Dive Brief: Abbott on Monday said FDA approved a less invasive surgical technique for its HeartMate 3 heart pump that will spare more patients from open heart surgery to have the device implanted. Called lateral thoracotomy, the alternative procedure enables…
Partnership aims to improve regulatory compliance management in life sciences
Natural Language Generation (NLG) company and document drafting technology supplier Litera have announced a partnership with Yseop to provide life science companies with more efficient and effective management of regulatory compliance processes. Bringing a new drug to market takes between 10…
PharmaLex merges with CompliMed
PharmaLex Group has completed its merger with CompliMed in the United Kingdom. CompliMed is the UK’s leading Healthcare Compliance Consultancy specialising in the ABPI Code of Practice. Their services include training, e-learning, outsourcing, audits, SOPs, medical review and final signatory…
New FDA cleared wearables for nausea on display at CES 2020
Wearables player Reliefband Technologies, has announced the unveiling of its new travel and sport therapeutic devices. The company specialises in technology that aims to prevent and treat nausea and vomiting symptoms, and has received have received U.S. Food and Drug…
Dural sealant patch receives CE mark
The device will be launched with immediate effect. Approval of the CE mark is based on data from Polyganics’ Encase I clinical trial, evaluating the safety and performance of Liqoseal in reducing cerebrospinal fluid (CSF) leakage after elective cranial surgery. Three-month…
Transgene starts trials of ‘digital’ cancer vaccine with NEC
Undeterred by two clinical failures for its cancer immunotherapies in 2019, Transgene has kicked off the New Year by starting trials of a new vaccine for ovarian and head and neck cancers. The French biotech is partnering with artificial intelligence…
Merck & Co joins KRAS gold rush with Taiho and Astex collaboration
US-based Merck & Co has forged an R&D tie-up with Taiho and Astex Pharmaceuticals, focused on developing small molecule drugs targeting the KRAS gene that has become the subject of intense focus in pharma after a landmark trial from Amgen…
Electronic Caregiver, Realtime Senior Living form care partnership
US-based medical technology firm Electronic Caregiver has partnered with Realtime Senior Living to help patients easily locate quality senior living options and care services in real-time. With Realtime Senior Living’s advanced applications, case managers and care coordinators will be able…
US researchers to trial retinal scanning to diagnose Alzheimer’s
Researchers at the University of Rhode Island, Butler Hospital and BayCare Health System have collaborated to launch retinal scanning tests for early detection of Alzheimer’s disease. Morton Plant Mease Health Care Foundation and St Anthony’s Hospital Foundation provided funds for…
Bionic pancreas given FDA Breakthrough Device designation
Medtech company Beta Bionics has received FDA Breakthrough Device designation for its automated bionic pancreas – the iLet Bionic Pancreas System. The iLet Bionic Pancreas System is a pocket-sized, wearable investigational medical device that is designed to autonomously control blood-sugar…