FDA has cleared a Sekisui Diagnostics 510(k) for the Sekure HbA1c assay and its use as an aid in diagnosing diabetes mellitus. The device is also cleared as an aid in identification of patients at risk for developing of diabetes mellitus, and for monitoring long-term blood glucose control
Devices
FDA has cleared a Cepheid 510(k) for the Xpert Xpress Flu/RSV test, which can be performed in near-patient settings, providing rapid molecular detection of influenza A and B viruses, and respiratory syncytial virus from patient specimens within 20 minutes. In addition to nasopharyngeal swab specimens, the test
Devices
FDA has cleared a LifeSignals 510(k) for its wireless LP1100 Life Signal Patch that is intended for enabling the next generation of wearable, healthcare monitoring devices. It uses the company’s recently launched LC100 Life Signal Processor platform and a patented, integrated multi-electrode architecture, according to the company.
Devices
FDA has cleared an Adherium 510(k) for its Hailie sensor and its use with Teva’s ProAir HFA, and GlaxoSmithKline’s Ventolin HFA and Flovent HFA asthma inhalers. The device attaches to a patient’s asthma medication inhaler to monitor and promote adherence as part of a self-management
Devices
FDA has cleared a CarboFix 510(k) for the CarboClear Carbon Fiber Pedicle Screw System, a device intended to surgically treat oncological patients. The device is intended to restore the integrity of the spinal column in the absence of fusion for a limited time in patients with advanced-stage tumors
Drugs
Regulatory consulting firm Greenleaf Health has added former FDA field investigator Kristen Grumet as senior vice president for regulatory compliance. Grumet spent almost 10 years at the agency and focused on medical device compliance. She also has 16 years of quality systems compliance management and consulting within the device industry.
Devices
FDA has released a draft guidance entitled “Peripheral Vascular Atherectomy Devices — Premarket Notification [510(k)] Submissions.” The document says that atherectomy devices vary in design and complexity and there are currently four main categories. The choice of an atherectomy device depends on plaque location, vessel characteristics, length of disease segment,
Devices
The Justice Department says AngioDynamics will pay the U.S. $12.5 million to resolve allegations that it caused healthcare providers to submit false claims to Medicare, Medicaid, and other federal healthcare programs relating to use of its LC Bead and Perforator Vein Ablation Kit (PVAK) medical devices. A department
Devices
FDA has updated a 1/18 safety alert that warned health professionals about Zoll Medical’s Zoll LifeVest 4000 Wearable Cardioverter Defibrillator due to concerns that it may fail to deliver treatment if it is not replaced soon after displaying a “call for service” message code 102. Failure to contact
Devices
FDA released 7/25 an updated list of mobile medical applications that the agency has cleared or approved since 1997. The list contains nearly 300 entries and has links to listings in the 510(k) and PMA databases.
Devices
FDA has approved an Endomagnetics Inc. PMA for the Magtrace and Sentimag Magnetic Localization System, a device for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The device uses magnetic detection during sentinel lymph node biopsy procedures to identify specific (sentinel) lymph nodes for surgical removal, an
Devices
FDA has cleared a PerkinElmer 510(k) for its EuroImmun ANCA IFA and Europlus Granulocyte Mosaic assays and their use with the EuroPattern microscope. The assays are designed as indirect immunofluorescence tests for the qualitative or semi-quantitative determination of anti-neutrophil cytoplasmic antibodies ANCAof immunoglobulin class IgG in human
Devices
FDA says Ycellbio Medical Co., Seoul, South Korea, is selling its Y-PRP System (Ycellbio kit) without an approved PMA or IDE in place. A 7/10 Notice of Violation says that promotional materials claim that the kit “facilitates separating and harvesting ‘pure sources of concentrated platelets’” from “a small
Devices
FDA is reminding hearing aid manufacturers that until the effective date of a published final regulation, there are no products that can legally claim to be over-the-counter hearing aids within the definition included in section 709 of the FDA Reauthorization Act of 2017. An agency letter to manufacturers
Devices
FDA has granted Med-El USA de novo marketing for its Bonebridge bone conduction hearing implant system for individuals 12 years and older who have been diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness. The device comprises an internal BCI 601 implant, and a Samba audio