Devices
FDA has cleared a RapidAI 510(k) for Rapid RV/LV, a tool for physicians to quickly assess the ratio between the right ventricle (RV) and the left ventricle (LV), a key indicator of pulmonary embolism (PE) severity. “Automating this process will enable care teams to more quickly prioritize patients
Devices
The U.S. Supreme Court has declined to hear a Johnson & Johnson case that sought the high court’s review and reversal of a California Court of Appeal decision imposing $300 million in civil penalties on the company’s Ethicon unit for marketing its pelvic mesh product in the
Devices
FDA has published guidances relating to marketing clearances of diagnostic ultrasounds and 510(k) submissions for ultrasonic diathermy devices. The first guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, gives detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. FDA says that in addition to outlining
FDA Policy/General
FDA commissioner Robert Califf says the agency will be tackling the problem of misleading health information, which he views as a “leading cause of preventable death in America now.” Califf made the comment in a paper marking the first anniversary of his becoming the agency’s 25th commissioner. He said
Devices
FDA has cleared a Zephyrus Innovations 510(k) for its Aerojec 3ml safety syringe. The device contains an internal mechanism that retracts the needle inside the syringe after activation. “Activation of the syringe occurs when the forward plunger movement punctures the propellant gas cell inside the needle assembly and initiates
Devices
GE HealthCare is recalling (Class 1) its Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent uncontrolled detector movement. “First, there is a risk that the ball screw that serves as design mitigation for the suspended mass of the detector may fail,” a
Devices
FDA has granted Merit Medical Systems a breakthrough device designation for its Scout MD Surgical Guidance System. The localization device supports implantation of up to four unique reflector configurations within abnormal breast or other soft tissue to “enable surgeons to pinpoint tumor location in multiple dimensions for more precise excision,
Biologics
The FDA MCMi Program Update annual report describes the agency’s efforts to ensure that medical countermeasures (MCMs), such as drugs, vaccines, and diagnostic tests, are safe, effective, and secure as they protect the U.S. from chemical, biological, radiological, nuclear (CBRN), and emerging infectious disease threats. The report says
Devices
FDA has cleared a 510(k) submitted by Belgium-based Sunrise for its second generation at-home sleep apnea test that uses artificial intelligence (AI) to aid in diagnosing obstructive sleep apnea and sleep-related breathing disorders. The device is intended to measure sleep through the bio-signal of mandibular
Devices
AdvaMed says it appreciates that FDA has issued a draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection, to update a previous guidance to include medical devices. The association’s statement says FDA should: * highlight throughout the document that an establishment may provide a
Devices
A 6/22-7/6/22 FDA inspection at Wintech Medipro in Katy, TX, found multiple violations in the firm’s manufacturing of surgical masks for which it does not have an approved PMA or IDE in place. A just-released 11/16/22 Warning Letter says the masks have
Devices
FDA has cleared a Hyperfine 510(k) for its upgraded Swoop AI-powered software for use with the Swoop Portable MR Imaging System. The software is intended to improve the image quality of the “diffusion-weighting imaging (DWI) sequence with increases in its signal-to-noise ratio,” the company says.
Devices
Johnson & Johnson’s Ethicon unit has reached an almost $10 million settlement agreement with Kentucky over alleged deceptive marketing practices involving the company’s pelvic mesh surgical devices. Under the terms of the agreement, Ethicon agreed to pay Kentucky $9.9 million within 30 days. “Patients suffer when medical
Devices
FDA has issued an emergency use authorization for the Cepheid Xpert Mpox test for use in a point-of-care setting for detecting monkeypox. “Validation data (were) gathered through the National Institutes of Health (NIH) Independent Test Assessment Program established as a collaboration between the FDA and the NIH,” the
Drugs
A just-posted HHS “Covid-19 Public Health Emergency Transition Roadmap” says FDA and other agencies will continue to have “significant flexibilities and actions that will not be affected” as the Biden Administration transitions out of the current public health emergency in May (see earlier story). The roadmap says the
Drugs
Ropes & Gray attorneys say FDA will publish a notice in the Federal Register explaining the effect the HHS decision to terminate its Covid-19 public health emergency (PHE) on 5/11 will have on FDA guidances and enforcement policies. In an online post, the attorneys say that at the
Devices
FDA says the 12/19/22 GE Healthcare recall of its nuclear medicine system is Class 1. An agency notice says the company reported that a mitigation may not be correctly implemented, meaning that the detector could fail and lead to life-threatening bodily injury.
Devices
FDA has updated an ongoing safety communication on Philips Respironics ventilators, BiPAP machines, and CPAP machines to provide updated information about medical device reports (MDRs) that the agency received from 11/1/2022 to 12/31/2022. The devices have been associated with the breakdown or suspected breakdown of the
Devices
FDA has denied a petition filed in 2013 by Thomas Law Company on behalf of tort plaintiff Marteen Moore, who claimed injury caused by DuraSeal Spinal Sealant. The agency response says the device was approved via the PMA process and is indicated for use as an adjunct to sutured dural
Devices
FDA has granted an emergency use authorization for a new BD molecular diagnostic combination test for SARS-CoV-2 (Covid-19), influenza A and B, and respiratory syncytial virus (RSV). The company says the test will be used on its BD Max molecular diagnostic system. The test uses a single
Devices
AdvaMed and the Medical Device Manufacturers Association (MDMA) say there are ways FDA can improve the draft guidance on its Voluntary Malfunction Summary Reporting (VMSR) program for manufacturers. In its comment letter, AdvaMed says it appreciates the agency’s effort to establish a summary reporting program for medical device malfunctions
Devices
FDA has cleared a DiA Imaging Analysis 510(k) for its LVivo IQS, a new artificial intelligence-based vendor-neutral software that the company says enables ultrasound users to acquire high-quality, interpretable cardiac images that can be used to make better clinical heart assessments. The company says high-quality