Biofrontera (ETR:B8F) shares are up today after the said it won pre-market approval from the FDA for its drug-device combination treatment for a type of sun-induced skin cancer. Leverkusen, Germany-based Biofrontera said the approval covers its Ameluz drug and BF-RhodoLED medical device for what it calls “photodynamic therapy” to treat mild to moderate actinic keratosis of the face […]
Food & Drug Administration (FDA)
Health advocates pan research funding bills that would streamline FDA approvals
Measures in the U.S. Congress that would link research funding to moves designed to simplify the approval process for medical devices and drugs is reportedly drawing flak from public health advocates, including a former FDA commissioner. Last July, the U.S. House of Representatives passed the 21st Century Cures Act, a sweeping bill to speed new […]
Lungpacer Medical hits the FDA fast track with phrenic nerve pacer
Lungpacer Medical said it won an expedited access pathway designation from the FDA for the diaphragm pacing system it’s developing to treat patients who can’t be weaned from mechanical ventilation. The Lungpacer DPS device is a neurostimulation system designed to exercise and strengthen the diaphragm via the temporary, transcatheter stimulation of the phrenic nerve. The FDA’s […]
TransEnterix shelves SurgiBot after FDA denial, turns to ALF-X
TransEnterix (NYSE:TRXC) is shelving its SurgiBot robot-assisted surgery platform and focusing on the ALF-X platform it acquired last year. Stock prices for the Research Triangle Park, N.C.-based plunged last month when TransEnterix revealed that the FDA denied its submission for 510(k) clearance for the SurgiBot, which it claims as the 1st patient-side robotically enhanced laparoscopy platform designed […]
NinePoint Medical wins FDA nod for real-time targeting on NvisionVLE device
NinePoint Medical said today that it won 510(k) clearance from the FDA for a real-time targeting feature on its flagship NvisionVLE gastrointestinal imaging device. NvisionVLE uses optical coherence tomography to perform what it calls volumetric laser endomicroscopy to produce real-time, high-resolution cross-sectional images of the GI tract. The new targeting feature, enabling doctors to locate and mark areas […]
FDA releases April 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD April 2016 TOTAL 510(k)s THIS PERIOD 239 TOTAL WITH SUMMARIES 224 TOTAL WITH STATEMENTS 15 DEVICE: Applanation Tonometer SHANGHAI MEDIWORKS PRECISION INSTR510(k) NO: K142263(Traditional) ATTN: Weida Zhan PHONE NO : 8621 542 60421 Zone A, 2nd Floor, No. 69, Lane 19SE DECISION MADE: […]
Intarcia raises another $75m, touts top-line safety data in pivotal trial
Intarcia Therapeutics said today that it raised another $75 million in a debt financing round and touted the top-line cardiovascular safety data from the final phase in its clinical program for its ITCA 650 implantable drug pump for Type II diabetics. Boston-based Intarcia said it plans to begin filing for U.S. approval from the FDA during the 3rd […]
FDA: B. Braun Dialog+ hemodialysis recall is Class I
B. Braun Medical is recalling its Dialog+ Hemodialysis systems due to an issue with defective conductivity sensors. The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences […]
Boston Scientific wins FDA nod for Rhythmia cardiac mapping and ablation catheters
Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for a pair of ablation catheters that use the 3D cardiac mapping technology it bought from Rhythmia Medical back in 2012. Marlborough, Mass.-based Boston Scientific said the federal safety watchdog gave the green light to its IntellaNav XP and IntellaNav MiFi XP mapping and ablation […]
Biotronik wins FDA nod for Iperia ProMRI HF-T defibrillator
Biotronik said today it won FDA premarket approval for its Iperia ProMRI HF-T cardiac resynchronization defibrillator, which is designed to be compatible with diagnostic magnetic resonance imaging scans. The Iperia line of devices also features remote monitoring with daily automatic transmission and closed loop stimulation designed to adapt heart rate in response to physiological demands, […]
Another FDA win for Synaptive Medical with its ImageDrive Pro
Synaptive Medical said it won FDA 510(k) clearance for its ImageDrive Pro informatics system designed to integrate its existing BrightMatter technology into multiple platforms. The company said the new platform will allow for interoperability across all of BrightMatter’s solutions, including imaging, surgical planning, navigation and automated positioning of high definition optics. BrightMatter gives 3D visuals […]