Align Technology (Nasdaq:ALGN) announced today that it entered into a new accelerated stock repurchase agreement with Citibank. Tempe, Arizona-based Align agreed to repurchase $250 million of its common stock. It falls under its $1 billion stock repurchase agreement announced in May 2021. The company’s most recent buyback took place in October 2022 through a $200 […]
Tidepool Loop automated insulin delivery system wins FDA clearance
Tidepool announced recently that the FDA cleared its Tidepool Loop, a “do-it-yourself,” (DIY) automated insulin delivery (AID) system. Palo Alto, California-based Tidepool is a non-profit diabetes data management group. It created the hybrid, closed-loop AID app for compatibility with multiple insulin pumps and continuous glucose monitors. The company announced collaborations in the past that include […]
Know Labs inks partnerships to accelerate progress toward FDA clearance for glucose monitor
Know Labs (NYSE:KNW) announced that it entered into a series of strategic partnerships as it looks to move toward a major regulatory nod. Seattle-based Know Labs develops the Bio-RFID technology. It uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. This technology integrates into wearable, mobile or bench-top […]
Vero Biotech wins FDA approval for inhaled nitric oxide delivery with anesthesia in the OR
Vero Biotech announced that the FDA approved its second-generation Genosyl system for use with rebreathing anesthesia in the operating room setting. Atlanta-based Vero Biotech designed Genosyl for inhaled nitric oxide (iNO) delivery. This approval covers the second-generation Genosyl device. The third-generation device — which recently received FDA approval — has not yet been tested with […]
FDA clears single-use ureteroscope system from Boston Scientific
Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its LithoVue Elite single-use ureteroscope system. Marlborough, Massachusetts-based Boston Scientific plans a limited U.S. launch for the digital, flexible ureteroscope system in the coming weeks. The company said in a news release that it’s the first ureteroscope system that can monitor intrarenal pressure […]
Zimmer Biomet beats The Street in Q4, expects continued ‘macro pressures’
Zimmer Biomet (NYSE:ZBH) stock is up today on fourth-quarter results that beat the consensus forecast. Shares of ZBH rose more than 1% at $129.75 apiece by afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up more than 14%. The Warsaw, Indiana–based orthopedic device […]
Drop in COVID-19 diagnostic sales hampers Siemens Healthineers in Q1
Siemens Healthineers today announced first-quarter financial results that include a projection of single-digit growth in 2023. Despite growth ahead, Siemens Healthineers reported adjusted earnings per share at €0.47 (51¢) for the three months ended Dec. 31, 2022. It reported revenues of nearly €5.1 billion ($5.6 billion) and profits totaling €426 million ($464.9 million). The company […]
Varian wins U.S., European clearance for radiotherapy systems
Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance and CE mark for its Halcyon and Ethos systems. Both radiotherapy systems feature Varian’s HyperSight imaging solution. HyperSight enables clinicians to capture high-quality images of patients during their daily radiation treatments. The images help in the daily localization of patient tumors and their uses […]
FDA clears biology-guided radiotherapy from RefleXion
RefleXion Medical announced today that the FDA cleared its Scintix biology-guided radiotherapy treatment for cancer. Hayward, California-based RefleXion designed the Scintix platform for use in treating both early- and late-stage cancers. The company said Scintix is the first and only radiotherapy that allows each cancer’s unique biology to autonomously determine how much radiation to deliver. […]
LivaNova launches implantable pulse generator for treating epilepsy
LivaNova (Nasdaq:LIVN) announced today that it launched its SenTiva Duo implantable pulse generator (IPG) for providing VNS Therapy. SenTiva Duo received FDA 510(k) clearance. LivaNova has made it available in the U.S. The London-based company designed its VNS Therapy as a unique approach for treating drug-resistant epilepsy. Vagus nerve stimulation (VNS) can prevent seizures before […]
Accuray stock rises on Street-beating Q2
Accuray (Nasdaq:ARAY) shares rose this morning on second-quarter results that topped the consensus forecast. ARAY shares ticked up 12.1% at $2.75 apiece. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 14.4%. The Sunnyvale, California–based radiation oncology company posted losses of $1.9 million. That amounts to losses […]