Devices
FDA has cleared a PhotoniCare 510(k) for its TOMi scope for non-invasive imaging of the middle ear. The device uses optical coherence tomography high-resolution depth imaging to determine the presence or absence of fluid in the middle ear and characterize the fluid type, the company says. It
Devices
FDA has cleared an Applied BioCode 510(k) for its BioCode Respiratory Pathogen Panel (RPP) for use on the BioCode MDx-3000 System. The RPP tests nasopharyngeal swabs for of the most common viruses and bacteria, including Influenza A and subtypes H1, H1N1 2009pdm and H3, Influenza B, respiratory syncytial
Devices
Cook Medical has recalled (Class 1) its CrossCath Support Catheters due to a manufacturing error which may cause the marker bands to dislodge. A recall notice says that the company has identified that an error occurred during manufacturing which may cause the radiopaque marker bands to be too loose or
Devices
Smiths Medical ASD has recalled its Medfusion 4000 Syringe Pumps due to malfunctioning alarms and potential therapy interruption. The company has become aware of a software issue in the most recently updated device firmware, version 1.7.0, that could potentially cause the low battery alarms to stop working, a
Devices
Chembio Diagnostics says it expects FDA approval in two months on its PMA for the DPP HIV-Syphilis System. The single-use, 15-minute screening test simultaneously detects antibodies to HIV Types 1 and 2 and the bacteria that causes syphilis, Treponema pallidum. It uses a 10 microliter sample of
Devices
Several stakeholders are asking FDA to clarify its revised draft guidance on clinical and patient decision support software (CDS). AdvaMed says it is encouraged that the guidance uses a risk-based framework as called for by the 21st Century Cures Act and welcomes the use of several items from the
Drugs
Washington Legal Foundation (WLF) says the HHS Office of Inspector General (OIG) should reverse its decision to exclude drug and medical device manufacturers from the protection of proposed anti-kickback statute safe harbors. In a 12/31/19 comment, WLF praised the OIG’s removal of regulatory barriers to care
Devices
Congress gave Christmas presents to medical device manufacturers and other healthcare sector interests with provisions included in the $1.4 trillion spending bill approved before the holidays. The Washington Post reports that the pharmaceutical industry won extended protections for certain patents, even as Congress refused to act on a Senate
Devices
LivaNova has recalled (Class 1) its VNS Therapy SenTiva Generator System due to an unintended reset error that causes the system to stop delivering therapy. An FDA recall notice says that if a device replacement is needed, there is a risk associated with additional surgery to replace the generator. The
Devices
FDA has published a guidance, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, to describe relevant information that should be included in test report summaries, test protocols, and complete test PMA applications, HDE applications, 510(k) submissions, IDE applications, and De Novo requests. For
Devices
Neovasc has submitted a PMA for its Neovasc Reducer for treating refractory angina. The device is intended to relieve angina symptoms by altering blood flow within the heart’s myocardium and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle, the company says. Placement of the
Drugs
FDA has issued a draft guidance, Bridging for Drug-Device and Biologic-Device Combination Products, with recommendations for approaching bridging in NDAs or BLAs for drug-device or biologic-device single entity or co-packaged combination products. The document covers: * bridging of information related to a combination product that employs
Devices
FDA has authorized the de novo marketing of Tandem Diabetes Care’s Control-IQ Technology, an interoperable automated glycemic controller device that adjusts insulin delivery by connecting to an alternate controller-enabled (ACE) insulin pump and integrated continuous glucose monitor (iCGM). “This is the first such controller that can be
Devices
FDA has cleared a Boston Scientific 510(k) for its Exalt Model D Single-Use Duodenoscope, which is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. Traditionally, duodenoscopes have been intended for use on multiple patients,
Devices
Futura Medical says it intends to pitch to FDA a medical device regulatory approval pathway for the placebo arm from the European erectile dysfunction (ED) Phase 3 study FM57 after the placebo arm outperformed the active study drug, MED2005 (nitroglycerine) gel. The placebo gel contained the company’s proprietary transdermal
Devices
FDA says it has qualified the IMAnalytics with MRIxViP1.5T/3.OT and BCLib extraction and evaluation tool through the Medical Device Development Tools (MDDT) program. An agency statement says this is the first computational modeling tool that can be used across a wide range of active implantable medical devices
Devices
FDA has authorized the de novo marketing of PerkinElmer’s GSP Neonatal Creatine Kinase-MM kit as an aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Newborn screening uses a small amount of blood from an infant’s
Devices
FDA has cleared a Cochlear Ltd. 510(k) for the Cochlear Osia 2 System, an active osseointegrated steady-state hearing implant. The device uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear (cochlea), the company says. “The
Devices
FDA has cleared an ImpediMed 510(k) for Sozo, intended for use as an aid in assessing protein calorie malnutrition. Previously, the device was cleared as an aid in the early detection of secondary lymphedema, and determining fluid status for patients living with heart failure. The expanded clearance permits Sozo
Drugs
FDA says 25 unapproved drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, TN have been recalled. In September, a federal court approved a consent decree (see story) against the firms for unlawfully distributing the products. Products that have been recalled include drugs
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) have written to acting FDA commissioner Brett Giroir asking for the status of proposed rules on over-the-counter hearing aids. In a 12/5 letter, Grassley and Warren note that President Donald Trump signed the Over-the-Counter Hearing
Devices
FDA has cleared an OrthoGrid Systems 510(k) for its application PhantomMSK Trauma for use in orthopedic surgery. The universal software platform is intended to work with all manufacturer devices across multiple procedures using fluoroscopic imaging to assist with implant, instrument and anatomic alignment, the company says. It has software