The FDA today issued a recall for select Monteris Medical NeuroBlate systems and laser delivery probes over issues with unexpected MRI-related heating and damage to the tip of the probe that could cause serious injuries. The federal watchdog labeled the recall as a Class I, its most serious class of recall, which indicates the potential […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Genentech’s pre-filled syringe for diabetic retinopathy wins FDA nod
Roche‘s (OTC:RHHBY) Genentech announced today that the FDA approved its 0.3-mg pre-filled syringe as a new way to administer Lucentis to diabetic retinopathy patients. The company’s drug is the only FDA-approved medicine indicated for the treatment of diabetic retinopathy. The 0.3-mg pre-filled syringe is the first device of its kind approved to deliver an anti-vascular endothelial growth […]
FDA to review pSivida’s ocular drug-delivery system
pSivida (NSDQ:PSDV) said yesterday that the FDA plans to review the company’s application for its drug-releasing ocular insert, Durasert. The product is designed to provide three years of treatment for patients with posterior segment uveitis. The U.S. regulatory agency is slated to decide whether or not to approve pSivida’s new drug application by Nov. 5. Get […]
Medical device startups: Here’s how you handle regulatory and reimbursement
The two “Rs” — regulatory and reimbursement — are critical elements of the environment in which a medical device product is developed. Bill Betten, Betten Systems Solutions This is the fourth in a series of articles that discusses the design of innovative products in the highly regulated medical environment. But the “environmental” factors of regulatory and reimbursement actually […]
FDA clears Edwards Lifesciences hypotension index software
Edwards Lifesciences (NYSE:EW) said today it won FDA de novo approval for its Acumen Hypotension Prediction Index software designed to address potential hypotension in surgical patients. The Irvine, Calif.-based company said it is engaging in a targeted launch of the system in the US following the approval, which clears the software as an adjunctive predictive cardiovascular […]
FDA tags closing Philips plant for mishandling adverse event reports
Updated to reflect that the FDA document was a Form 483, not a warning letter, and to include commentary from a Philips spokesperson. The FDA recently released a Form 483 it sent to Royal Philips (NYSE:PHG) over issues it found with a Cleveland, Ohio-based plant the company plans to close, citing numerous mishandled adverse event reports […]
Amazon lures ex-FDA chief health informatics officer for healthcare skunkworks
Amazon (NSDQ:AMZN) is continuing to build its healthcare team, this time picking up former FDA chief health informatics officer Taha Kass-Hout, according to a report from CNBC. Kass-Hout is slated to take up a business development role with Amazon’s Grand Challenge team, a moonshot technology program similar to Google‘s (NSDQ:GOOG) Google X lab, according to the […]
Exact Imaging wins CE Mark for FusionVu micro-ultrasound/MRI fusion application
Micro-ultrasound developer Exact Imaging said today it won CE Mark approval in the European Union for its Fusion Vu application designed for micro-ultrasound/MRI fusion-based targeted prostate biopsies. The newly cleared application allows urologists to perform either cognitive fusion via Cognitivie Assist or micro-ultrasound/MR fusion on a high resolution platform, which the company said provides the “highest real-time […]
UroViu wins FDA nod for disposable diagnostic cytoscope
UroViu said yesterday it won FDA 510(k) clearance for its Uro-V single-use diagnostic cytoscopic system designed to visually assess the urethra and urinary bladder in instances of suspected pathology or dysfunction. The Bellevue, Wash.-based company’s newly cleared Uro-V device is a self-contained single-use diagnostic cytoscope designed for female diagnostic cytoscopy. The system is designed to […]
7 medtech stories we missed this week: March 16, 2018
From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing […]
Philips wins FDA nod for ProxiDiagnost N90 radiography-fluoroscopy system
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its ProxiDiagnost N90 digital radiography-fluoroscopy system. The newly cleared system is designed to perform both nearby fluoroscopy and digital X-rays to support more efficient room utilization and improve workflows, the Amsterdam-based company said. Philips said that the ProxiDiagnost N90 is designed to provide enhanced, high-quality images […]