BD (NYSE:BDX) announced today that it received FDA approval for its Onclarity HPV assay for use with the ThinPrep Pap test. The ThinPrep Pap test, developed by Hologic (Nasaq:HOLX), offers Pap and HPV testing from one vial. It accompanies the BD SurePath liquid-based Pap test vial as the most commonly used vials by labs in […]
FDA clears cranial procedure guidance system from Stryker
Stryker (NYSE:SYK) announced today that it received FDA 510(k) clearance for its Q Guidance System with cranial guidance software. Kalamazoo, Michigan-based Stryker designed the Q Guidance System as an image-based planning and intraoperative platform. The company launched the system for spinal applications in September 2022. This latest iteration offers support for cranial surgeries. Q Guidance […]
Dentsply Sirona to lay off up to 10% of workforce in restructuring effort
Dentsply Sirona (Nasdaq:XRAY) announced a cost-saving restructuring plan that includes layoffs of up to 10% of its employees. Charlotte, North Carolina-based Dentsply plans to reduce its global workforce by 8% to 10% as part of its plan. The dental equipment maker’s most recent headcount had 15,000 employees, meaning the cuts could affect as many as […]
Philips recalls certain reworked Trilogy, Garbin ventilators
The FDA issued a notice labeling the recall of certain Philips (NYSE:PHG) Respironics Trilogy and Garbin ventilators as Class I, the most serious kind This recall relates to Philips Respironics Trilogy 100, Trilogy 200 and Garbin Plus ventilators. Philips had reworked the ventilators as it responded to its massive ongoing CPAP and BiPAP recall. Here’s […]
Medtronic wins CE mark for extravascular defibrillator system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Aurora EV-ICD and Epsila EV MRI SureScan system. The Aurora EV-ICD and Epsila EV defibrillation lead treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. The EV-ICD (extravascular implantable cardioverter-defibrillator) system offers the live-saving benefits of traditional ICDs. However, it […]
Shockwave Medical stock ticks up on massive Q4 earnings beat
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 […]