The US Food and Drug Administration (FDA) has granted 510(k) clearance to Dallen Medical's Compressyn Staple, designed for use in rigid small bone fixation, specifically in foot, ankle, and hand applications. Using the company's patented ...
Exact Sciences has submitted the second module of premarket application (PMA) of its noninvasive stool DNA colorectal cancer screening test to the US Food and Drug Administration (FDA). The module included the required studies and ...
Tags: FDA, colorectal cancer, clinical trial
Dako, an Agilent Technologies Company, has launched instant quality in situ hybridization (IQISH) technology in the US, to lessen cancer evaluation turnaround time. IQISH technology, based on Dako's fast IQISH hybridization buffer ...
Tags: IQISH technology, cancer evaluation, cancer treatments
The USFDA has granted priority review designation to ViiV Healthcare's dolutegravir as a candidate with the potential to treat HIV infection in combination with other antiretroviral agents, in adolescents and adults. The dolutegravir new ...
Tags: infection therapy, Healthcare, FDA
The USFDA has approved Novartis Zortress as the first drug to prevent organ rejection in adult patients receiving liver transplantation in the US. The approval was based on positive data from liver transplant study that compared Zortress ...
Tags: medication, FDA, Zortress
The US Food and Drug Administration (FDA) has cleared Second Sight Medical Products' retinal prosthesis system to treat patients with late stage retinitis pigmentosa (RP). The CE-marked Argus II retinal prosthesis system, which the ...
The US Food and Drug Administration (FDA) has approved labeling changes to Bristol-Myers Squibb's Reyataz (atazanavir), an antiretroviral medication. The label will now include warnings about kidney and gall stones in addition to updated ...
Specialty biopharmaceutical company Santarus has announced the commercial launch of ulcerative colitis therapy, Uceris (budesonide) extended release tablets. Uceris that contains a locally acting glucocorticosteroid, budesonide, in a ...
Tags: Santarus, Uceris, ulcerative colitis therapy
The USFDA has issued final approval to manufacture and market Aurobindo Pharma's diabetes drugs, Pioglitazone tablets and Pioglitazone Hydrochloride + Metformin Hydrochloride tablets. Pioglitazone Tablets USP 15mg, 30mg & 45mg and ...
Tags: USFDA, Aurobindo Pharma, diabetes drugs
The USFDA has approved Teva Pharmaceutical Industries' abbreviated new drug application (ANDA) for generic Adderall XR capsules to treat attention deficit hyperactivity disorder. The ANDA is concerned with generic version of Shire's ...
Tags: FDA, Teva Pharmaceutical Industries, ANDA, Adderall XR capsules
The US Patent and Trademark Office (USPTO) has granted notice of allowance (NOA) to Collegium Pharmaceutical's patent application NO.12/823,628 covering a tamper-resistant, extended-release opioid product. The patent entitled, ...
Tags: USPTO, NOA, Collegium Opioid Product
The US Food and Drug Administration (FDA) has granted approval to Medtronic's AIRvance Bone Screw System. The approval allows surgeons to perform a hyoid suspension procedure independently or in combination with other procedures including ...
Blue Belt Technologies has treated the first three US patients for unicondylar knee replacement (UKR), using its NavioPFS orthopedic surgical system. The UKR procedures, performed at the US-based Community Regional Medical Center, ...
Tags: Blue Belt Technologies, UKR, NavioPFS orthopedic surgical system
Medtronic has launched new MR-Conditional pacing system for use with MRI scanners in the US, following the approval from the US Food and Drug Administration (FDA). The Advisa DR MRI SureScan pacing system, which includes an Advisa MRI ...
The US Food and Drug Administration (FDA) has cleared a 510(k) pre-marketing notification (PMA) application of Paragonix Technologies' single-use organ preservation device Paragonix Sherpa Pak Cardiac Transport System (CTS). The CTS helps ...
Tags: FDA, PMA, Paragonix Technologies, CTS