Devices
AdvaMed says it appreciates FDA efforts to develop proposed transition plans dealing with medical devices issued emergency use authorizations during the Covid-19 emergency and medical devices under Covid-19 enforcement policies. The company’s comment letter thanks FDA “for its commitment to help provide a clear transition process to
Devices
Medtronic says it appreciates FDA efforts to establish appropriate considerations for premarket submissions for medical devices with physiologic closed-loop control technology. Commenting on the agency’s 12/23/21 draft guidance on the topic, the company says it also appreciates the agency’s recognition of the value of computational
Devices
FDA has granted Noninvasix a breakthrough device designation for its LivOx Central Venous Oxygenation Monitor for real-time, continuous or spot monitoring of central venous oxygen saturation (ScvO2) in adults at risk of septic shock. “Measuring ScvO2 non-invasively will open new paths to more efficient and earlier diagnosis of
Devices
Baxter International has issued an urgent safety communication to highlight important information on the device’s upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps. “Incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication,
Devices
FDA has classified as Class 1 a recall of the E25Bio Covid-19 Direct Antigen Rapid Test. “This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by
Devices
FDA is proposing to incorporate by reference in the Quality Management System the International Organization for Standardization ISO 13485, approved in 2016. A Federal Register notice says FDA has historically recognized the benefits of harmonization with other regulatory authorities and over time has acted to promote consistency with its regulatory
Devices
FDA says the 1/20 recall by BASE10 Genetics of its RNAstill MTM specimen collection kits is Class 1. The company is recalling the kits because they were distributed without proper premarket clearance from FDA. An agency notice says there are not enough data available about the product to know
Devices
CDRH should increase transparency by requiring more and better information on artificial intelligence (AI)-enabled tools in its approvals public database. “Currently, the details that companies publicly report about their products vary,” according to a post by Pew Charitable Trusts health care products director Liz Richardson. “For example, in an
Devices
FDA has granted Medtronic expanded indications for its Freezor and Freezor Xtra Cardiac Cryoablation Focal Catheters for treating pediatric atrioventricular nodal reentrant tachycardia (AVNRT), the most common form of supraventricular tachycardia (SVT). Almost 35% of AVNRT cases occur in children under the age of 18, the company says. “Due to
Devices
FDA says the 12/23/21 Vyaire Medical recall of some Bellavista 1000 and 1000e ventilators is Class 1. The company recalled 2,605 units that were distributed in the U.S. between 1/26/17 and 12/31/21 after reports of ventilators failing to ventilate and generating a
Devices
FDA has approved a PMA supplement application for an improved version of Avita Medical’s Recell autologous cell harvesting device system. The company says the revisions will give clinicians a more efficient user experience and simplified workflow. The Recell system enables healthcare professionals to produce a suspension of Spray-On-
Devices
FDA has cleared a Tandem Diabetes Care 510(k) for bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app. The company says this is the only FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems. “The
Drugs
Two Dechert attorneys say the 9/2021 FDA “intended use” regulation should not keep companies from manufacturing more of a drug or medical device than they would need to meet the anticipated demand for on-label prescriptions because it was aware of off-label uses. Writing in a Washington Legal
Devices
Aspen Tech Policy Hub fellow Daniel Bardenstein says FDA should require all medical device makers to include a baseline of certain cybersecurity protections in their products and to build in a feature that allows safe vulnerability scanning of their devices without disrupting their safe operation with patients. In an interview
Devices
FDA has cleared a Casio America 510(k) for the DZ-D100 DermoCamera and the DZ-S50 scope for skin observation by dermatologists. The devices were developed in collaboration with dermatology professionals and deliver both standard sized and close-up shots of an affected area with a single unit, according
Devices
FDA has cleared a Motus GI Holdings 510(k) for the Pure-Vu EVS System for colonoscopies. The device is intended to improve speed of set-up, enhance navigation capabilities in tortuous anatomy, improve cleansing capabilities and enable physicians to overcome the challenges of poorly prepared colons during a colonoscopy,
Devices
FDA has granted Datar Cancer Genetics a breakthrough device designation for its TriNetra-Prostate blood test to detect early-stage prostate cancer. The designation is based on studies showing that the test can detect early-stage cancer with high accuracy (greater than 99%) without any false positives, according to the
Devices
FDA has approved Senseonics Holdings’ next-generation Eversense E3 continuous glucose monitoring (CGM) system and its use for up to six months in diabetic patients aged 18 years and older. The device is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements
Devices
FDA has cleared an Esaote North America 510(k) for its Magnifico Open MRI, a whole-body MRI system intended to bridge the gap between traditional musculoskeletal imaging and whole-body imaging. It features the company’s True-Motion technology that provides real-time imaging solution of the joint, which
Devices
Some 11 senators, led by Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA), are calling on FDA to finalize its proposed rule on over-the-counter (OTC) hearing aids without delay. In a 2/8 letter, the senators say the public comment period on the proposal closed 1/
Devices
AdvaMed says an FDA discussion paper on 3D printing of medical devices at the point of care needs to include a “firm statement … that 3D printing of repair parts or remanufactured devices should fall within the auspices of this guidance.” The association comment letter says AdvaMed agrees with the FDA
Devices
The White House Office of Management and Budget (OMB) has completed its review of CDRH’s long-awaited proposed rule to modernize the medical device Quality System Regulation (QSR) by harmonizing and “supplanting” existing requirements with the specifications in the International Organization for Standardization’s (ISO) 13485:2016. OMB’s