Devices
FDA has classified as Class 1 a recent Medtronic recall of its Cobalt/Crome implantable cardioverter defibrillators and resynchronization therapy defibrillators due to reports about devices with a short circuit protection alert resulting in reduced-energy electric shock delivery, instead of delivering a second phase of high voltage therapy. “A
Devices
FDA has cleared a Visibly 510(k) for its Visibly Digital Acuity Product (VDAP), an at-home digital vision testing platform for determining visual acuity. The on-demand, self-administered visual acuity test uses a combination of a touchscreen mobile device and computer connected to the internet, and it can
Devices
Attorney Keeley McCarty (SheppardMullin) says medical device manufacturers should be aware that the federal government is using False Claims Act prosecution to target manufacturers for off-label use of their devices, even where healthcare providers have decided the use is safe and effective. Writing in an online post, McCarty cites
Devices
The Sedgwick Recall Index says Quarter 2 recall events soared 34% to a two-year high from 200 events in the last quarter to 268 events in Q2. The document says the number of affected units dropped, however, by 96.8% to 10.1 million units, the lowest quarter in
Devices
FDA has updated a June recall notice to warn healthcare professionals not to use Guangdong Haiou Medical Apparatus Company’s Haiou Needle Retractable Safety 1 mL syringe with 23G 1-inch needle and the Haiou Needle Retractable Safety 1 mL syringe with 25G 1-inch needle due to the potential
Devices
FDA says that between 5/1 and 7/31 it has received more than 48,000 medical device reports (MDRs), including 44 reports of deaths, associated with polyester-based polyurethane (PE-PUR) sound abatement foam degradation in certain Philips Respironics ventilators and other medical devices. The agency’s 8/16
Devices
FDA has cleared a Preceptis Medical 510(k) for expanded indications for its Hummingbird Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. Previously cleared in children aged 6-24 months, the new labeling allows in-office procedures in all children six months and older. The company says
Devices
Attorney Brynn Stanley(Gardner Law) says medical device manufacturers should start planning and implementing the concepts found in an FDA April draft guidance on cybersecurity in both their products and within their quality management system. Writing in an online post, Stanley says that to be effective, cybersecurity needs to be
Devices
FDA has released a draft guidance entitled “Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations Premarket Notification (510(k)) Submissions.” The document provides labeling recommendations to reduce misuse associated with these devices, which has resulted in serious eye injuries. FDA believes the recommendations may help manufacturers develop labeling
Devices
FDA has published a final rule establishing a new regulatory category of over-the-counter (OTC) hearing aids so that consumers with perceived mild to moderate hearing impairment may purchase hearing aids directly from stores or online retailers without a medical examination, prescription, or fitting adjustment by an audiologist. An
Devices
FDA has published a guidance, Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices, updating a 2003 updated guidance. The latest document says the 2003 guidance described a mechanism for manufacturers to follow when applying an assay that was previously cleared based on performance characteristics when used with
Devices
Medtronic has recalled (Class 1) its Cobalt and Crome implantable cardioverter defibrillators because the devices have the potential for reduced shock energy (about 79% of programmed energy) during high-voltage therapy. The company says it has issued a software release to update the Cobalt and Crome implantable cardioverter defibrillators and
Devices
FDA has cleared a Dyad Medical 510(k) for its echocardiogram application called Echo:Prio. The device is part of the company’s Libby cardiac platform, which is intended to provide fast, data-driven image analysis of echocardiogram images. The cloud-based, artificial intelligence-powered platform also provides users an
Devices
Four Democrat U.S. senators are urging FDA to initiate a post market study of pulse oximeters and seeking information about the agency’s clearance process for pulse oximeters to ensure they are effective across racially diverse patients and consumers. In a letter to FDA commissioner Robert Califf, Elizabeth Warren
Devices
FDA says the Becton Dickinson 6/20 recall of intraosseous needle set kits, manual driver kits, and powered drivers is Class 1. An agency notice says the company recalled 2,207 drills and 34,355 needle sets that were distributed between 1/20/20 and 5/5/22. The notice
Devices
An FDA 8/11 safety communication regarding serial use of at-home Covid-19 antigen tests was based on recommendations from a study by the University of Massachusetts Chan Medical School. The university says the study results show that at-home antigen tests are more likely to detect Covid-19
Devices
FDA has cleared a ClearPoint Neuro 510(k) for its ClearPoint Maestro Brain Model, software for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MRI images. “The current version will enable reproducible analysis of patient data which will provide immediate value for our
Devices
Although the formal deadline has passed for submitting comments on an FDA discussion paper on strengthening cybersecurity practices with servicing of medical devices, Philips is providing additional comments to bolster the feedback it previously submitted. The company’s 8/4 letter gives additional information in response to three questions posed
Devices
FDA has given 510(k) clearance for the ReShape Lifesciences Gastro Intestinal Balloon Indicator calibration tube for use in gastric and bariatric surgical procedures. The company says the tubes are available in three sizes and will simplify gastric and bariatric procedures including laparoscopic sleeve gastrectomy, gastric bypass, and gastric banding.
Devices
FDA says the 7/12 Haimen Shangbang Laboratory Equipment Co. recall of 4,165,200 viral transport media containers that were distributed in the U.S. between 10/8/21 and 2/15/22 is Class 1. An agency notice says the company recalled the products because they were distributed
Devices
A 1/29-2/15 FDA inspection at Zyno Medical, Natick, MA, found Quality System Regulation violations in the firm’s manufacturing of infusion pumps and associated administration sets. A just-released 7/12 Warning Letter says specific violations were: * failing to adequately establish and maintain procedures for implementing corrective
Devices
FDA has cleared a Bodyport 510(k) for its biomarker platform Bodyport Cardiac Scale that is intended to assess measures of heart function and fluid status for people with fluid management conditions, such as heart failure and kidney disease. “Weight monitoring is currently the noninvasive standard of care for detecting