A study evaluating NeoTract’s UroLift treatment for men with enlarged prostate glands showed a 62% improvement in lower urinary tract symptoms, the company said today. The real-world study enrolled 100 men with benign prostatic hyperplasia (BPH) at a single center. Peak flow rate improved 140% and the post-void residual volume (PVR) decreased by 71 ml, with […]
Featured
Presbia plunges on one-year delay for Flexivue Microlens approval
Presbia (NSDQ:LENS) last week delayed the timeline for FDA approval of its Flexivue Microlens for treating far-sightedness after the federal safety watchdog said it wanted another year’s worth of data on the device. Irvine, Calif.-based Presbia submitted its final pre-market approval module to the FDA during the second quarter, including 24-month data for the Flexivue device, saying […]
Auris Health touts robotically-assisted bronchoscopy study results
Auris Health’s Monarch bronchoscopy platform reached lung nodules and biopsied tissue with “high accuracy” in a recent study, according to the company. Eight investigators performed robotic-assisted bronchoscopy procedures using the Monarch platform on a cadaveric model designed to mimic a real-life bronchoscopy procedure. Sixty-seven simulated tumor targets one to three centimeters in size were prepared […]
Tandem wins approval for insulin pump in Canada
Tandem Diabetes Care (NSDQ:TNDM) won a medical device license from Health Canada last week for its t:slim X2 insulin pump. The device integrates directly with Dexcom‘s (NSDQ:DXCM) G5 continuous glucose monitor and is the only system of its kind approved in Canada, according to the San Diego, Calif.-based company. Get the full story at our sister site, […]
Senators question basis for FDA’s digital health pre-cert pilot
Three Democratic senators representing major high tech and medtech hubs in the United States are questioning the statutory basis of FDA’s new pilot program for digital health product precertification. “We support FDA’s efforts to update the medical device review regime to better accommodate digital health devices and believe that it is an important step in ensuring that […]
Vital Therapies reduces board size, looks to explore sale or merger
Vital Therapies (NSDQ:VTL) said yesterday that it reduced its board size from nine to four, and that it has begun to explore ‘strategic opportunities’ including a possible sale or merger of the company. The San Diego-based company said it retained Ladenburg Thalmann & Co. as its strategic financial advisor to assist in “the review of the […]
Boston Scientific touts 3-year Solyx stress urinary incontinence mesh trial data
Boston Scientific (NYSE:BSX) this week released three-year data from a study of its Solyx single incision sling system intended to treat stress urinary incontinence, touting that the trial met all primary and secondary endpoints. Boston Scientific said it presented the full results from the trial yesterday at the annual scientific symposium of the American Urogynecologic Society. The […]
Varian acquires cloud-based oncology software dev Noona Healthcare
Varian Medical (NYSE:VAR) said today it acquired cloud-based, oncology-focused software developer Noona Healthcare for an undisclosed amount. Palo Alto, Calif.-based Varian said that Noona developed a cloud-based mobile service intended to capture cancer patient-reported outcomes. The system allows clinics to capture PROs and communicate with patients, the company added. “PROs represent a growing and significant metric […]
Report: Medtronic shuts down pacer programmer updates on hacking risk
Medtronic (NYSE:MDT) has disabled internet updates for approximately 34,000 CareLink devices designed for accessing and programming implanted pacemakers due to cybersecurity vulnerabilities with the systems, according to a Reuters report. The vulnerability, revealed this summer by cybersecurity firm researchers, could allow an outside agent to plant malware on the pacers that would allow them to […]
Canada clears Medtronic’s MiniMed 670G insulin pump
Medtronic‘s (NYSE:MDT) Canada subsidiary said today that it won a license from Health Canada for its MiniMed 670G insulin pump system. The insulin pump system is the first device in Canada that stabilizes glucose levels by automatically adjusting basal insulin delivery according to a user’s real-time needs, the medtech titan touted. Get the full story […]
TransEnterix wins FDA nod for 3mm instrument set
TransEnterix (NYSE:TRXC) said today that it won 510(k) clearance from the FDA for a 3mm-diameter instrument set for its Senhance robot-assisted surgery device. The federal safety watchdog also OK’d additional 5mm-diameter instruments, the Research Triangle Park, N.C.-based company said. The 3mm instrument open up micro-laparoscopic “virtually scarless” procedures for Senhance, according to TransEnterix. “The ability to […]
