FDA approves low testosterone gel from Abbott | Regulatory roundup

April 30, 2011 By MassDevice staff Leave a Comment

Abbott Laboratories (NYSE:ABT) landed FDA approval for a new testosterone-boosting product.

The company’s AndroGel 1.62% is treatment for male low testosterone levels, also know as hypogonadism, which affects nearly 14 million men in the United States, according to the company.

"Low testosterone is a real concern for many men, and it is important that men exhibiting signs and symptoms talk to their doctor about appropriate testing and treatment," Dr. Natan Bar-Chama of New York’s Mount Sinai Hospital said in prepared remarks.

Abbott said the new colorless, odorless gel is an updated version of its AndroGel 1%, which requires more gel for the same treatment.

The company expects the new AndroGel to be available on the U.S. market before the end of May.

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.

STAAR Surgical wins CE Mark approval for nanoFLEX Collamer IOL
STAAR Surgical Company (NSDQ:STAA) announced CE Mark approval for its nanoFLEX Collamer Single Piece IOL which can be injected through a 2.2 mm incision with the nanoPOINT Injector System. The nanoFLEX IOL incorporates the company’s aspheric optic design, which is optimized for the naturally curved anatomy of the eye.
Read more

IDEV wins Australian approval for Supera Veritas
IDEV Technologies Inc. announced the firm has received approval from the Therapeutic Goods Administration (TGA), Australia’s regulatory agency for medical drugs and devices, for the SUPERA VERITAS stent system for use in biliary and peripheral procedures.
Read more

Maquet Cardiovascular wins 510(k) clearance for Cardiohelp
Maquet Cardiovascular announced that the FDA granted the company 510(k) clearance to market its CARDIOHELP System as a cardiac and/or respiratory assist device for up to six hours. The CARDIOHELP System is a portable heart-lung support system providing extracorporeal life support (ECLS) to replace or support a patient’s circulation and respiration. The product is expected to be commercially available in the U.S. later this year.
Read more

Quest Diagnostics wins CE Mark approval for Epstein Barr and BK Viruse test
Quest Diagnostics Inc. (NYSE:DGX) announced that two new Simplexa-branded molecular test kits developed by its Focus Diagnostics business were granted CE Mark approval. The test kits are designed to enable hospital labs to perform advanced molecular testing for Epstein-Barr (EBV) and BK viruses.
Read more

Mojo Vision developing ‘smart’ contact lens
Mojo Vision is working with the FDA to develop a smart contact lens to help people with low vision. The lens overlays real-time contrast and lighting enhancements with zoom functionality and recently won FDA breakthrough device designation. “Receiving the Breakthrough Device Designation is a significant step in our research and development process. We look forward to… […]
FDA to EPA: Leave us out of your ethylene oxide rule
This article has been updated with comments from the FDA. The FDA has asked the Environmental Protection Agency to leave the FDA out of its proposal for stricter regulation of ethylene oxide (EtO) emissions, and the EPA complied. In an interagency comment on the EPA’s proposed rule governing commercial EtO users — which includes medical… […]
Clippart debuts stepper-controlled flow valve
Clippard recently launched a new stepper-controlled proportional valve for precision flow control. The Eclipse valve uses the industry’s most robust and powerful miniature linear actuator, according to Cincinnati-based Clippard. The patent-pending Eclipse is designed for liquid and gas delivery, medical, analytical and industrial automation requiring ultra-fine resolution and repeatability. The design also allows for custom… […]
Supporting regulatory affairs departments to address clinical requirements under new MDR
By Dietmar Falke and Jaap Laufer, Emergo Group The May 25, 2020 MDR deadline is approaching rapidly, and by now many medical device manufacturers are aware that the MDR requires the proactive collection of post-marketing clinical follow-up (PMCF) data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog… […]
5 tips to raise funding for your medical device
Securing funding can be a long and tedious process, and medical device businesses must work to position themselves as especially attractive to potential investors to maximize success and accelerate the fundraising process. Jon Speer, Greenlight Guru According to Alejandro Cremades, author of The Art of Startup Fundraising, it can take from six to nine months… […]
FDA recognizes latest ISO 14971 as medical device consensus standard
By Mark Leimbeck and Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14071 risk management standard for medical devices and IVD products. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are… […]
Synaptive Medical updates Modus V surgical microscope
Synaptive Medical announced that its U.S. and Canadian Modus V robotic digital microscope now includes updates such as additional 3D visualization and voice-activated control. The Modus V is a robotically controlled digital microscope used as part of Synaptive’s BrightMatter surgical suite designed for less invasive, patient-specific approaches in complex cranial procedures. The Modus V provides similar… […]
New machine can preserve donor livers for 1 week
Researchers in Switzerland have built a perfusion machine that can preserve human livers for transplantation for a week or more, potentially slashing the number of donor livers that must be discarded due to time-related deterioration. Existing perfusion technology can preserve a donor liver for up to 24 hours. The team of surgeons, biologists and engineers… […]
Smiths Medical launches Portex tracheostomy tubes and kits
Smiths Medical this week launched its Portex polyvinyl chloride tracheostomy tube and kit portfolio. The new polyvinyl chloride (PVC) tube portfolio has options for a variety of patients, according to the company. “Our goal was to create tracheostomy tubes and kits designed to help clinicians provide the best patient care. We’re excited to offer a variety… […]
FDA clears Cleveland Clinic 3D-printed airway stents
The FDA recently cleared 3D-printed, patient-specific stents developed by a doctor at the Cleveland Clinic. Cleveland Clinic physician Tom Gildea developed the stents to keep open the airways of patients with serious breathing disorders caused by inflammation, trauma, tumors and other masses. Airway stents come in a limited number of sizes and shapes and are… […]
Boston Scientific shares drop on Q4 sales news
Shares in Boston Scientific (NYSE:BSX) dropped 8% this morning on news of disappointing fourth-quarter sales. The company’s preliminary earnings report showed sales for the quarter ended Dec. 31, 2019 coming in at $2.9 billion, below the $2.91 billion that analysts were expecting. The unaudited sales figure represents organic growth of 7.3%, missing the company’s own guidance of… […]