Strata Skin Sciences (NSDQ:SSKN) announced that it won FDA 510(k) clearance for its Xtrac Momentum excimer laser system for treating a number of skin diseases. The Xtrac laser is designed to deliver a highly targeted therapeutic beam of UVB light in the treatment of psoriasis, vitiligo, eczema, atopic dermatitis and leukoderma. It is made in three […]
Hillrom shares slide despite topping Street forecast
Hillrom (NYSE:HRC) shares dipped today on first-quarter results that fell short of last year’s numbers but still topped the consensus forecast. The Chicago-based company posted profits of $39.8 million, or 59¢ per share, on sales of $685 million for the three months ended Dec. 31, 2019, for a 5.7% bottom-line slide on sales growth of 0.15%. […]
Brainlab acquires VisionTree Software
Brainlab announced that it completed the acquisition of patient-centric data collection and health management company VisionTree Software. Munich, Germany–based Brainlab said the acquisition highlights the company’s commitment to taking a closer look at patient quality of life and condition post-treatment. San Diego–based VisionTree Software develops cloud-based data collection and health management solutions that Brainlab plans […]
FDA grants Medtronic an IDE to study new tech for ablating heart tissue
Medtronic (NYSE:MDT) announced today that it won FDA approval to move forward with an investigational device exemption trial to evaluate the safety and effectiveness of its PulseSelect pulsed-field ablation (PFA) system. The PulseSelect system is designed to use the pulsed electric fields to treat atrial fibrillation (Afib). It uses the fields to ablate or create lesions […]
BioVentrix granted CE Mark extension for Revivent TC system
BioVentrix announced today that it received an extension of its CE Mark for the Revivent TC transcatheter ventricular enhancement system for heart failure. The extension of the initial CE Mark approval BioVentrix won in 2016 allows the device to be marketed throughout European Union member nations until May 2024, according to a news release. BioVentrix’s […]
Cardinal Health recalls 9 million surgical gowns, sends hospitals scrambling
Cardinal Health (NYSE:CAH) announced that it is voluntarily recalling 9.1 million surgical gowns produced by an unnamed contract manufacturer after discovering quality issues with the product. The Dublin, Ohio-based company said that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law. Some of the gowns were also […]
Owens & Minor’s ArcRoyal warns of excess ethylene oxide in tubing sets
Owens & Minor (NYSE:OMI) company ArcRoyal issued an urgent field safety notice in Europe to warn of an issue with ethylene oxide (EtO) residue in custom procedure trays that contain an insufflation tubing set with gas from Karl Storz. Karl Storz initiated the recall, noting that the affected products contained increased residues of the carcinogenic sterilant […]
Mindray issues urgent field safety notice for Genius 2 tympanic thermometers
Mindray Medical issued an urgent field safety notice in Europe to warn of a calibration-related accuracy issue with Cardinal Health’s (NYSE:CAH) Genius 2 tympanic thermometers that are integrated into four versions of the Mindray VS-900 patient monitors. The affected Genius 2 thermometers were manufactured after Oct. 1, 2016, and may have been distributed with the Mindray […]
Aethlon Medical completes $3.8m offering
Aethlon Medical (NSDQ:AEMD) announced that it completed its previously announced registered direct offering of nearly 1.9 million shares of its common stock for nearly $3.8 million in proceeds. The shares, offered at a purchase price of $2 per share, totaled approximately $3.77 million in gross proceeds. Aethlon additionally issued unregistered warrants to purchase up to 942,689 […]
Major Texas health system will use CHF Solutions’ Aquadex FlexFlow system
CHF Solutions (NSDQ:CHFS) announced today that Texas-based Baylor Scott & White Health began offering aquapheresis therapy using its Aquadex FlexFlow system. Temple, Texas-based Baylor Scott & White Health is a major not-for-profit healthcare system in the state and among the largest in the U.S. The health system is now set to offer the Aquadex Flexflow at […]
Bayer and Exscientia partner to bring AI to drug discovery
Bayer (ETR:BAYN) announced that it is entering into a collaboration agreement with artificial intelligence drug discovery company Exscientia to identify and optimize novel lead structures for potential drug candidates in treating cardiovascular and oncological diseases. The agreement, announced earlier this month, is slated to see the companies work together on early research projects combining Exscientia’s proprietary […]
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