Devices
FDA says the Medtronic 4/11 recall of 1,614 HeartWare Ventricular Assist Device pump implant kits is Class 1. An agency notice says the affected devices were distributed between 10/11/06 and 6/3/21. Medtronic recalled the kits due to a pump weld defect. If the issue
Devices
Sens. Roger Marshall (R-KS) and Mike Braun (R-IN) have introduced S. 4349 to amend the Federal Food, Drug, and Cosmetic Act to add limitations on how notifications are made about potentially harmful medical devices. The bill says that any such notification should include a description of the applicable
Devices
FDA has posted information on how accreditation bodies can participate in the Accreditation Scheme for Conformity Assessment (ACSA) pilot to perform premarket testing for medical device companies. The post covers how to apply for ASCA recognition, FDA review of accreditation body applications, FDA engagement with ASCA-recognized accreditation bodies, maintaining
Devices
FDA says it is considering a master file pilot program for PMA holders whose approved devices are sterilized using radiation, including gamma radiation. An agency notice says the agency is considering such a pilot program due to global supply chain constraints and to support sterilization supply chain resiliency. “If implemented,
Devices
After more than 13 years at the FDA, CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein announced 6/3 that he left the agency for an undisclosed private sector job. Prior to spending almost six years as a regulatory advisor, Silverstein served as a Medical Device Reporting analyst and
Devices
CDRH director Jeff Shuren says as the Covid-19 health emergency subsides he hopes the Center can incorporate more regulatory flexibility, which was critical in getting numerous products to market during the public health emergency. He said this during an online FDA update about life after the pandemic and what
Devices
FDA has classified as Class 1 a Philips Respironics recall of all V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventilator to shut down unintentionally either with or without any visible or audible alarms. “The power fluctuation causes a reboot of the backup alarm controller,
Devices
FDA has released a final guidance entitled “Electromagnetic Compatibility (EMC)of Medical Devices” that offers the agency’s current thinking on recommended information that should be provided in a premarket submission to demonstrate EMC for electrically powered medical devices and medical devices with electrical or electronic functions. The document says
Devices
U.S. Senators Jacky Rosen (D-NV) and Todd Young (R-IN) have introduced their bipartisan Strengthening Cybersecurity for Medical Devices Act that would mandate FDA to review and update medical device cybersecurity guidelines and suggestions to ensure devices are protected from possible hacking and cyberattacks. Text of the legislation
Devices
FDA approved 5/25 the Apyx Renuvion dermal handpiece to be used with the company’s medical helium plasma generator for treating moderate to severe wrinkles and rhytides. A 6/2 updated agency safety communication says the new handpiece is limited to patients with Fitzpatrick skin types I, II, or
Devices
A 4/10 HHS Office of Inspector General (OIG) advisory opinion says a specific physician-owned distributor of a medical device is structured in such a way that it will not face anti-kickback sanctions. Writing in a Washington Legal Foundation Legal Pulse, three Goodwin Procter attorneys say the OIG
Devices
FDA says a cybersecurity vulnerability is affecting software in several Illumina next-generation sequencing instruments. An agency statement says the Illumina devices may be specified for either clinical diagnostic use in sequencing a person’s DNA or testing for various genetic conditions, or for research use only. The notice says
Devices
Atrium Medical has recalled its iCast Covered Stent System after receiving increased customer complaints about the balloon or catheter hub separating from the delivery system when it is being removed from a patient. “This issue seems to occur most often when the stent system is used outside of the indications
Devices
FDA has cleared a Stryker 510(k) for its Q Guidance System, which is intended to be used with the company’s spine guidance software, for advanced planning and intraoperative guidance during open or percutaneous computer-assisted surgery. The company says the software is the first to receive clearance for
Devices
FDA has granted in part and denied in part four Consumers for Dental Choice petitions submitted from 2015 to 2017 asking for additional warnings and labeling requirements for amalgam use in dentistry. The denial letter says two of the petitions asked FDA to warn against dental amalgam use in children,
Devices
CDRH says that as of 6/1 it plans to again accept all non-Covid in vitro diagnostic (IVD) pre-submissions. In an FDA Voices online post, CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say that due to the continued elevated workload related
Devices
Researchers from several Harvard University schools and departments and in other international institutions are suggesting the need for an amalgam of centralized and decentralized regulation of clinical artificial intelligence (AI). The researchers discuss the benefits and challenges of such an approach in a report in the open-source journal PLOS
Devices
FDA has cleared Abbott’s next-generation FreeStyle Libre 3 system for use by persons age 4 and older living with diabetes. The company says it is the most accurate 14-day continuous glucose monitor, with readings sent directly to a smartphone every minute. The company says the Libre 3
Devices
ArjoHuntleigh Polska has recalled its Sara Plus floor lift following several complaints of smoke or flames coming out of the lift. If the device’s battery is low, the device’s printed circuit board may overheat, resulting in smoke or fire, a recall notice says. “If this situation occurs, anyone
Devices
FDA has approved Medtronic’s In.Pact 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, indicated for the interventional treatment of peripheral arterial disease in the superficial femoral and popliteal arteries. The device is intended for de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm
Devices
FDA says an Abbott Medical 4/11 recall of 4,800 Dragonfly OpStar imaging catheters in the U.S. is Class 1. An agency statement says the company is recalling certain lots of the catheter because the marker band farthest from the catheter tip may become loose and, in two
Devices
FDA has approved ManaMed’s Class 2 ManaSport ultrasound therapy device that is labeled to provide pain relief and treatment for soft-tissue injuries. The company says the device can be prescribed by medical professionals and is intended for supervised use. It is said to provide non-invasive pulsed ultrasound