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.
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Neoprobe to submit cancer detection drug for FDA approval next quarter
Cancer diagnostics firm Neoprobe Corp. (NYSE Amex:NEOP) plans to file for U.S. regulatory approval of its cancer-tracing agent Lymphoseek next quarter.
CEO David Bupp confirmed on a conference call with investors that the Dublin, Ohio-based company during the second quarter would file a New Drug Application (NDA) with the with the Food & Drug Administration for the tracing agent.
FDA: Warning letter issued to JNJ’s stent making unit for Puerto Rican facility
The bad news continues to mount for Johnson & Johnson’s (NYSE:JNJ) cardiac stent-making arm Cordis Corp., which received an FDA warning letter about a manufacturing facility in Puerto Rico.
Medtronic home healthcare system cuts costs: Study | Research roundup
Medtronic Inc. (NYSE:MDT) said the results of a clinical trial for its new remote monitoring network indicate that the system reduces healthcare costs.
The study showed that monitoring of implantable cardiac device patients with the Medtronic’s CareLink network and CareAlert notification system cuts down on healthcare utilization costs when compared to in-office follow-up appointments, according to the company.
Is Medicare unsafe for Medtronic’s MRI-safe pacemaker?
Medtronic announced February 8 FDA approval of the Revo MRI SureScan pacing system, described as “the first and only pacemaker in the U.S. specifically designed for use in an Magnetic Resonance Imaging (MRI) environment.” In describing the impact of the new device, Medtronic estimated that 200,000 patients annually had to forego otherwise clinically appropriate MRIs because of the presence of a pacemaker.
Hospira lures Allergan president Michael Ball
Hospira Inc. (NYSE:HSP) ended its search for a CEO by luring Allergan Inc. (NYSE:AGN) president Michael Ball to the corner office in San Diego.
Ball, 55, replaces Hospira founder Christopher Begley, who’s staying on as executive chairman.
Ball spent 16 years at Allergan, rising to president after stints leading its pharmaceuticals , global eye care and North American businesses.
U.S. researchers grow, implant viable urethras
MASSDEVICE ON CALL — Researchers at Wake Forest University successfully grew and implanted urethras grown from samples taken from the patients’ own cells.
The MassDevice Weekly Checkup: March 8, 2011
Our Weekly Checkup takes the temperature of the medical device industry’s three largest U.S. clusters: Massachusetts, California and Minnesota.
The MassDevice Indices are weighted according to market capitalization, based on the number of shares outstanding for each company and each Friday’s closing share price.
The Massachusetts index for the week ended March 4 closed at 5.97, down 0.8 percent compared with the prior week. Since Jan. 1, 2009, when we began tracking these companies, the index has risen 34.7 percent.
MedGadget’s MedTech Monday: Second Sight wins CE Mark for retinal prosthesis
Second Sight wins CE Mark for retinal prosthesis: Sylmar, Calif.-based Second Sight Medical received European approval for its bionic eye system that can bring a modicum of sight to people with advanced retinal degenerative diseases. The Argus II system uses a head worn video camera to capture the scene, processes it by a computer, and sends a signal to an implant that stimulates the retina’s still functioning cells, according to the company.
Hip replacement recall: Yet another Johnson & Johnson implant lawsuit
Another lawsuit was added to the avalanche of litigation that DePuy Orthopaedics Inc. is facing over one of its hip implants, after a Tennessee woman sued the company over an allegedly faulty hip implant.
Kathern Hensley was implanted with a DePuy ASR XL Acetabular hip replacement system, according to a statement from the law firms representing the plaintiff.
OnPoint Medical hopes to overcome its incubator’s collapse
Health IT company OnPoint Medical Diagnostics Inc. could be the silver lining of the collapsed Minnesota incubator Healthcare IP Partners.
The organization fell to pieces in less than two years after trying to commercialize Mayo Clinic technology, such as the kind used by OnPoint.
Most of the incubator’s five spinoffs have uncertain futures.