Conavi medical said today it won FDA 510(k) clearance for its Foresight ICE System designed for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy. The device from Toronto-based Conavi, formerly known as Colibri Technologies, also allows for the visualization of other devices in the heart and great vessels of patients, the company […]
Food & Drug Administration (FDA)
CDRH lists strategic priorities through 2017
The FDA’s Center for Devices and Radiological Health this week released a list of its strategic priorities for the upcoming year. The federal agency’s top goals for the year include establishing a national evaluation system for medical devices, partnering with patients and promoting a culture of quality and organizational excellence, according to the report. The FDA […]
FDA warns ARB Medical on polymeric surgical meshes
The FDA this week released a warning letter it sent to ARB Medical concerning its production of polymeric surgical meshes. The agency knocked ARB Medical for marketing the product without appropriate clearance, and ran down a list of issues that arose after an inspection of its facilities in December. Included in the warning letter were […]
Medtronic buys Baylis Medical’s OsteoCool after FDA nod for spine cancer device
Medtronic (NYSE:MDT) said today that it acquired Baylis Medical’s OsteoCool device for treating cancers that metastasize to the spine after the device won 510(k) clearance from the FDA last year. The original OsteoCool device 1st won 510(k) clearance in March 2012. A 2nd version landed another 510(k) in June 2015, and Montreal-based Baylis won a nod last […]
Stryker pleural drainage device recall is Class I
The FDA this week labeled Stryker‘s (NYSE:SYK) Fuhrman & Pneumopericardial drainage set recall as Class I. The recall was issued over problems with the device breaking off in the pleural cavity during insertion. The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is […]
Senate panel OKs Califf for FDA commish
The U.S. Senate’s health panel today approved President Barack Obama’s nominee to lead the FDA, cardiologist Dr. Robert Califf, after members shrugged off criticism from consumer watchdogs about Califf’s ties to the pharmaceutical industry. The Senate’s Health, Education, Labor & Pensions Committee voted to confirm Califf, whom Obama nominated in September 2015. A cardiologist and longtime Duke University researcher, Califf joined […]
FDA approves LivaNova’s Perceval heart valve
The FDA approved the Perceval sutureless replacement heart valve made by LivaNova (NSDQ:LIVN) (the company formed by the union of Sorin and Cyberonics), the company said today. London-based LivaNova said it plans to begin commercial distribution of the Perceval valve, which is designed to replace the heart’s aortic valve using a self-anchoring frame. “We are excited to […]
FDA approves J&J’s Animas Vibe insulin pump & CGM for kids
Johnson & Johnson‘s (NYSE:JNJ) Animas Corporation subsidiary said today the FDA approved its Animas Vibe insulin pump and continuous glucose monitoring system for children and adolescents ages 2 to 17. The Animas Vibe system works with integrated Dexcom Inc. (NSDQ:DXCM) G4 platinum CMG technology and is the only system cleared for patients as young as […]
Astora lands FDA panel date for Topas incontinence device
The FDA today scheduled a panel date to discuss the premarket approval submission from Astora Women’s Health for its Topas incontinence device. The company and federal watchdog are slated to meet in late February to consider the company’s sling mesh device. The Topas is designed to be implanted around the puborectalis muscle for treating women […]
SRS Medical wins FDA nod for expanded study of Spanner prostate stent
SRS Medical Systems said it won the FDA’s approval for a clinical trial of its Spanner prostate stent for an expanded indication, a temporary implant designed to replace indwelling and intermittent urinary catheters. The Spanner device consists of a pair of anchors and a silicone tube and is designed to reduce resistance in the bladder neck and […]
FDA clears Integra’s Omnigraft for treating diabetic foot ulcers
Integra LifeSciences (NSDQ:IART) said today it won expanded FDA approval for its Omnigraft dermal regeneration matrix, now indicated to treat diabetic foot ulcers. The device, made of silicone, cow collagen and shark cartilage, is placed over the ulcer to provide a new environment for the skin and tissue to regenerate and heal the wound, according […]