Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for the Vici peripheral venous stent it acquired when it bought Veniti last year. Marlborough, Mass.-based Boston Scientific said the FDA approved Vici for treating iliofemoral venous obstructive disease. The company inked a deal worth up to $160 million last August to acquire the […]
RenalytixAI wins breakthrough FDA nod for AI-powered kidney disease Dx
AI-powered kidney disease and transplant management diagnostic developer RenalytixAI said yesterday that it received an FDA breakthrough device designation for its KidneyIntelX artificial-intelligence powered diagnostic for kidney disease. The New York-based company touted the FDA clearance as the first ever for an AI-powered kidney disease diagnostic. The KidneyIntelX is designed to diagnose and improve clinical management of […]
Staar Surgical shares drop on FDA request for more data on EVO/EVO+ Visian lenses PMA bid
Staar Surgical (NSDQ:STAA) shares are down more than 10% after the company said it received a letter from the FDA’s Center for Devices and Radiological Health requesting more data for the premarket approval application supplement for its EVO/EVO+ Visian implantable collamer lenses for myopia and myopia with astigmatism. The federal watchdog said that the supplement lacked […]
FDA won’t ban textured breast implants
The FDA yesterday said it won’t ban textured breast implants, which may be linked to a type of immune system cancer, after one of its advisory panels said there’s not enough evidence to support the move. In March the federal safety watchdog’s General & Plastic Surgery Devices panel held two days of hearings before reaching […]
SentreHeart wins CE Mark, expanded indications for Lariat LAA devices
SentreHeart said today that it won CE Mark approval for its Lariat-RS 50mm and expanded labeling for the device for left atrial appendage exclusion. The Redwood City, Calif.-based company touted that its Lariat-RS device is different from other percutaneous LAA devices in Europe as it is the only non-implant solution for complete and permanent exclusion […]
FDA grants breakthrough nod to Concept Medical for MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of coronary in-stent restenosis. The device is cleared for treating patient’s who’ve experienced a re-narrowing of a stented coronary artery lesion due to subsequent tissue proliferation at the stented site, the Tampa, Fla.-based company […]
Report: FDA launches ‘Super Office’ in continuing shift to TPLC approach
The FDA Center for Devices and Radiological Health officially launched its new “super office”, the Office of Product Evaluation and Quality, on Wednesday, according to a report from the Regulatory Affairs Professionals Society. The newly launched division continues the federal watchdog’s shift to a total product lifecycle (TPLC) approach to regulatory oversight, covering premarket reviews, […]
FDA warns Surgisil for unapproved facial implant marketing
The FDA this week released a warning letter it sent to cosmetic device maker Surgisil over unapproved marketing of its Perma Facial Implant device. The letter follows an inspection of the company’s facilities in Plano, Texas, during which an FDA investigator determined that the company is marketing its Perma Facial Implant for indications outside of […]
Medtronic wins FDA nod for quadripolar Attain Stability left heart lead
Medtronic (NYSE:MDT) said today it won FDA approval for its Attain Stability quad MRI SureScan left heart lead, touting it as the only active-fixation left heart lead on the market. The newly cleared Attain Stability left heart leads are meant to be paired with the Fridley, Minn.-based company’s quadripolar cardiac resynchronization therapy-defibrillators and pacemakers, and feature […]
Imperative Care wins FDA nod for Zoom brain thrombectomy system
Imperative Care said today that it won FDA 510(k) for its Zoom aspiration system intended for removing clots during ischemic stroke. The Zoom aspiration system includes its Zoom reperfusion catheters, aspiration pump, canister and aspiration tubing, the Campbell, Calif.-based company said. The system is designed for use in revascularizing patients with acute ischemic stroke secondary […]
Implandata wins CE Mark for Eyemate eye pressur sensor
Implandata Ophthalmic Products said today it won CE Mark approval in the European Union for its Eyemate system intended for use in patients undergoing keratoprosthetsis surgery. The Eyemate device is designed to allow ophthalmologists to detect increase intraocular pressure so they can better manage patients’ conditions to reduce the risk of post-surgical complications and vision […]
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