FDA has slapped the most serious designation on a recall of approximately 156,957 Medtronic (NYSE:MDT) dual-chamber pacemakers. The Fridley, Minn.-based company issued a recall in January on pacemakers with model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron due to a software error that can result in a lack of pacing. Patients and physicians cannot predict whether and […]
Affluent Medical touts results of endovascular aneurysm repair study
Medtech startup Affluent Medical (Paris, France) said a study of its endovascular aneurysm repair (EVAR) system device showed patients had fewer endoleaks and needed fewer secondary interventions, and that their aneurysms shrank in volume and diameter. The company’s Kardiozis endovascular prosthesis uses thrombogenic fibers to embolize an abdominal aortic aneurism sac during a conventional EVAR procedure […]
NeoTract’s UroLift system gains expanded insurance coverage
Teleflex (NYSE:TFX) subsidiary NeoTract said that two more health insurers have agreed to offer coverage for the company’s UroLift system or patients with an enlarged prostate. The Wayne, Penn.-based subsidiary of Teleflex said that major U.S. insurer Humana and the Motion Picture Industry Pension & Health Plans (MPI), administered by Anthem Blue Cross, have added UroLift to its […]
Report: FDA panel wants more extensive data, quality of life outcomes for vaginal mesh products
Longer, more extensive studies and a focus on subjective quality of life outcomes were among the top agreed upon recommendations for future trials studying transvaginal mesh implants used for treating pelvic organ prolapse, according to a MedTech Dive report covering the recently held FDA transvaginal mesh advisory panel. While the panelists didn’t vote on any […]
Senseonics partners to provide veterans with Eversense CGM
Senseonics (NYSE:SENS) this week announced that it partnered with Geo-Med to provide access to the Eversense continuous glucose monitor to more than 9 million veterans and U.S. government staff. The company’s Eversense device is the first CGM system to feature an implantable sensor that can be worn for up to 90 days. Get the full story […]
FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures. In its letter, the federal watchdog also accuses the surgeon, Dr. […]
FTC wants more details on $4B Boston Scientific-BTG tie-up
The U.S. Federal Trade Commission wants more information about the proposed $4 billion tie-up of BTG (LON:BTG) and Boston Scientific (NYSE:BSX), but the companies said they still expect the merger to close on schedule in mid-2019. In a regulatory filing today, Marlborough, Mass.-based Boston Scientific said yesterday’s FTC request “is focused on the beads businesses of Boston Scientific and […]
Tandem wins interoperable claim for insulin pump from FDA
The FDA announced this week that it established Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump as the first in a new category of devices called ‘Alternate Controller Enabled Infusion Pumps’ or ACE pumps. The newly-approved indication for Tandem’s t:slim X2 pump clears the device to communicate with compatible products, including insulin dosing software and continuous glucose […]
Corindus asks FDA for expanded neurosurgery indication for CorPath GRX
Corindus Vascular Robotics (OTC:CVRS) said today that it submitted an application seeking FDA premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions. The Waltham, Mass.-based company has already received FDA clearance for percutaneous coronary interventions, which it won in 2016, and for peripheral vascular interventions, which it won last year. “The ability to […]
Wisc. Dem seeks co-sponsors for bill to repeal medical device tax
Rep. Ron Kind (D-Wis.) this week inked a letter to colleagues seeking support for a new bill that aims to repeal the medical device tax. The newly dubbed Protect Medical Innovation act of 2019 comes backed by Kind as well as Jacki Walorski (R-Ind.), Scott Peters (D-Calif.), Richard Hudson (R-N.C.), Terri Sewell (D-Ala.), Darin LaHood […]
Titan Medical hopeful for Q4 FDA IDE trial launch for Sport robotic platform
Robotic surgical platform developer Titan Medical (NSDQ:TMDI) said late yesterday that it is hoping to launch an FDA investigational device exemption trial of its Sport robotic surgery platform by the fourth quarter of this year. The news came as part of the Toronto-based company’s 2018 earnings report, with the robotic surgical company saying that it is hopeful […]
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