President Donald Trump is slated to approve legislation this week that will give terminally-ill patients access to experimental drugs that haven’t yet been cleared by the FDA. The “right-to-try” bill has sparked a great deal of controversy among policymakers and patient groups. While some, including the president, describe the effort as offering hope to patients […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
TransEnterix surges on expanded indications for Senhance robot-assisted surgery device
TransEnterix (NYSE:TRXC) said today that it won expanded indications from the FDA for its Senhance robot-assisted surgery device, which is now cleared for hernia and gallbladder procedures. The federal safety watchdog’s expanded 510(k) decision doubles the Research Triangle Park, N.C.-based company’s addressable market, president & CEO Todd Pope said in prepared remarks. “These expanded procedures are […]
Imagen Tech wins de novo clearance for OsteoDetect wrist fracture software
Intelligence-based medical imaging diagnostic group Imagen Technologies today won FDA de novo clearance for its OsteoDetect computer-aided diagnosis software designed to detect wrist fractures in adult patients. The New York-based company’s OsteoDetect software is designed to analyze wrist radiographs using machine learning algorithms to identify regions of distal radius fracturing during the review of posterior-anterior and medial-lateral […]
7 medtech stories we missed this week: May 25, 2018
From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance […]
Avinger wins FDA nod for next-gen Pantheris
Avinger (NSDQ:AVGR) said today it won FDA 510(k) clearance for its next-gen Pantheris lumivascular atherectomy system, which it touts as the first image-guided atherectomy device designed for treating peripheral artery disease. Redwood City, Calif.-based Avinger said the newly cleared Pantheris device features a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability […]
FDA: Abbott’s Heartmate 3 recall is Class I
The FDA today labeled a recall of Abbott‘s (NYSE:ABT) Heartmate 3 left ventricular assist devices over possible twisting and eventual occlusion of the outflow graft as Class I. A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death. The HeartMate 3 devices are being […]
FDA clears Zimmer Biomet’s 3D-printed titanium Zyston spinal implant
Zimmer Biomet (NYSE:ZBH) said yesterday it won FDA 510(k) clearance for its Zyston Strut open titanium interbody spacer system, touting it as the company’s first 3D-printed titanium spinal implant. The Zyston Strut open titanium system is a family of lumbar cages intended to enhance strength, graft capacity and visualization capabilities of interbody spacers in spinal fusion […]
FDA approves Abbott’s latest drug-eluting stent
Abbott (NYSE:ABT) said today that it won FDA approval for its Xience Sierra everolimus-eluting coronary stent. The company’s device features a thin profile, improved flexibility and longer lengths than previous stents. The device and delivery system were designed to help clinicians tackle complex cases, like those involving multiple or totally blocked vessels, according to Abbott. Get […]
Beta Bionics wins FDA nod for home-use trial of artificial pancreas tech
Beta Bionics said this week that it won FDA approval to start recruiting patients with Type I diabetes for home-use studies of its iLet bionic pancreas system. The trial is slated to test Novo Nordisk’s fast-acting insulin, Fiasp, with the company’s autonomous infusion pump in adults with Type I diabetes. The study will also evaluate […]
RenovoRx raises $7m for drug-device pancreatic cancer therapy
RenovoRx said today that it closed a $7 million tranche in a $10 million round to fund the development of its drug-device combination product designed to deliver chemotherapy directly to tumors in patients with locally advanced pancreatic cancer. The company’s round was led by Boston Scientific (NYSE:BSX) and joined by btov Partners, Astia Angels, Golden Seeds and others. […]
Inari Medical wins FDA 510(k) for FlowTriever
Inari Medical said today it won FDA 510(k) clearance for its FlowTriever stent retriever designed to treat pulmonary embolisms. The clearance came based upon results from the company’s Flare clinical study of the device, which examined data from 106 patients with acute pulmonary embolisms treated with the FlowTriever at 18 US sites, the Irvine, Calif.-based company […]