Sight Sciences (Nasdaq:SGHT) announced today that it received a jury trial verdict awarding it $34 million from a patent infringement case against Alcon. The company filed the case on Sept. 16, 2021, against Alcon, Alcon Vision, Alcon Research and Ivantis (collectively Alcon) in the U.S. Menlo Park, California-based Sight Sciences asserted that Alcon’s sale of […]
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FDA issues warning letter to Cardinal Health for adulterated and misbranded medical devices
The FDA recently issued a warning letter to Cardinal Health following an inspection at one of its facilities. The inspection revealed unapproved device violations pertaining to the Monoject Leur-lock tip syringes and the Monoject Enteral Feeding Syringes, as well as quality system regulation violations. Dublin, Ohio-based Cardinal Health was found to be marketing convenience kits […]
BCI maker Blackrock Neurotech picks up $200M investment from cryptocurrency company
Tether, a digital asset industry leader, announced today that it made a $200 million strategic investment in Blackrock Neurotech. With the investment — made through a newly formed venture division called Tether Evo — Tether is now the majority stakeholder in Blackrock Neurotech, a maker of neurotechnology such as brain-computer interfaces (BCIs). Blackrock Neurotech develops […]
FDA clears new patient monitor from GE HealthCare
GE HealthCare announced today that it received FDA 510(k) clearance for its Portrait VSM vital signs monitor. Portrait VSM provides clinicians with an accurate view of patient vital signs to support timely clinical decisions. It utilizes the SuperSTAT non-invasive blood pressure algorithm to provide precise and accurate measurement readings. Through wireless connectivity and seamless EMR […]
Philips stock skyrockets on positive outlook, $1.1B Respironics settlement in spite of Q1 misses
Philips shares got a huge boost today despite first-quarter results that fell shy of the consensus forecast on Wall Street. Investors appeared to react positively to recent updates on the company’s long-running Respironics recall. Shares of PHG rose more than 35% to $28.50 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes […]
How Philips’ significant respiratory devices recall unfolded
There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline. Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could […]
Abbott wins FDA approval for dissolving drug-eluting scaffold
Abbott announced today that the FDA approved its Esprit everolimus-eluting resorbable scaffold system. The Esprit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. Abbott says that before this approval, there were no stents or drug-coated […]
Philips gets judge’s OK to settle Respironics recall economic losses
Philips will pay at least $613 million to settle economic lawsuits related to its recall of millions of CPAPs and other respiratory devices. U.S. District Court Judge Joy Flowers Conti, who has been overseeing the multidistrict litigation out of her court in Western Pennsylvania, approved the final settlement yesterday. “The amount of value created and […]
Roivios wins FDA breakthrough nod for renal assist device
Roivios announced today that it received FDA breakthrough device designation for its JuxtaFlow renal assist device (RAD). The Bahamas-based medical device company designed JuxtaFlow to improve treatments for patients facing kidney disease during cardiac surgery. JuxtaFlow uses a unique, gentle negative pressure technique on the kidneys’ urine-collecting system. It enhances function and shield against hypoxia-induced […]
Align Technology announces $150M repurchase program
Align Technology (Nasdaq:ALGN) announced today that it plans to repurchase $150 million of its own common stock. The open-market repurchase falls under the company’s $1 billion stock repurchase program approved in January 2023. Align Technology executed a $250 million repurchase in February 2023 with Citibank. In October, the company triggered another $250 million repurchase in an […]
4WEB Medical wins regulatory clearance for Anterior Spine Truss System
4WEB Medical this week announced it received regulatory clearance for its Anterior Spine Truss System with Anchor Fixation (ASTS-AF). The Dallas-based orthopedic implant company’s current anterior lumbar implant offering includes a traditional interbody with the option of an integrated plate and a standalone interbody with screw fixation. The regulatory clearance expands the company’s portfolio to […]