Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- Neovasc wins European approval for bovine tissue-based surgical patch
Neovasc Inc. (TSXV:NVC) received CE Mark approval for the use of its PeriPatch-BV bovine-derived biological tissue patches in surgical implantation procedures. PeriPatch-BV products, which are derived from pericardium tissue, are used in a variety of general surgical and cardiovascular applications, including the XenoSure product marketed by LeMaitre Vascular Inc. and as components in implantable heart valves and other medical devices. CE marking confirms that PeriPatch-BV pericardial tissue products conform to the applicable European Directive and allows them to be implanted in patients in all member states of the EU, the European Economic Area and Switzerland. The CE mark designation is expected to facilitate the approval of additional products in Europe that incorporate sterile and non-sterile PeriPatch-BV tissue as a sub-component, such as transcatheter heart valves.
- Access Scientific gains CE Mark for Powerwand
Access Scientific Inc. received CE Mark approval for the POWERWAND — a unique power-injectable, extended-dwell catheter. The company plans initial outside-US distribution of the device in Britain, Australia and South Africa. The POWERWAND, which is placed using the Accelerated Seldinger Technique, promises to improve the inpatient experience while increasing healthcare worker safety. The WAND’s proprietary technology is designed to make over-wire vascular access faster, safer and simpler. The device is designed to protect both patients and healthcare workers.
- Biomet’s Signature Personalized Patient Care System for Total Knee Replacement Receives 510(k) Clearance from the U.S. Food and Drug Administration
Biomet announced today that the FDA granted 510(k) clearance for the company’s Signature Personalized Patient Care System in the U.S. The Signature system provides patient-matched guides for use in total knee replacement surgery paired with Biomet implants, combining MRI or CT images for each patient with advanced surgical planning software and manufacturing techniques. The FDA granted the 510(k) clearance in a letter sent to Materialise NV, the manufacturer of the Signature system. At Biomet’s request, Materialise sought the 510(k) clearance to resolve the issues the FDA raised in a warning letter sent to Biomet on last July.
- EOS imaging receives additional FDA clearance of its sterEOS workstation for 3D orthopedic imaging of lower limb disorders and deformities
EOS imaging received FDA clearance of its sterEOS 3D orthopedic imaging workstation for use in lower limbs applications for patients 15 years and older. For decades, radiologists, orthopaedic surgeons and rheumatologists have had to rely on a set of 2D x-ray images to help them imagine what a 3D skeletal image of their patient would look like. Now, the EOS workstation sterEOS can create a 3D rendering of a patient’s skeletal anatomy.
- Rcadia COR analyzer system wins expanded FDA clearance to rule out artery disease in coronary branch vessels
Rcadia Medical Imaging received Food & Drug Administration 510(k) clearance for an enhanced version of its COR Analyzer System to assess coronary branch vessels in addition to main coronary arteries in patients with suspected coronary artery disease (CAD). The clearance is the third for the COR Analyzer System, a unique clinical decision support tool that automatically detects significant (50 percent and over) stenotic lesions in coronary arteries from Coronary CT Angiography (cCTA) studies.