Devices
FDA has granted Orlucent a breakthrough device designation for the company’s Orlucent Skin Fluorescence Imaging System, a handheld point-of-care molecular-based device designed to identify and clinically assess the presence of biological tissue remodeling activity associated with the development of atypical moles in adults. “The Orlucent system
Devices
Abbott reports new data from its AVEIR dual-chamber (DR) i2i Investigational Device Exemption (IDE) study to assess what it describes as the world’s first dual-chamber leadless pacemaker, that met its three prespecified primary endpoints for safety and performance. The data have been submitted to FDA as part
Drugs
Rep. Chip Roy (R-TX) has reintroduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments" (RESULT) Act that would expedite FDA’s approval process for potentially lifesaving medicines by allowing “reciprocal approval” of drugs approved in other trusted nations. “The American people should not have to wait years and
Devices
FDA has updated its CDRH Portal to allow users to track the progress of pre-submissions. Device premarket submission types may be uploaded to the CDRH Portal at any stage of the review process, according to an agency notice. “Official correspondents do not need to send a physical cover letter
Devices
Abiomed has recalled (Class 1) its Impella 5.5 with SmartAssist catheter, an intravascular micro axial blood pump that supports a patient’s circulatory system. The recall was decided after the company experienced a “heightened complaint rate for purge leaks,” according to a recall notice. FDA says the problem was
Devices
The Justice Department has resolved civil claims requiring Zoll Medical to pay $400,000 for selling Chinese-made products to the federal government that were required by law to have been made in America. The FDA-investigated case resolves allegations that between 1/2019 and 11/2022 Zoll sold electrocardiogram
Devices
FDA has cleared a Beta Bionics 510(k) for the iLet ACE Pump and the iLet Dosing Decision Software for treating Type 1 diabetes in patients aged six years and older. “These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system
Devices
Draeger Medical has recalled its Seattle PAP Plus continuous positive airway pressure device and VentStar breathing components due to breathing circuit concerns. “Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces,” a recall notice says. FDA has determined
Drugs
Bipartisan legislation to use penalties paid by drug, cosmetic, supplement, and medical device companies to increase childhood cancer research has been introduced by Sens. Tim Kaine (D-VA), Jerry Moran (R-KS), and Mark Warner (D-VA). A version of the bill has also been introduced in the House by
Devices
An 8/22-9/8/2022 FDA inspection at Sea-Long Medical Systems in Waxahachie, TX, found Quality System Regulation and other issues in the firm’s manufacturing of several varieties of its Sea-Long Medical Treatment Hoods. A just-released 4/4 Warning Letter lists these Quality System violations:
Devices
A Minnesota federal judge has entered a $487 million judgment against Cameron-Ehlen Group, which does business as Precision Lens, for violations of the False Claims Act and Anti-Kickback Statute. The judgment stems from a jury finding earlier this year that the defendants violated the statutes by paying kickbacks
Devices
FDA has approved an expanded indication for Abbott spinal cord stimulation (SCS) devices — treating chronic back pain in those who have not had or are not eligible to receive back surgery. Previously, the devices were approved for treating intractable pain of the trunk and limbs. The expanded use was approved
Devices
Cordis has recalled (Class 1) its Angioguard RX/XP Emboli Capture Guidewire System due to device separation concerns. “There is a potential for separation of the Angioguard RX/XP delivery system and capture sheath,” a recall notice says, which could lead to an intra-procedural delay, unplanned percutaneous or surgical
Devices
Now that the Covid-19 public health emergency (PHE) is officially over, FDA is urging medical device makers to maintain the status quo regarding PHE-related authority that required companies to report situations that could lead to device shortages. That authority, Section 506J of the FD&C Act, required
Devices
FDA says the Cook Medical 4/7 recall of the Blue Rhino G2Multi Percutaneous Tracheostomy Introducer is Class 1. A notice says the company recalled 3,053 units following customer reports that the tracheostomy in the sets and trays was not making a secure connection with the 15mm cap and
Devices
FDA has cleared a Sibel Health 510(k) on the ANNE One platform for continuous neonatal and infant monitoring for newborns and infants aged up to two years. The device monitors physiological parameters, such as heart rate, respiratory rate, skin temperature, body temperature, apnea-hypopnea index, total sleep time, snoring,
Drugs
AdvaMed says it “strongly supports FDA’s efforts to provide recommendations regarding requirements in clinical investigations for when electronic systems, electronic records, and electronic signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.” The association’s comments responded to an FDA draft Q&A
Devices
An FDA update on the use of the Apyx Medical Renuvion/J-Plasma device for certain aesthetic procedures says the agency cleared the Renuvion APR handpiece for coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring on 4/27. The update says the labeling and training for the
Devices
FDA has cleared a Hubly Surgical 510(k) for the Hubly Drill and its use in making burr hole procedures safer and more efficient in any setting, according to Hubly. “A burr hole procedure is the prerequisite brain surgery for any time a physician needs to access the brain,” the
Devices
FDA has cleared a Cumulus Neuroscience 510(k) for its dry-sensor Cumulus EEG headset and its use for the remote acquisition, display, and storage of electroencephalograph (EEG) data. “The headset is available in four sizes and is easily self-applied in less than five minutes with guidance from the
Devices
Three Hyman, Phelps & McNamara staffers, a medical device regulation expert and two attorneys, say a recent FDA draft guidance on predetermined change control plans (PCCP) for artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSF) is intended to reduce the need for prior FDA authorization of
Devices
Cue Health has filed a de novo submission seeking permission to market its Cue RSV Molecular Test for at-home and point-of-care use for detecting respiratory syncytial virus. If granted, the test would be the first of its kind for use in people of all ages, the company