TransEnterix (NYSE:TRXC) said today it filed an FDA 510(k) submission looking to expand the indications for its Senhance robotic surgical platform to include laparoscopic inguinal hernia and laparoscopic cholecystectomy surgeries. The Research Triangle Park, N.C.-based company said that with the additional indications, its Senhance system would be cleared for use in the most common abdominal surgeries in […]
Surgical
Icon Bioscience wins FDA nod for long-acting cataract surgery drug
Icon Bioscience said today that the FDA has approved its application for Dexycu, a long-acting therapy designed to treat inflammation in patients who have had cataract surgery. More than four million cataract surgeries are performed each year in the U.S., according to the privately-held biopharma company, and most patients treat inflammation in their eyes using medicated […]
Bard escapes hernia mesh lawsuit
Becton Dickinson & Co.‘s (NYSE:BDX) C.R. Bard (NYSE:BCR) and subsidiary Davol this week avoided a lawsuit over allegedly defective hernia meshes after an appellate panel reaffirmed a lower court’s dismissal. The lower court had dismissed the suit on the grounds that the operating physician in the case was informed of risks associated with the mesh, eliminating […]
Titan Medical pushes FDA submission back to 2019, looks to US stock market cross listing
Titan Medical (TSX:TMD) leadership today spoke on the future of the company and its Sport single-port robotic surgery platform, saying it expects to begin submission of clinical data in pursuit of FDA approval by 2019, up from a previously expected submission in late 2018, and that it is exploring eligibility for a cross listing on a […]
J&J’s Ethicon sues Intuitive Surgical over EndoWrist cutter-stapler
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon sued Intuitive Surgical (NSDQ:ISRG) last year, alleging that the robot-assisted surgery pioneer infringes a group of patents with the EndoWrist stapler it developed for its da Vinci platform. The June 30, 2017, lawsuit asserts that the EndoWrist violates seven Ethicon patents covering its Echelon Flex line of endocutters and staplers, […]
Adhesys Medical wins FDA EAP designation for Vivo surgical sealant
The owner of Germany’s Adhesys Medical, Grünenthal, said today it won FDA expedited access pathway designation for its Vivo surgical sealant, designed to be an adjunct to standard closure techniques in gastrointestinal procedures to reduce intestinal leakage. The Germany-based company said that Vivo is a candidate from the company’s development-pipeline of surgical sealants. “We are delighted […]
Baxter posts Street-beating Q4 earnings, sales
Shares in Baxter (NYSE:BAX) fell slightly this morning after the company topped expectations on Wall Street with its fourth quarter and full-year results. The Deerfield, Ill.-based company swung to a loss in Q4 thanks to a $322 million hit from the recently-enacted U.S. tax reform legislation. Baxter posted -$71 million in net losses for the quarter on […]
Tryton Medical launches post-approval study of Side Branch Stent system
Tryton Medical said yesterday it launched a post-approval study of its Tryton Side Branch Stent system designed for treating coronary artery disease. The side-branch stent is designed to be compatible with any conventional drug-eluting stent in the main vessel, and comes in sizes ranging from 2.5mm to 3.5mm, the Durham, N.C.-based company said. “Greater than 20% […]
Ocular Therapeutix plans $32.5m public offering to fund NDA resubmission for Dextenza
Updated to include the offering’s pricing information. Ocular Therapeutix (NSDQ:OCUL) said today that it plans to launch an underwritten public offering of 6.5 million shares of common stock at $5.00 apiece to help fund the resubmission of its new drug application for Dextenza, an ocular post-surgical pain-relief implant that was rejected by the FDA last year. The Bedford, Mass.-based […]
Gecko Biomedical wins $7m French grant for tissue reconstruction tech
Gecko Biomedical said today that it won a French grant worth roughly $7 million has (€6 million) for the tissue reconstruction technology it’s developing. Paris-based Gecko said it plans to use the grant to commercialize its portfolio of synthetic light-activated polymers, which are designed to be biocompatible and bioresorbable and act as an adhesive, barrier or filler […]
Adhesys Medical wins CE Mark for Flix surgical adhesive
The owner of Germany’s Adhesys Medical said last week that it won CE Mark approval in the European Union for its Flix topical skin adhesive for surgery. Grünenthal, which in May 2016 inked a distribution deal with Adhesys, said it acquired Adhesys outright in April 2017. An internal surgical sealant based on the same polyurethane-based technology is […]