Search Results for “medical devices” – Page 49 – media

Henry Schein reports more disruption as cyberattackers take credit

BY JIM HAMMERAND Henry Schein (Nasdaq: HSIC)+ said today that it is working to bring its ecommerce platform back up after more problems related to its cyberattack. The medical device manufacturer and distributor said last week that its ecommerce platform and other applications were unavailable and that “the threat actor from the previously disclosed cyber incident has claimed responsibility.” Today, the company said its ecommerce platform is back online in the U.S. and was expected to be restored in Canada and Europe “shortly.” Henry Schein said it continued to take orders via alternate methods previously communicated to customers, and continued shipping products. Earlier this month, the company warned customers and suppliers that their sensitive information may have been exposed in the cyberattack. Henry Schein first disclosed the cyber security incident in October. A ransomware gang known as BlackCat/ALPHV later said they encrypted the company’s systems and stole 35 TB of ...
- Source: drugdu
- 206
- November 29, 2023
Another medtech reports a cybersecurity incident

BY JIM HAMMERAND The London-based device developer disclosed the cybersecurity incident in a Securities and Exchange Commission filing this week, saying the incident disrupted portions of its information technology systems and business operations. “Promptly after detecting the issue, the company began an investigation with assistance from external cybersecurity experts and is coordinating with law enforcement,” LivaNova said in the filing. “The company continues to assess what information and systems were impacted and is executing its incident response plan, including implementing remediation measures to mitigate the impact of the incident.” “The company has and will continue to take actions to remediate the issue, such as taking certain systems offline,” the company continued. LivaNova said it expects continued disruption of its operations, and can’t yet determine “the extent of the impact from such event on its business, results of operations, cash flows or financial condition.” Earlier this year, the SEC launched new ...
- Source: drugdu
- 99
- November 24, 2023
Olympus receives Class I recall label for another bronchoscope safety issue

Dive Brief Olympus Corporation has issued another corrective action for numerous models of bronchoscopes after reports of injuries where patients may have suffered burns to their airways or lungs. The corrective action came after four adverse event reports of “endobronchial combustion during therapeutic procedures with Olympus bronchoscopes,” an Olympus spokesperson said in an emailed statement. The Food and Drug Administration labeled the corrective action as a Class I recall, though Olympus said in a Nov. 9 press release that no devices need to be removed. The recall affects nearly 68,000 devices according to an FDA report entry. Dive Insight Bronchoscopes are used for endoscopic diagnosis and treatment in the airways to the lungs. In an Oct. 12 letter to customers, Olympus warned healthcare personnel about the risks of conducting high-frequency cauterization with Olympus bronchoscopes in an oxygenated environment, which may result in combustion during cauterization. The company said in a ...
- Source: drugdu
- 147
- November 16, 2023
Major trial finds apixaban reduces stroke risk in patients with device-detected atrial fibrillation

The widely available blood thinner apixaban substantially reduced stroke in at-risk patients with a type of atrial fibrillation only detectable by a pacemaker or other implanted cardiac electronic device, a global study has found. The oral anticoagulant medication, which helps to prevent dangerous blood clots by thinning the blood, reduced the risk of stroke and blood clotting by 37% and reduced fatal or disabling stroke by 49% in individuals with device-detected atrial fibrillation, also known as sub-clinical atrial fibrillation (SCAF). This condition is not easily detectable through standard tests like electrocardiograms, unlike clinical atrial fibrillation. The study was published on Nov. 12 in the New England Journal of Medicine (NEJM) and simultaneously presented at the American Heart Association Scientific Sessions by lead researcher Jeff Healey, a senior scientist at the Population Health Research Institute (PHRI), a joint research institute of McMaster University and Hamilton Health Sciences. Healey and a global ...
- Source: drugdu
- 107
- November 15, 2023
J&J links radiofrequency catheter to improved quality of life in atrial fibrillation study

Dive Brief Johnson & Johnson has linked its Qdot Micro radiofrequency (RF) catheter to improved quality of life in patients with paroxysmal atrial fibrillation (AFib). The single-arm study found that, compared to baseline, scores on an AFib quality-of-life scale improved and use of antiarrhythmic drugs fell after people underwent treatment with the device. Qdot Micro, which received approval in the U.S. in 2022, is set to face competition from pulsed field ablation (PFA) devices. A Boston Scientific study suggests PFA and thermal ablation result in similar levels of improvement in quality of life. Dive Insight Qdot Micro is temperature-controlled, contact force-sensing, RF catheter. The temperature control feature supports the use of higher radiofrequency power in short bursts, an approach that J&J sees as a way to improve efficacy without compromising safety. J&J published 12-month data on the effectiveness of the device in its Q-FFICIENCY study earlier this year. The latest ...
- Source: drugdu
- 96
- November 9, 2023
FDA warning letter accuses Wavi of selling unapproved neurological device

Dive Brief The Food and Drug Administration has sent a warning letter to Wavi, accusing the company of selling an unauthorized device to help diagnose patients with potential neurological conditions. Wavi markets its headset, plus associated devices and software, as providing a baseline scan for patients who have a traumatic event, an injury or are worried about their brain as they age. The FDA, which sent inspectors to Wavi’s facility in Denver in March, views the technology as a medical device and sent a warning letter because the product lacks premarket approval. Dive Insight In the letter, the FDA states that Wavi promotes and distributes Wavi Desktop, a product that collects, analyzes and interprets electroencephalograph data, event-related potentials and heart rate variability data. The instruction manual “contains evidence that the device is intended to aid in the evaluation of autonomic nervous system function, head injury, depression, attention-deficit/hyperactivity disorder, anxiety, and ...
- Source: drugdu
- 218
- November 3, 2023
Judge grants preliminary approval to Philips class action settlement

BY CHRIS NEWMARKER A federal judge in Pennsylvania has granted preliminary approval to an economic loss settlement involving lawsuits filed against Philips over its massive recall of CPAPs and other respiratory devices. U.S. District Court Judge Joy Flowers Conti’s order, filed yesterday, could just be the beginning of settling what has arguably been one of the medical device industry’s most serious recalls in recent decades. (Here is a full timeline of the Philips recall.) According to plaintiffs’ co-lead counsel, Philips has agreed to provide at least $479 million in compensation to device users who paid out of pocket to buy or rent the recalled devices, as well as payers who reimbursed users for the devices. Awards could range between $55.63 and $1,552.25 for each recalled device, plus a $100 award apiece for those who returned devices. “We are pleased that Judge Conti granted preliminary approval of the Philips economic loss ...
- Source: drugdu
- 161
- October 14, 2023
Haemonetics inks $253M OpSens buyout, adding cardiology guidewires to portfolio

Dive Brief Haemonetics has struck a deal to buy the interventional cardiology company OpSens for around $253 million. OpSens sells two pressure-sensing guidewires for use in percutaneous coronary intervention (PCI) and transcatheter aortic valve replacement (TAVR) procedures. The devices helped OpSens generate sales of C$34.2 million ($25.2 million) over the first nine months of its current fiscal year. Analysts at Needham told investors the takeover is consistent with the M&A strategy outlined by management and will give Haemonetics devices that complement its vascular closure products. Dive Insight Haemonetics created its vascular closure business early in 2021 by acquiring Cardiva Medical for $510 million. On a quarterly results conference call in May, an analyst said the subsequent growth has been “phenomenal.” Haemonetics voiced an appetite for more deals on its next quarterly call, when CFO James D’Arecca set out plans to accelerate growth through M&A. D’Arecca and the rest of the ...
- Source: drugdu
- 110
- October 13, 2023
Lumicell co-founder wins Nobel Prize in Chemistry

The co-founder of a fluorescence-guided imaging technology firm has been awarded part of the Nobel Prize in Chemistry in acknowledgement of his research into quantum dots. The Nobel Prize Committee said that Moungi Bawendi revolutionised the chemical production of quantum dots, resulting in almost perfect particles. Quantum dots are nanoparticles so tiny that their size determines their properties. They have frequently been employed in the use of medical imaging devices such as those provided by the company Bawendi co-founded, Lumicell. The Nobel Prize Committee said: “Quantum dots now illuminate computer monitors and television screens based on QLED technology. They also add nuance to the light of some LED lamps, and biochemists and doctors use them to map biological tissue.” The Royal Swedish Academy of Sciences additionally awarded the prize to two other researchers, Louis E. Brus and Alexei I. Ekimov. Both of whom were pivotal in the development of quantum ...
- Source: drugdu
- 134
- October 7, 2023
Study finds mixed results for mobile health app in cardiac rehabilitation

Nearly one in three Americans wear a wearable device, like a smartwatch, to track their health and fitness. Studies have shown positive effects of increasing movement in ways that can be measured by these devices, especially for people who recently had a heart attack or other cardiovascular event. But a Michigan Medicine-led report shows that adding a mobile health application to such devices yields mixed results. Tailored text messages to encourage high-risk people to move more may improve some short-term outcomes but doesn’t always improve physical activity levels for everyone. The randomized clinical trial, called the Virtual AppLication-supported Environment To Increase Exercise Study, or VALENTINE, compared the physical activity levels of patients enrolled in cardiac rehabilitation who received the mobile health intervention to those who did not. Cardiac rehabilitation is a medically supervised program is recommended after cardiovascular events, such as heart attack or surgery. Of the more than 200 ...
- Source: drugdu
- 105
- September 28, 2023

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