Shockwave Medical (Nasdaq:SWAV) shares rose this morning on fourth-quarter results that came in ahead of the consensus forecast. Shares of SWAV ticked up 5.3% at $201.35 apeice after the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 10.6%. The Santa Clara, California-based cardiovascular […]
Asensus, Karl Storz partner on surgical robot marketing, development
Asensus Surgical (NYSE:ASXC) announced today that it entered into a memorandum of understanding with Karl Storz VentureONE. Karl Storz VentureOne is a wholly-owned subsidiary of Karl Storz SE, a maker of endoscopes and other medical instruments and devices. The family-owned company closely collaborates with surgeons and healthcare partners around the globe on technologies for minimally invasive […]
BD issues vulnerability warning for Alaris infusion monitoring software
BD (NYSE:BDX) today issued a voluntary notification regarding cybersecurity vulnerabilities with its Alaris Infusion Central software. Alaris Infusion Central, a standalone software — separate from pumps — provides data from the Alaris pumps. It allows healthcare providers to monitor infusion data sent from Alaris Plus and Alaris neXus pumps on a computer. Alaris Infusion Central […]
GE HealthCare recalls scanner for patient crushing risk
The FDA labeled the recall of the GE HealthCare (Nasdaq:GEHC) Nuclear Medicine 600/800 Series systems as Class I, the most serious kind. GE HealthCare recalled the imaging platforms after identifying an issue with two mechanisms. These mechanisms prevent uncontrolled detector movement. The issues could result in the suspended mass of the detector potentially falling. A […]
Henry Schein stock dips despite Street-beating Q4 revenues
Henry Schein (Nasdaq:HSIC) shares took a hit today despite fourth-quarter revenues that topped the consensus forecast. Shares of HSIC dipped 5.8% to $83.51 apiece in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 11.1%. The Melville, New York-based dental device maker posted profits […]
Delcath Systems appoints new board chair
Delcath Systems (Nasdaq:DCTH) announced today that its board of directors voted to appoint John R. Sylvester as its new chair. Sylvester joined Delcath as a director in July 2019. He currently serves as CEO of Curium Pharma’s SPECT and international businesses. Previously, Sylvester served as BTG’s chief commercial officer, leading the company’s interventional oncology and […]
EOFlow invests $7.7B in Pharmeo subsidiary for non-insulin drug delivery development
EOFlow announced today that it plans to invest $7.7 billion (9.9 billion Korean Won) in its wholly-owned Pharmeo subsidiary. The investment aims to advance R&D and commercialization of non-insulin drugs with EOFlow’s wearable drug delivery system. Get the full story at our sister site, Drug Delivery Business News.
FDA committee unanimously votes in favor of over-the-counter Narcan from Emergent BioSolutions
Emergent BioSolutions (NYSE:EBS) announced today that its over-the-counter Narcan (naloxone HCl) nasal spray received unanimous approval from governing bodies. The vote came from the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. A total of 19 voters decided in favor of the benefit-risk profile for Narcan. The voters support […]
RightEye receives FDA warning that its product is a medical device
An FDA inspection claims that eye-tracking biomarker developer RightEye misbranded and adulterated its medical device. The agency wrote in a letter, dated Dec. 20, 2022, that it inspected RightEye’s Bethesda, Maryland facility over 10 days in June and July 2022. In this inspection, it declared the RightEye Vision System a Class II Nystagmograph medical device. […]
Bausch + Lomb names Brent Saunders as new CEO
Bausch + Lomb (NYSE:BLCO) announced today that it appointed Brent Saunders as CEO and chair of its board of directors. Saunders succeeds Joseph C. Papa in the role, effective March 6, 2023. Papa announced his intention to step down in July 2022. When Papa announced his plans to depart, the optical and ophthalmic device maker […]
Hologic NovaSure V5 endometrial ablation device wins European, Canadian approval
Hologic (Nasdaq:HOLX) announced today that Canadian and European officials approved its NovaSure V5 global endometrial ablation (GEA) device. Marlborough, Massachusetts-based Hologic designed the device to treat a wide range of cervical and uterine anatomies. It offers treatment for abnormal uterine bleeding. In a news release, Hologic cites 97% patient satisfaction with NovaSure. The device also […]