HeartSciences said today that its MyoVista high sensitivity electrocardiograph testing device won CE Mark and launched in Europe. The Westlake, Texas.-based company’s device measures the heart’s energy per heartbeat using Continuous Wavelet Transform, a type of advanced signal processing that provides doctors with a detailed visual description of a cardiac cycle’s energy distribution. Traditional resting […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Camber Spine wins FDA nod for Spira interbody fusion device
Camber Spine Technologies said today it won FDA 510(k) clearance from the FDA for its Spira open matrix anterior lumbar interbody fusion device. The Wayne, Penn.-based company said the Spira device consists of spiral support arches designed to increase fusion rates and stabilization. The company said the spiral support arches also decrease subsidence by load […]
Cook Medical recalls select Zenith Alpha endo grafts
The FDA today released information on a recall of Cook Medical’s Zenith Alpha thoracic endovascular graft designed for treating blunt traumatic aortic injury over issues with thrombus formation, classifying the recall as Class I. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use […]
Stryker wins FDA nod for Serrato pedicle screws
Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its Serrato pedicle screw, designed for use in the non-cervical spine as part of its Xia 3 spinal system. The Serrato pedicle screws feature enhanced serrated cutting flutes, a dual-thread pattern with increased leads for rapid insertion and a buttress thread locking mechanism designed to reduce […]
India institutes price caps for orthopedic knee implants
Updated to include comment from the Association of Indian Medical Device Industry. Indian regulators are capping prices of orthopedic knee implants as the country looks to lower the cost of medical devices. The country’s drug pricing authority said today that orthopedic implants in the country had unjustified, unreasonable and irrationally high trade margins, which led […]
Glytec lands another 510(k) clearance for diabetes management software
Glytec said today that it won a fourth 510(k) clearance from the FDA for its insulin titration software, eGlycemic Management System featuring Glucommander. The latest FDA nod applies to product enhancements derived from user feedback, the Waltham, Mass.-based company said, including a streamlined transition of inpatients from IV to subcutaneous therapy and more robust workflow capabilities. […]
BioStable Science & Engineering wins FDA nod for Haart 200 aortic annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said today it won FDA clearance for its Haart 200 aortic annuloplasty device, touting it as the 1st and only such device designed specifically for bicuspid aortic valve repairs. The Austin, Texas-based company’s Haart 200 aortic annuloplasty device is intended for valve repairs in patients with aortic valve insufficiency […]
Amneal Pharmaceuticals issues voluntary recall of lorazepam droppers
Amneal Pharmaceuticals said today that it is voluntarily recalling 13 lots of its oral lorazepam product due to a defect in the dosing dropper. In some cases, the dropper is printed with the dose markings in reverse order or has no dose markings at all, according to the Bridgewater, N.J.-based company. So far, no adverse events […]
FDA approves pivotal study of Vascular Dynamics MobiusHD high blood pressure device
Vascular Dynamics said today that the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension. MobiusHD is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors there. Mountain View, Calif.–based Vascular Dynamics said the 300-patient Calm 2 study is designed […]
Senseonics expects FDA panel to consider Eversense CGM clearance
Senseonics (NYSE:SENS) said it expects the FDA will convene a special panel as it considers the company’s implantable Eversense continuous glucose monitors. The clarity came during the company’s 2nd quarter earnings call last week, with CEO Tim Goodnow saying the company expected the federal watchdog to look to an advisory panel, similar to its actions with Dexcom‘s (NSDQ:DXCM) […]
ImpediMed shares rise on FDA nod for Sozo system
Australian medtech developer ImpediMed saw shares rise as much as 9.7% after it said it won FDA 510(k) clearance for its Sozo bioimpedance spectroscopy platform. The Sozo system is designed to non-invasively measure and monitor fluid status and body composition using the company’s L-Dex lateral lymphedema assessment system. “We are delighted to receive this FDA clearance […]