Hologic is set to acquire breast surgical guidance company Endomagnetics for $310 million. Endomag develops and sells breast surgery localization and lymphatic tracing technology. It makes products like the Magseed marker for magnetic tissue localization before surgery. It also develops the Magtrace lymphatic tracing injectable for breast cancer staging and the Sentimag platform that supports […]
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Artivion has positive heart valve data
Artivion (NYSE:AORT) today announced positive outcomes from a post-market study of its On-X aortic heart valve. The company shared five-year real-world safety and efficacy data demonstrating even better outcomes than predicted by a previous study. Other data highlighted positive aortic remodeling outcomes as well and zero distal anastomotic new entry (DANE) tears. Artivion’s five-year study […]
ClearPoint Neuro wins FDA clearance for neuro laser therapy accessory
ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory. It marks the second new product introduction in 2024 for the company, with its stereotactic guidance system garnering clearance in January. The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator […]
Sight Sciences to earn $34M from Alcon patent infringement suit
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 […]
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 […]