Devices
Insulet Corp. has recalled its Omnipod 5 smartphone application and software that is used to control insulin pumps due to an error in the bolus calculator. An FDA recall notice says the calculator is not recording the decimal point if it is the first value entered when changing a bolus
Devices
FDA has cleared a Nanowear 510(k) for the company’s SimpleSense, a nanotechnology-enabled wearable and software platform. “As the first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic, SimpleSense-BP provides a transformational tool in clinical diagnostic management of hypertension and is additive to the wearable platform’
Devices
Rep. Gregory Murphy (R-NC), a practicing urologic surgeon and co-chair of the Congressional Doctors Caucus, is asking FDA for information on its approach to artificial intelligence (AI) in medicine and the tools and authorities it may need. In a 1/3 letter to FDA commissioner Robert Califf, Murphy
Devices
ROi CPS of Republic, MO, has recalled its Regard Wound Dressing change kit (Item Number 800026006) due to it containing nonconforming material/component. ROi CPS manufactured and distributed the medical convenience kits with an irrigation solution component that was subsequently recalled by the component manufacturer, according to a recall notice.
Devices
FDA has cleared a Siemens Healthineers 510(k) for the MAGNETOM Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner. The device offers the “strongest-ever gradient system for a clinically released whole-body MR scanner, making smaller structures in the body visible,” according to the company. It
Devices
FDA is updating an ongoing safety alert about reports of elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals from neonatal incubators. The agency says it has determined that new neonatal incubators by Drager (also known as Draeger) do not need to be run for a week before clinical use.
Biologics
FDA has issued a “ Draft Report and Plan on Best Practices for Guidance.” In the document, the agency identifies the best practices for the efficient prioritization, development, review, clearance, issuance, and use of guidance documents. The agency says it is also considering opportunities to further improve its guidance development and
Devices
FDA is alerting healthcare providers to not purchase or implant Synovo’s Total Hip System because modifications to the original device design were not cleared by the agency. “Three components of the system, the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing, have been significantly modified from
Devices
A 6/6-6/9/2023 FDA inspection at Terragene S.A. in Alvear, Santa Fe, Argentina, determined that the firm manufactures and distributes Biological and Chemical Sterilization Process Indicator Systems that are legally considered to be medical devices. A just-released 11/1/2023 Warning Letter cited these Quality
Devices
FDA says ResMed is conducting a voluntary field action to update its guides for all masks with magnets to inform users about potential magnetic interference when magnets are near certain implants and medical devices in the body. An agency announcement says the company’s masks are safe when used following
Devices
FDA says Medline Industries announced 12/20/23 a 10/10/23 recall of several lots of tracheostomy care and cleaning trays that include a tracheostomy brush that may have sharp edges at the tip that can puncture tubing during use and/or cause user injury during handling. An agency
Devices
FDA says a 6/26-8/2/2023 inspection at the Fresenius Medical Care Holdings facility in Waltham, MA, found Quality System regulation violations in the facility’s work as medical device specification developer responsible for complaint handling, recall management, and quality system oversight of the firm’s North American
Devices
FDA has approved AutoGenomics’ AvertD, the first test that uses DNA to assess whether certain individuals may have an increased risk of developing opioid use disorder. CDRH director Jeffrey Shuren says the AvertD test is intended to be used before the first exposure to oral opioid pain medications in patients
Devices
FDA has published a draft guidance, 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. The document says FDA may contract with third-party review organizations to perform reviews of emergency use authorization (EUA) requests when appropriate emergency declaration authorities are active. The guidance says
Devices
FDA says CDRH has begun issuing electronic export documents for medical devices. “The change from paper to electronic PDF improves efficiency in issuing export documents, reduces the amount of time it takes for a manufacturer to receive export documents, and decreases the environmental burden,” an agency notice says. The notice
Devices
A lengthy, deeply-researched KFF Health News report into its year-long investigation of FDA efforts to determine the safety and effectiveness of medical devices approved through the 510(k) pathway says they found “deep flaws” in FDA activities that resulted in “patient harm, exposed in lawsuits and records.” The
Devices
A 6/5-6/7/2023 FDA inspection at Sonesta Medical AB in Solna, Sweden, found Quality System Regulation violations in the firm’s manufacturing of a radiographic table and two cystometric tables. A just-released 9/22/2023 Warning Letter says the specific violations were failing to establish and
Devices
FDA has published a guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, with recommendations for sponsors, investigators, and other stakeholders on the use of digital health technologies (DHTs) for remote data acquisition. The document defines a DHT as a system that uses computing platforms, connectivity, software, and/
Devices
FDA has updated its “Risks and Complications of Breast Implants” Web page that clarifies information about implant removal and adds ultrasound as an acceptable alternative imaging device for screening for implant rupture for asymptomatic patients to the “Silicone Gel-Filled Implant Rupture” page. The agency also added a new subsection
Devices
FDA says it has begun participating in three new collaborative communities in the medical device ecosystem. An agency statement says a collaborative community is “a continuing forum in which private- and public-sector members, which can include FDA, work together on medical device challenges to achieve common objectives and outcomes.
Devices
FDA has approved an Abbott PMA for its automated GLP systems Track, which is intended to support high-volume laboratory needs and maximize productivity. The device features an “intelligent self-propelled single sample carrier – called CAR,” according to the company. “Samples move independently, not attached to rigid, fixed mechanized track
Devices
FDA has approved a Medtronic PMA for the PulseSelect Pulsed Field Ablation (PFA) System for treating both paroxysmal and persistent atrial fibrillation (AF). The company says this is the first PFA technology to receive FDA approval. Approval was based on data from the PULSED AF study, which showed a 0.