The FDA grants de novo clearance to Johnson & Johnson subsidiary Ethicon Endo-Surgery's Percutaneous Surgical Set; European resolutions post-breast implant scare raise eyebrows among device makers; FDA grants PMA to Medinol's Presillion coronary stent; Nephros lands 510(k) for Hemodiafiltration; Toshiba touts FDA clearance for Aquilion Prime 80 CT system; Theragenics scores FDA clearance for Market Galt valved tearaway introducer; Spectranetics wins FDA clearance for its GlideLight laser sheath; and more.
Ethicon's Percutaneous Surgical Set was cleared through the federal watchdog agency' de novo pathway, a review process for low-to-moderate-risk medical devices that aren't substantially equivalent to a product already on the market.
"Laparoscopic surgery reduces the size and number of incisions needed to perform certain surgical procedures," Christy Foreman, director of the Office of Device Evaluation in FDA's Center for Devices & Radiological Health, said in prepared remarks. "The Percutaneous Surgical Set provides a novel treatment option for performing this type of abdominal procedure."
The surgical set was cleared only for use during minimally invasive laparoscopic abdominal surgery, during which surgeons insert a camera and instruments through a small incision in the body.
The surgical set is the 4th device cleared under the de novo process this year, according to a press release.
JNJ shares were down 0.1% to $65.16 as of about noon today.
European resolutions post-breast implant scare raise eyebrows among device makers
European med-tech industry group Eucomed had "mixed feelings" about a series of resolutions introduced by European parliament members following the high-profile breast implant recall that may affect as many as 1 in 3 of the 30,000 women implanted with the recalled Poly Implant Prosthèse breast implants.
The device group was particularly wary of calls for a pre-market authorization system for Class II devices, given that regulations already require clinical data evaluation prior to marketing for all medical devices. Read more
FDA grants PMA to Medinol's Presillion coronary stent
Israel's Medinol Ltd won FDA pre-market approval for its cobalt-chromium Presillion catheter-based coronary stent.
Nephros lands 510(k) for Hemodiafiltration
River Edge, N.J.-based Nephros (OTC:NEPH) touted 510(k) clearance for its Hemodiafiltration system, designed as a complement to dialysis for patients with chronic renal failure. Read more
Toshiba touts FDA clearance for Aquilion Prime 80 CT system
Tustin, Calif.-based Toshiba America Medical Systems won FDA clearance for its Aquilion Prime 80 series, designed to produce high-quality clinical images while reducing radiation exposure.
Theragenics scores FDA clearance for Market Galt valved tearaway introducer
Buford, Ga.-based Theragenics announced FDA clearance for its Market Galt valved tearaway introducer, designed for vascular access for catheter placement. Read more
Spectranetics wins FDA clearance for its GlideLight laser sheath
Colorado Springs, Colo.-based Spectranetics touted FDA clearance for its next-generation GlideLight laser sheath for removal of cardiac leads. The company plans to launch a limited market release before a broader controlled launch. Read more
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