Devices
FDA says it is developing a general policy for the use of enforcement discretion for unauthorized tests in public health emergencies, which will be based on “lessons learned” from both the Covid-19 and monkeypox public health emergencies. The agency acknowledged the effort during a recent Government Accountability Office (GAO)
Devices
FDA has given 510(k) clearance to an Avatar Medical virtual reality surgical planning device. The company says it helps surgeons better prepare their procedures by using virtual reality representations of their patients. The patient avatars are generated instantly from CT scans or MRI images with an underlying proprietary technology,
Devices
FDA says it has determined that a cybersecurity vulnerability affecting the universal copy service software in several Illumina DNA sequencing instruments is considered a Class 2 recall, a situation in which using the device may cause serious adverse health consequences. An agency statement says the vulnerability was first announced in
Devices
Four Sidley Austin attorneys say FDA expects to issue in August a notice of proposed rulemaking to amend agency regulations to make explicit that laboratory-developed tests (LDTs) are medical devices under the Federal Food, Drug, and Cosmetic Act. In an online post, the attorneys say the agency decided to
Devices
CDRH says it is transitioning from paper export documents for medical devices to electronic export documents starting 1/2/2024. The documents that will be issued electronically include: * Certificate to Foreign Government, * Certificate of Exportability Section 801(e)(1) or 802, * Non-Clinical Research Use Only Certificate, * Certificate to Foreign
Devices
Outset Medical says FDA sent it a 7/5 Warning Letter with six observations from a 2/10 inspection involving the firm’s Tablo Hemodialysis System. Outset released the information in a Securities and Exchange Commission filing. The company says the letter does not request any restriction on the manufacture,
Devices
New York University researchers say there can be discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled devices, with some devices marketed as having such capabilities not approved by FDA for AI or ML. Writing in an online JAMA Network article, the
Devices
Teleflex has recalled (Class 1) its Slick Set Uncuffed Endotracheal Tube and Stylet Set (oral/nasal) due to reports about the 15mm connector disconnecting from the endotracheal tube. The company recently sent an “urgent medical device recall” notice to users that advised to stop using affected products and immediately quarantine
Devices
LumiraDx Ltd. has submitted a 510(k) to gain clearance for its five-minute Covid Ultra Test and the LumiraDx Instrument. LumiraDx had previously received various Emergency Use Authorizations for its Covid tests during the pandemic. “Once reviewed, this submission should facilitate further submissions to the FDA with focus switching
Devices
FDA says it has accepted the first master file for participation in the 510(k) Ethylene Oxide (EO) Sterility Change Master File Pilot Program. Under the program, 510(k) holders of devices labeled as sterile that want to begin using Andersen Sterilizers EO-Flexible Chamber Technology (EO-FCT) systems to
Devices
FDA has cleared two Roche assays that measure two biomarkers of Alzheimer's pathology — beta-amyloid and tau proteins — in adults over 55 being diagnosed with Alzheimer’s disease. The Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays “can detect Alzheimer’s
Devices
FDA has cleared a Cresilon 510(k) for Cresilon Hemostatic Gel to rapidly control bleeding without the need for manual pressure. The plant-based hydrogel works instantaneously to both stop and control bleeding at the point of care, according to the company. It is intended for the local management of
Devices
FDA has published a draft guidance, Patient-Matched Guides to Orthopedic Implants, with recommendations on information that should be included in regulatory submissions for patient-matched guides to orthopedic implants. The document also has recommendations that manufacturers should consider when developing their design process for this device type. “Patient-matched
Devices
FDA has issued a letter to healthcare providers to ensure they are aware of the current indications and instructions for use for the NuVasive Precice Intramedullary Limb Lengthening (IMLL) system, including Precice Short. An online update reminds providers that the IMLL device should be removed after one year. “Precice devices
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FDA has cleared a Candela 510(k) to expand the labeled indication of its Vbeam Pulsed Dye Laser for use of the 595 nm wavelength to include treating pediatric cutaneous capillary malformations, also known as port wine stains, and infantile hemangiomas/congenital hemangiomas. The company says port wine stains affect
Devices
FDA has cleared an Overjet 510(k) to expand the use of its artificial intelligence (AI) technology for predicting tooth decay in younger patients. The clearance covers the use of Overjet’s AI models for detecting and outlining caries (cavities) on periapical and bitewing radiographs for patients aged 12 years
Devices
Former DePuy Synthes sales representative Matthew Capobianco of Winchester, MA, was arrested 6/26 on eight counts of wire fraud and one count of making false statements in a case investigating his interference with a Boston-area hospital’s sterilization processes. A government indictment contends that from 1/2016 through
Devices
ReShape Lifesciences has filed a PMA supplement for the company’s next generation Lap-Band 2.0 for long-term treatment of obesity. Lap-Band is an alternative to more invasive surgical stapling procedures such as gastric bypass or sleeve gastrectomy, according to the company. The device uses a reservoir
Devices
FDA has cleared a CS Medical 510(k) for its Ethos Automated Ultrasound Probe Cleaner Disinfector for use in cleaning and high-level disinfection of endocavity and surface ultrasound probes. The device uses the company’s AquaCide cleaner disinfectant to clean and disinfect each ultrasound probe in about three minutes.
Devices
Centers for Medicare & Medicaid Services (CMS) has issued a proposed procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices. “The new Transitional Coverage for Emerging Technologies (TCET) pathway for Breakthrough Devices supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage
Devices
Arrow International has recalled (Class 1) its Arrow Endurance Extended Dwell Peripheral Catheter System due to the potential for catheter separation or leakage. Last month, Arrow/Teleflex sent customers an “urgent medical device recall” letter instructing them to immediately discontinue using and quarantine the products, according to a recall notice.
Devices
FDA has cleared an Owlet 510(k) for its BabySat, an at-home pulse-oximetry device for monitoring babies. The device, which features the company’s wire-free sock design, provides a real-time display of a baby’s pulse rate and oxygen saturation level (SpO2) and alerts parents when