Regulatory

New Medical Device Regulations are inching forward with the latest draft proposals. Just because they’re happening doesn’t make them better though, as pointed out by industry body Eucomed as it reminds us what we’d be losing (and what we wouldn’t be gaining) by moving to a US PMA style system.

Z-Medica® has gained expanded CE indications for its QuikClot® Hemostatic Dressings. QuikClot® products are now indicated as an adjunct to manual pressure for the temporary control of moderate external bleeding from surgical wounds or cuts and lacerations during operative and postoperative care.

It’s a form of ultimate recycling, fat tissue removed using Andrew Technologies’ HydraSolve device now being FDA cleared for reinjection into the same patient.

TriReme has announced that its Japanese partner, Century Medical, Inc. (CMI), has received Shonin approval for the Glider™ PTCA catheter indicated for treating the stenotic portion of coronary arteries or bypass grafts to improve myocardial perfusion. Glider™ is the world’s only torqueable PTCA catheter and is designed to address challenging cases such as bifurcations and highly stenosed lesions.

Aspect Imaging has obtained clearance from US FDA for its M2 compact MRI system, developed for diagnostic imaging of the wrist. The company says its technology should deliver MR-based imaging at a fraction of the cost of existing clinical MRI systems.

InspireMD, Inc., the developer of the MGuard™ Embolic Protection Stent (EPS), has announced approval with conditions for its US FDA Investigational Device Exemption (IDE) application. This approval allows the company to initiate enrollment in the MASTER II IDE trial.

Covidien has voluntarily recalled certain Power Pac batteries for its Newport™ HT70 and HT70 Plus ventilators following customers reporting units alarming and switching to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.

Ventripoint’s right ventricle ultrasound assessment tool was hitherto only CE marked for use in patients with right ventricle-associated disease. Now it can be used in a wider patient cohort, so picking up patients with concomitant heart disease.

Shape memory orthopedic device company MedShape, Inc. has gained US FDA 510(k) clearance for its Eclipse™ Soft Tissue Anchor. The company says its polymer anchor, is designed to attach a tendon, ligament or soft tissue to bone better than screws and other rotational devices.

Consumer protection activist organisation, Consumers Union has urged the U.S. FDA today to adopt a proposed rule requiring metal hip implants to be reviewed through the agency’s premarket approval (PMA) process to prove that the devices are safe and effective.

Reposable instrument company Microline Surgical, Inc.,has received FDA 510(k) clearance for its MIS Flexible Ligating Shears, enabling surgeons to effectively cut and seal soft tissue. The flexible nature of the device promises new ways to utilize advanced energy across a wide range of transluminal and other advanced modes of surgical access.

Abbott has announced that the TECNIS® Toric 1-Piece intraocular lens has received U.S. FDA approval and is launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism.

Patient monitoring device company CAS Medical Systems, Inc., has received U.S. FDA 510(k) clearance for its next-generation FORE-SIGHT ELITE(TM) Absolute Tissue Oximeter, which it claims is more accurate than its predecessor.

MIS spinal implant company Medical Designs, LLC, has announced the launch of its recently FDA cleared SAMBA™ Screw System, indicated for sacroiliac joint fixation. The company aims to distribute its device through a network of independent reps and distributors.

A solid set of clinical data underpins FDAs decision to extend Endologix’s FDA approval to include so-called percutaneous endovascular repair (PEVAR) of triple AAAs. Seems the procedure is quicker, safer, less painful and requires fewer transfusions than EVAR.

CryoLife, Inc. has received U.S. FDA 510(k) clearance for its next generation HeRO (Hemodialysis Reliable Outflow) device. The HeRO device is the only subcutaneous AV access solution clinically proven to maintain long-term access for end-stage renal disease (ERSD) hemodialysis patients with central venous stenosis.