The FDA granted Boston Scientific Corp. (NYSE:BSX) approval for its anchoring device for the company’s spinal cord stimulator (SCS) implant system.
The Natick, Mass.-based medical device giant designed its new Clik Anchor with locking system to increase the speed with which surgeons place the Precision Plus SCS system’s leads — the wires through which pain-masking electrical pulses are delivered to the spine for chronic pain management.
The company plans to introduce the Clik at the American Academy of Pain Medicine Annual Meeting, which opens in Washington, D.C., the company said.
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.
- MASEP Infini wins FDA 510(k) clearance for non-invasive stereotactic neurosurgery technology
MASEP Infini landed 510(k) clearance from the FDA of its Infini gamma ray neurosurgery system with Independent Beam Switch Control with Programmable Arcs, automated collimator exchange and three-dimensional patient positioning, and MASEP Infini’s Rotary Focusing technology. Independent Beam Switch Control with Programmable Arcs allows for fine-tuning of dose distributions to address even the most challenging cases. Automated collimator exchange and three-dimensional patient positioning allow radiosurgery to be conducted without the need to interrupt procedures to manually exchange collimators or re-position patients, according to the company.
- Blue Cross and Blue Shield companies to cover SBi’s STAR ankle replacement
Small Bone Innovations Inc. reported that 38 of the 39 independent member companies of the BlueCross and BlueShield Association will reimburse for the company’s STAR Total Ankle Replacement system for an estimated 98.5 million insured in 49 states.
- TranS1 Inc. wins 510(k) clearance for AxiaLIF 1L+
TranS1 Inc. (NSDQ:TSON) announced the 510(k) clearance of the AxiaLIF 1L+ product line, an instrumentation and implant system for L5-S1 lumbar fusion. TSON shares were up about 35 percent and trading around $4.42 in mid-afternoon trading on the day the announcement was made.
- Cardiovascular Systems lands 510(k) clearance for Stealth 360° orbital PAD system
Cardiovascular Systems Inc. (NSDQ:CSII) received 510(k) marketing clearance from the FDA, and has begun a limited market release for the Stealth 360° orbital PAD System. The Stealth 360° treats peripheral arterial disease (PAD) and was designed to give physicians more control of device operation.
- LensAR laser system receives clearance for lens fragmentation and anterior capsulotomy in cataract surgery
LensAR Inc. announced that the company has received 510(k) clearance from the FDA for use of the LensAR Laser System for anterior capsulotomy and lens fragmentation during cataract surgery.
- Two-Level Mobi-C cervical artificial risc PMA submitted by LDR
LDR, a privately held medical device company offering spinal implants for both non-fusion and fusion applications, announced the March 11 submission of its two-level Mobi-C cervical artificial disc PMA application to the FDA. LDR is one of only two companies to have completed a two-level randomized IDE trial with two-year follow up, and is the first to submit its results.
- Fresenius’ patient safety organization gains certification by HHS
Fresenius Medical Care (NYSE:FMS), the world’s leading company devoted to renal therapy, said that the U.S. Agency for Healthcare Research and Quality officially recognized the company’s patient safety organization (PSO). The certification was granted by the U.S. Secretary of the Dept. of Health and Human Services. The purpose of a PSO is to establish a framework by which doctors and other health care providers may voluntarily report information to PSOs, on a privileged and confidential basis, to collect and analyze patient safety events.
- GenMark nets medical device manufacturing license for Carlsbad, Calif. plant
GenMark Diagnostics Inc. (NSDQ:GNMK) received notice from the California State Food and Drug Branch, that following a recent audit of its new Carlsbad facility, it has been issued with a medical device manufacturing license, enabling the company to manufacture and distribute all its existing and future products from this facility. All operations at its Pasadena facility, which had been the source of all manufacturing and distribution for the company, will cease at the end of March.
- New York approves the Quest Diagnostics’ ColoVantage colorectal cancer blood test
Quest Diagnostics Inc. (NYSE:DGX) announced that its ColoVantage test was approved by New York State’s Dept. of Health for testing on samples of patients in the state. It is believed to be the first molecular colorectal cancer detection method that employs a venal blood specimen to be approved by the state.
- Fujifilm applies for 510(K) clearance from the FDA for the Aspire HD FFDM system
Fujifilm Medical Systems U.S.A. Inc. submitted to the FDA its 510(k) application for marketing clearance of its new Aspire HD Full Field Digital Mammography (FFDM) system. As a result of the down-classification of FFDM technologies by the FDA, Aspire HD is expected to be cleared in the near future.
- ULURU Inc. files 510(k) application to expand Altrazeal’s label claim
ULURU Inc. (NYSE Amex:ULU) filed an abbreviated 510(k) application with the FDA to expand Altrazeal’s label claim to include the management and mitigation of pain. The principal data supporting this 510(k) application is a randomized clinical study comparing Altrazeal to Acquacel Ag in skin graft donor sites.
- Intralytix wins clearance for Phage-Based E. coli technology
Intralytix Inc. announced that it has received regulatory clearance from the Food and Drug Administration for its phage-based EcoShield food safety product, effective against E. coli O157:H7. Clearance came in the form of a “Food Contact Notification” or FCN, filed with the FDA specific for the use of EcoShield on red meat parts and trim intended to be ground. The FDA has designated the FCN clearance for this phage-based product as FCN No. 1018.