The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts […]
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U.K., French regulators probe safety of paclitaxel devices
Taking a note from the FDA, U.K. and French regulators are investigating the safety of paclitaxel devices for the treatment of peripheral artery disease. Last week, the U.K. Medicines and Healthcare Products Agency said it ordered an inquiry into the safety of these devices following the publication of a meta-analysis that suggested a heightened risk of late […]
Intuitive Surgical wins another indication for da Vinci SP
Intuitive Surgical (NSDQ:ISRG) said today that it won another indication for the FDA for its da Vinci SP robot-assisted surgery device. Initially cleared in April 2014 for urological procedures, in June 2018 the federal safety watchdog added a clearance for procedures requiring very narrow access from a single small incision. Today the Sunnyvale, Calif.-based company said the FDA […]
FDA’s CDRH reorganization plans to launch next Monday
The FDA this week announced plans to reorganize its Center for Devices and Radiological Health, combining previously separate premarket review, postmarket surveillance and compliance offices and into one “super office” to better monitor products through their total product life cycle. The changes are slated to begin next Monday and are expected to be completed by […]
Abbott wins expanded indications for MitraClip
Updated to include commentary from Abbott The FDA today said that it granted Abbott (NYSE:ABT) a new indication for its MitraClip system, expanding coverage of the device to patients with normal mitral valves with diminished left heart function. The indication expands upon the original approval, which the Chicago-area medical device maker won in 2013, clearing it for […]
Biotronik wins FDA nod for Acticor, Rivacor high-voltage tachycardia devices
Biotronik said yesterday it won FDA approval for its Acticor and Rivacor high-voltage cardiac rhythm management devices intended for treating patients with cardiac arrhythmias. The clearance covers the Berlin, Germany based company’s Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX devices. “When determining the best treatment plan for […]
Fresenius wins FDA breakthrough device nod for fluid management software
Fresenius (NYSE:FMS) said yesterday that it won FDA breakthrough device designation for its computer-assisted ultrafiltration control software intended to improve fluid management during hemodialysis. The Waltham, Mass.-based company said that the software is designed to work with its newer hemodialysis machines using its CLiC device. Fresenius said that with the software, it hopes to create a […]
Xeris launches Ph2 trial of ready-to-use liquid glucagon
Xeris Pharmaceuticals (NSDQ:XERS) said today that it dosed the first patients in a Phase II trial of its ready-to-use liquid glucagon in people with Type 1 diabetes. The Chicago-based company expects to report top-line data from the study in the second half of 2019. Get the full story at our sister site, Drug Delivery Business News.
10 orthopedic products from AAOS 2019 you need to know
The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas is abuzz about robotics, according to industry analysts from SVB Leerink. While the SVB Leerink analysts termed Stryker’s (NYSE:SYK) Mako platform “best-in-class,” it’s an expanding category. Other major orthopedics companies are using this week’s AAOS meeting to introduce new offerings or tout updates to existing […]
Aerie wins FDA nod for second glaucoma drug
Aerie Pharmaceuticals (NSDQ:AERI) said this week that the FDA approved the company’s once-daily eye drop Rocklatan for the treatment of elevated intraocular pressure in people with open-angle glaucoma or ocular hypertension. The Durham, N.C.-based company’s product is a fixed-dose combination of latanoprost and netarsudil – the active ingredient in Aerie’s first drug, Rhopressa. Get the full […]
Stryker pays up to $220m for OrthoSpace
Stryker (NYSE:SYK) said today that it put $220 million on the table for OrthoSpace and its InSpace rotator cuff repair device. Stryker said it paid $110 million in up-front cash and agreed to another $110 million in potential milestones for the Caesarea, Israel-based company. “The acquisition of OrthoSpace is highly complementary to our existing portfolio […]