Devices
FDA has cleared an Imperative Care 510(k) for its line of neurovascular access catheters, which are intended to deliver interventional treatments during neurovascular procedures for aneurysms, stroke and other brain blood vessel conditions. The devices are designed to “enable smooth, consistent navigation deep into blood vessels of the brain,
Devices
FDA has issued a guidance, Safety and Performance Based Pathway, with the agency’s current thinking on expanding the concept of the abbreviated 510(k) program for demonstrating substantial equivalence for 510(k) submissions. The document’s intent is to describe an optional pathway (the Safety and Performance Based Pathway)
Devices
FDA has cleared a 23andMe 510(k) for the MUTYH-Associated Polyposis report, a genetic health risk report on a hereditary colorectal cancer syndrome. The report follows a 3/18 clearance for the company’s BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report on the same ancestry and health service
Devices
FDA has classified as Class 1 a Medtronic recall of its Synergy Cranial Software and Stealth Station S7 Cranial Software due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm. The software is used with the company’s StealthStation Surgical
Devices
FDA has cleared an EBM Technologies 510(k) for its iPad Pro-based Rad System for diagnostic reading of radiological images. The clearance is intended to untether physicians from traditional fixed workstations and paving the way for greater work flexibility and financial efficiencies. Users download images by connecting iPad lightning
Devices
FDA says it is evaluating recent information regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral arterial disease (PAD) in the femoropopliteal artery. “A recent meta-analysis of randomized trials published in the Journal of the American Heart
Devices
FDA has accepted for review a Genentech supplemental BLA for Tecentriq (atezolizumab) in combination with Celgene’s Abraxane (albumin-bound paclitaxel; nab-paclitaxel) and carboplatin for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic
Drugs
Medtronic says it has enrolled the first patient in its Embrace TDD (targeted drug delivery) study to evaluate using the SynchroMed II intrathecal drug delivery system as an alternative to oral opioids for patients with chronic intractable non-malignant primary back pain, with or without leg pain. The company says
Drugs
FDA has released a final guidance, Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices, to assist drug or medical device sponsors who are planning to develop new drugs and test devices and want to coordinate development of the products so that the test device could be cleared either
Devices
As part of an agreement to resolve all long-standing patent disputes between the two companies, Edwards Lifesciences is making a one-time payment of $180 million to Boston Scientific. The two firms have been involved for several years in litigation over heart valve replacement systems, including transcatheter aortic valves,
Devices
FDA has cleared an Immuno Concepts 510(k) for the Histofluor Rodent LKS Tissue Slides for manual and Image Navigator use. The indirect immunofluorescent test is used to detect anti-mitochondrial antibodies, anti-smooth muscle antibodies, and anti-parietal cell antibodies. These autoantibodies are associated with several autoimmune diseases, including
Devices
FDA has cleared an MIM Software Inc. 510(k) for its molecular radiotherapy (MRT) dosimetry. MRT uses radiopharmaceuticals such as Lutathera (Lu-177 DOTATATE) and Azedra (I-131 iobenguane) to target tumors based on certain receptors that these tumors express. Currently, the company says there has not been an effective
Devices
FDA has cleared an iSchemaView 510(k) for its RAPID neuroimaging platform for use in selecting stroke patients who are likely to benefit from endovascular thrombectomy (clot removal). The additional clearance allows RAPID CT-Perfusion and RAPID MR-Perfusion to be used by physicians to aid in the selection of
Devices
AdvaMed says it has updated its Code of Ethics on Interactions with Health Care Professionals to “reflect evolving legal standards, care delivery models, and best practices over the last decade to ensure the code’s continued effectiveness as a premier foundational document for ethics and compliance.” An association announcement says
Devices
FDA has approved an Abbott PMA for the Amplatzer Piccolo Occluder, a tiny medical device that can be implanted in the smallest babies (weighing as little as two pounds) to treat patent ductus arteriosus, or PDA. The device, which is smaller than a pea, is intended for premature infants and
Devices
FDA has cleared an RFPi Inc. 510(k) for its iCertainty open surgery blood flow and perfusion imaging medical device, which is intended to show real-time blood flow and perfusion in vascular structures and critical tissues during surgeries. The company says iCertainty does not require injections, dyes, radiation, direct
Devices
During the current government shutdown, FDA says it is continuing to conduct device post-market surveillance. In a series of Twitter posts, FDA commissioner Scott Gottlieb sought to reassure constituents, saying that “while it’s not business as usual at the agency, we are continuing to prioritize our device safety
Devices
The 11th Circuit Court of Appeals has affirmed the sentence approved by a Florida federal court jury for a former Ethicon employee accused of stealing and reselling prescription medical devices on the grey market. The jury had sentenced Kerri Kaley, who formerly supervised sales representatives for Ethicon, to 36 months
Devices
SightGlass Vision, a medical device company developing spectacle lenses to slow the progression of nearsightedness or myopia in children, has been given an FDA green light to begin a pivotal clinical trial called CYPRESS. The study will evaluate the safety and efficacy of the company’s novel lenses compared to
Drugs
Hyman, Phelps & McNamara has released its annual report highlighting leading cases and settlements from 2018 affecting FDA- and DEA-regulated industries. The report provides a concise summary of the relevant facts and key takeaways of each case and also has a list of “hot-button” cases being monitored this
Devices
FDA has approved Grifols’ Erytra Eflexis, a benchtop analyzer that performs pretransfusion compatibility testing. The device uses DG Gel technology. “Interchangeable sample and reagent linear racks allow easy, continuous loading of cards, reagents and samples,” the company says. It features “real random access with a capacity of up to 200
Devices
FDA has granted RadioMedix a fast track designation for its investigational diagnostic radiopharmaceutical, [64] Cu-Dotatate, a positron emission tomography (PET) diagnostic agent being studied for somatostatin receptor expressing neuroendocrine tumors. RadioMedix says it has completed a Phase 3 clinical trial of the agent and expects to file an NDA