Becton Dickinson (NYSE:BDX) said today that it won FDA 510(k) clearance for its WavelinQ 4 French endovascular arteriovenous fistula creation system. The Franklin Lakes, N.J.-based company said that the newly cleared WavelinQ 4F endoAVF system features improved technology that allows for the creation of an AVF in either the ulnar artery and ulnar vein or the radial […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
161m medical device units recalled in Q4 2018
The number of medical device units recalled in the fourth quarter of 2018 skyrocketed by 449% to 161 million from the same quarter a year ago, according to a report by Stericycle Expert Solutions. Those figures made it the second highest quarter for medtech units recalled since at least 2004. Medical device recalls fell by 1%, lower […]
Intrinsic Therapeutics wins PMA for Barricaid spinal implant despite safety concerns
Intrinsic Therapeutics has won FDA premarket approval for its Barricaid anular closure device intended for preventing reherniation, according to a recent FDA posting. The approval comes despite the fact that the prosthesis, which is designed for partial anulus replacement in patients with herniated discs, received a 5-8 advisory panel against recommending approval in December 2017. […]
Axonics seeks 1.5T MRI-safe clearance from FDA for r-SNM neuromod system
Axonics Modulation Technologies (NSDQ:AXNX) said today that it submitted an amendment to the FDA premarket approval application for its implantable r-SNM System 1 Sacral Neuromodulation device seeking full-body magnetic resonance imaging labeling. The amendment comes backed by complete test data which will support full body conditional labeling for 1.5 Tesla MR scanners, the Irvine, Calif.-based company […]
Touting pricetag, Mylan launches Advair generic
Mylan (NSDQ:MYL) today announced the launch of its Wixela Inhub product, a generic for GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus device, for people with asthma or chronic obstructive pulmonary disease. The company touted that its device’s list price is 70% less than Advair Diskus and 67% less than GSK’s generic. Get the full story at our sister site, Drug Delivery […]
Delcath wins approval for Chemosat in Brazil
Delcath Systems (OTC:DCTH) said today that it won medical device approval for its Chemosat hepatic delivery system from the national health authority in Brazil. The New York-based company plans to market and sell Chemosat in Brazil for the percutaneous intra-arterial administration of melphalan hydrochloride to the liver with subsequent extracorporeal filtration of blood. Get the full story […]
BioDirection wins FDA breakthrough designation for Tbit concussion detection system
BioDirection said today that it won an FDA breakthrough device designation for its Tbit point-of-care blood test for concussion diagnosis. The Boston-based company’s Tbit system is designed to rapidly detect and accurately measure protein biomarkers that are released from the brain following a head trauma. “We are pleased to receive this FDA designation and believe it […]
Regeneron touts one-year diabetic retinopathy data for Eylea
Regeneron Pharmaceuticals (NSDQ:REGN) touted one-year results from a Phase III trial of its Eylea aflibercept injection in people with moderately severe to severe non-proliferative diabetic retinopathy. The primary endpoint of the two-year Panorama trial is the proportion of patients who experience a two-step or greater improvement in the ‘diabetic retinopathy severity scale.’ Get the full story […]
Orthofix wins FDA PMA nod for M6-C artificial cervical disc
Orthofix (NSDQ:OFIX) said yesterday that it won FDA approval for its M6-C artificial cervical disc, intended for treating patients suffering from cervical disc degeneration. The Lewisville, Texas-based company said that the M6-C artificial cervical disc was developed by Spinal Kinetics, which it acquired last April. The newly cleared M6-C is a next-gen artificial disc intended to replace […]
Number of cancer cases linked to breast implants soars
FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths. The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017. FDA began reporting on cases […]
Pulmatrix wins FDA nod for PhII trial of inhaled anti-fungal therapy
Pulmatrix (NSDQ:PULM) said today that the FDA approved a Phase II trial of the company’s inhaled formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis in people with asthma. The Lexington, Mass.-based company plans to kick off the trial in the first half of 2019, with top-line data expected in the second […]