Mirabilis Medica said today it won CE Mark approval in the European Union and FDA investigational device exemption for its Mirabilis System designed to treat uterine fibroids. The Bothell, Wash.-based company’s Mirabilis system is designed to use ultrasound to both provide imaging and ablation during procedures to remove uterine fibroids, the company said. The device […]
Food & Drug Administration (FDA)
BioStable Science & Eng wins FDA nod for Haart 300 aortic annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said yesterday it won FDA 510(k) clearance for its Haart 300 aortic annuloplasty device. The Austin, Texas-based company touted the Haart 300 as the 1st commercially available internal annuloplasty device designed for aortic valve repair, expected to be available to select US heart centers this summer. “We are very grateful for […]
FDA green-lights Aegis Medical trial for Sierra ligation device
Aegis Medical Innovations said today it won FDA investigational device exemption approval to begin a clinical trial of its Sierra Ligation System designed for left atrial appendage closure. In the trial, Vancouver-based Aegis Medical aims to explore the safety and procedural success of the minimally invasive Sierra procedure in closing off the left atrial appendage in patients […]
FDA warns on lymphoma risk associated with breast implants
The FDA this month warned of an association between breast implants and the development anapestic large cell lymphoma. The federal watchdog warned that the rare T-cell lymphoma can develop following implants, based on data the agency, and other health and regulatory bodies worldwide, have been collecting since 2011. The exact number of cases “remains difficult […]
Medtronic wins FDA nod for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut Pro transcatheter aortic heart valve replacement designed for treating severe aortic stensosis. The newly cleared, next-gen CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based […]
InVivo submits 1st HDE module for neuro-spinal scaffold
InVivo Therapeutics (NSDQ:NVIV) said today it submitted its 1st nonclinical study module to the FDA as part of its humanitarian device exemption submission for its neuro-spinal scaffold. The neuro-spinal scaffold is designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting, the Cambridge, Mass.-based company said. The submission […]
Facing pressure from pharma, FDA delays off-label promotion rule
After pharmaceutical industry groups filed a petition against the FDA’s new off-label promotion rule, the federal watchdog agency said last week it would delay the rule’s implementation to March 19, 2018. The agency originally intended for the law to go into effect on March 21 this year. The rule would expand the evidence that the […]
Aerospace may have something to teach medtech about materials: Here’s how
QuesTek Innovations has used advanced computer modeling to produce innovative materials in the aerospace sector. Now it’s looking to recreate the same magic in the medical device space. Medical device developers typically turn to off-the-shelf materials and then design based on the properties of the materials. But does it have to be this way? What […]
ACC 2017: FDA warns on Abbott’s Absorb
The Absorb bioresorbable stent made by Abbott (NYSE:ABT) confers a higher risk of serious adverse events at 2 years compared with the company’s Xience drug-eluting stent, according to new data from a study that prompted the FDA to warn physicians on the risk. But the picture is clouded by new guidelines indicating the proper blood vessel […]
FDA clears Toshiba Medical’s Aplio i900 cardiovascular ultrasound
Canon‘s (NYSE:CAJ) Toshiba Medical subsidiary said today it won FDA 510(k) clearance for its Aplio i900 cardiovascular ultrasound system and launched the device in the US. The Tustin, Calif.-based medical subsidiary said the Aplio i900 is designed to allow clinicians to assess myocardial function or quantify complex valvular lesions with a greater depth and detail than previous […]
7 medtech stories we missed this week: March 17, 2017
The FDA awarded 510(k) clearance to a couple of medtech companies this week while others received tax breaks and incentives, including a local tax break for a $154 million Stryker R&D facility planned in Michigan. Here are 7 medtech stories we missed this week but thought were worth mentioning. 1. FirstRay wins FDA 510(k) clearance […]