Month: October 2018

Zeiss Gets Approval for ReLEx SMILE for Myopia Treatment for People with Astigmatism

Zeiss won FDA approval for its ReLEx SMILE product for performing myopia treatment on patients with astigmatism. The product is offered on the company’s VisuMax femtosecond laser system, allowing the creation of a lenticule inside the cornea and access incision in one step. The laser is used to create millions of “photodisruptions” within the targeted tissue, […]

Applied BioCode’s MDx-3000 Cleared for GI Pathogen Detection

Applied BioCode, a company based in Santa Fe Springs, California, landed FDA clearance for its BioCode MDx-3000 molecular system for testing for 17 common gastrointestinal pathogens, including bacteria, viruses, and parasites. Clearance was based in part on a multi-center clinical study involving over 1,500 samples. The device is intended for medium to high volume clinical and reference […]

Unique Nebulizer and Drug Combo Approved for MAC Lung Disease

PARI Pharma, a German manufacturer of aerosol delivery products, won FDA approval of its LAMIRA nebulizer along with Insmed‘s ARIKAYCE (amikacin liposome inhalation suspension) drug for treating lung infections caused by the mycobacterium avium complex (MAC), a group of bacteria that are difficult to treat in many patients. The approval of the drug is the first […]

Feed.fm Brings Music to Mobile Health with Launch of Health.fm: Interview with CEO Jeff Yasuda

Studies have shown that listening to music can have clinically-beneficial side effects from lowering cortisol hormone levels that cause stress and anxiety to correlating highly with verbal memory improvement in stroke patients when compared to patients not listening to music. Seeking to leverage its existing music expertise and enter the mobile health market is Feed.fm, […]