Europe Healthcare Market

CE label expansion was granted to the Ventana PD-L1 (SP263) assay for use as a companion diagnostic to identify patients with non–small cell lung cancer (NSCLC) who are eligible for treatment with adjuvant atezolizumab (Tecentriq). 1 “With early detection of lung cancer, it is possible to give patients more treatment options and potentially improve a patient's outcome,” Jill German, head of Pathology Lab at Roche Diagnostics, said in a press release. “We are proud to offer a PD-L1 test that may qualify lung cancer patients for [atezolizumab] therapy. With this latest expansion, clinicians can consider multiple targeted immunotherapy options with one test to quickly determine the right treatment for each patient.” On June 14, 2022, the  European Commission approved atezolizumab  for use as adjuvant therapy following complete resection and platinum-based chemotherapy in adult patients with NSCLC at high risk of recurrence whose tumors do not have  EGFR  mutations or...

  curasan AG (Frankfurt, Germany), a pioneer and leading global provider of biomaterials for bone and tissue regeneration in dental and orthobiologic indications, broadens its product portfolio with  CERASORB ®  CPC  (Calcium Phosphate Cement) Bone Void Fillers for maxillofacial, orthopedic and trauma surgery. Bone augmentation and regeneration in maxillofacial, orthopedic and trauma surgery for surgical reconstructions remains a challenge. Where natural healing processes are insufficient, enhanced bone augmentation by means of biomimetic scaffolds is needed. Existing concepts for structural and functional repair of lost bone, e. g. after trauma, infections, tumor resections, or due to skeletal abnormalities are widespread, but have limitations and often result in additional bottlenecks for patients, surgeons and the healthcare systems alike. “By adding the ready-to-use, sterile packed, self-setting bone void filler  CERASORB ®  CPC  to curasan’s ortho...

The nation’s top health officials believed they had finally hit upon a solution to quell weeks of public criticism about the straggling government response  to the  monkeypox outbreak  spreading across the country this summer. They would stretch the nation’s  limited supply  of the only  FDA-approved vaccine  for monkeypox by  splitting doses  to cover five times as many people — an admission, after repeated reassurances by top government officials, that the United States did not have enough shots for every at-risk American, after all. But after Health and Human Services officials announced their proposal on Aug. 4, Paul Chaplin, chief executive of Bavarian Nordic, the vaccine’s manufacturer, called a senior U.S. health official and accused the Biden administration of breaching its contracts with his company by planning to use the doses in an unapproved manner. Even worse, said two people with knowledge of the episode, Chaplin threatened to c...

Robotic prostatectomy performed by Doctor Alexandre Mottrie at Onze-Lieve-Vrouw Ziekenhuis (OLV) in Aalst, Belgium DUBLIN and AALST, Belgium, Feb. 2, 2022 /PRNewswire(opens new window)/ --Medtronic plc (NYSE:MDT), a global leader in healthcare technology, and OLV Hospital Aalst today announced that the first clinical procedure in Europe was performed with the Hugo™ robotic-assisted surgery (RAS) system. The robotic prostatectomy was performed by Prof. Alexandre Mottrie, M.D., head of urology at OLV Hospital in Aalst, Belgium, and chief executive officer and founder of the Belgium-based ORSI Academy, a multidisciplinary center for training, research and development, and data analysis to improve minimally invasive surgery best practices. "Performing Europe's very first procedure with the Hugo RAS system is a career highlight for me," said Dr. Mottrie. "With more than two decades and 4,000 robotic-assisted surgery proced...

Launching for the first time in London, UK on 14 and 15 November will be the Medical Devices & IVD Conference. The conference will consider the evolving regulatory landscape for digital health software. Industry professionals will address post-market surveillance and vigilance, clinical evaluations and investigations, medical device regulatory affairs in global markets and much more. Interested parties can register at  http://www.medicaldevices-ivd.com/PR2PP  – register by 30 September to save £100. Delegates will gain the chance to: •Engage with notified body and competent authority representatives addressing key MDR and IVDR requirements •Gain insights from pharma regulatory experts in compliance and companion diagnostics •Understand the latest guidance on IVD Regulations to overcome common challenges, in addition to considering evolving global regulations •Examine post-market expectations for surveillance and vigilance of your medical devices •Delve into advancements in...

  An experimental gene therapy for hemophilia B boosted blood clotting protein levels in a small group of patients with a severe form of the rare bleeding condition, allowing all but one to discontinue regular preventive treatment,  study results published Thursday  in The New England Journal of Medicine show.  After a median follow-up of more than two years, nine of the ten men who were treated in the clinical trial had sustained clotting protein activity, including five whose levels were within what’s considered a normal range. One participant initially saw his levels rise, but had to resume receiving other treatment a year later because the gene therapy’s effects waned.  Eight participants experienced fewer bleeding episodes following treatment than before, according to the results. Bleeding episodes, even minor ones, can be dangerous in people with hemophilia B who lack or have low levels of the protein, called factor IX, that helps clot blood....